The More Times a Woman Gives Birth, the Higher Her Risk of Rare but Aggressive 'Triple-Negative' Breast Cancer

/PRNewswire/ -- Full-term pregnancy has long been associated with a reduced risk of breast cancer, but a new study finds that the more times a woman gives birth, the higher her risk of "triple-negative" breast cancer, a relatively uncommon but particularly aggressive subtype of the disease. Conversely, women who never give birth have a 40 percent lower risk of such breast cancer, which has a poorer prognosis than other types of breast cancer and doesn't respond to hormone-blocking therapies such as tamoxifen.

These findings, from a study led by Amanda Phipps, Ph.D., a postdoctoral research associate in the Public Health Sciences Division of Fred Hutchinson Cancer Research Center, are published online ahead of the March 16 issue of the Journal of the National Cancer Institute.

"Unlike most breast cancers, triple-negative tumors don't depend on hormonal exposures to grow and spread, so our assumption going into the study was that reproductive factors would not be associated with a woman's risk of this cancer subtype," Phipps said. "We were surprised by these findings because researchers have known for quite some time that women who have children, especially those who have them at an early age and have multiple full-term pregnancies, have a lower risk of breast cancer overall."

While never giving birth appears to be protective against triple-negative breast cancer, the researchers found that women who remain childless have about a 40 percent higher risk of estrogen-receptor-positive breast cancer - the most common form of the disease, which can be treated with estrogen-blocking drugs - as compared to those who have one or more offspring. This higher risk of estrogen-receptor-positive breast cancer among women who have not had children is well established, and it is thought to be related to the fact that such women do not undergo pregnancy-related changes in the breast that confer a lifelong protective effect.

"The mechanisms by which full-term pregnancy contributes to an increased risk of triple-negative breast cancer and a decreased risk of other forms of the disease are not clear," Phipps said. "We do know that the hormones of pregnancy induce certain changes in the cellular structure of the breast. Overall, those changes seem to make the breast less susceptible to cancer. It is possible, however, that the increased risk of triple-negative breast cancer we found in women who had given birth may be due to some abnormal response of their breast tissue to the hormones of pregnancy. Another possibility is that pregnancy somehow makes the breast more susceptible to certain carcinogens even while reducing breast cancer risk overall," she said.

For the study, which was based on data from the Women's Health Initiative, Phipps and colleagues analyzed the detailed reproductive histories of some 150,000 postmenopausal women, more than 300 of whom went on to develop triple-negative breast cancer. "This particular study is significant because it is one of the largest studies ever conducted on the impact of reproductive history on triple-negative breast cancer," Phipps said.

Triple-negative breast cancer, which refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu, accounts for only 10 percent to 20 percent of all breast cancers, and only in the past decade have researchers become aware that this cancer subtype exists. "This research reinforces the notion that breast cancer is not just one disease," Phipps said.

"The mechanisms that lead to triple-negative breast cancer are likely different from those that lead to other forms of the disease. We still have a lot to learn about what causes this more aggressive form of breast cancer, but we hope that research like this will help us develop better tools to identify those women at greatest risk."

It is known that this cancer subtype is more predominant in African American women and it tends to be diagnosed at an earlier age. Researchers also know there is a strong link between genetic mutations in the so-called "breast cancer gene," BRCA1, and triple-negative breast cancer.

"More research is needed to better understand the causes of the most aggressive and lethal forms of breast cancer. While this study adds to our knowledge base, it should not change women's approaches to breast cancer screening," Phipps said.

The National Heart, Lung and Blood Institute of the National Institutes of Health funded the study, which also involved researchers from Albert Einstein College of Medicine, Georgetown University, Harbor-UCLA Medical Center, Stanford University, State University of New York at Stony Brook, the University of Buffalo, the University of Pittsburgh and Wake Forest University.

At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. www.fhcrc.org

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FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

The FDA approved Makena under the agency's accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here, reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a clinical benefit.

Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit. An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena. Such outcomes include reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.

"Preterm birth is a significant public health issue in the United States," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "This is the first drug approved by the FDA that is indicated to specifically reduce this risk."

A health care provider would give Makena once a week by injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy.

The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. The study included 463 women 16 to 43 years of age who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37 percent delivered early (before 37 weeks) as compared with 55 percent of women in the control group.

A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children ages 2.5 years to 5 years reached similar developmental targets, regardless of the mother's treatment. The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018. That study is expected to include 580-750 infants, depending on the number of study sites and mothers willing to participate.

The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Consumers and health care professionals are encouraged to report adverse events from medications to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Makena is manufactured by Baxter Pharmaceutical Solutions LLC, based in Bloomington, Ind.

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FDA begins process to remove breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today (December 16) that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

Removing the breast cancer indication from the Avastin label will be a process. This is the first step. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

The agency has informed Genentech, Avastin’s manufacturer, of its proposal to withdraw marketing approval of the drug for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, and FDA will begin proceedings to remove the breast cancer indication.

Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA’s accelerated approval program, based on the results of a clinical trial known as “E2100,” which evaluated the drug in patients who had not received chemotherapy for their metastatic HER2-negative breast cancer. Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this. The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.

After the accelerated approval of Avastin for breast cancer, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on “progression-free survival” without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in “progression-free survival” reflects a small, temporary effect in slowing tumor growth.

Avastin has also been associated with several other serious and potentially life-threatening side effects including the risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

On the basis of all available data relating to the use of Avastin to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use.

FDA is open to working with Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug’s benefits exceed the risks.

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Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia

/PRNewswire/ -- Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

"The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia's safety for all patient groups," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.

The agency's analysis of SCOUT was the subject of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.

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Mayo-Led Researchers Discover Genetic Variants Modifying Breast Cancer Risk

Individuals with disrupting mutations in the BRCA1 gene are known to be at substantially increased risk of breast cancer throughout their lives. Now, discoveries from an international research team led by Mayo Clinic researchers show that some of those persons may possess additional genetic variants that modify their risk. These new findings enhancing individualized medicine appear in the current Nature Genetics.

"These findings should be useful in helping determine individual risk for breast cancer in BRCA1 carriers," says Fergus Couch, Ph.D., Mayo investigator and senior author of the study. "It also provides insights into hormone-receptor-negative breast cancer in the general population."

Genetic mutations in the BRCA1 gene give carriers of these mutations an increased risk for developing breast cancer. To determine if any genetic variations would modify or alter this risk among large populations of the mutation carriers, the researchers conducted genome-wide association studies (GWAS) that ultimately spanned 20 research centers in 11 different countries.

They first studied 550,000 genetic alterations from across the human genome in 1,193 carriers of BRCA1 mutations under age 40 who had invasive breast cancer and compared the alterations to those in 1,190 BRCA1 carriers of similar age without breast cancer. The 96 single nucleotide polymorphisms (SNPs) discovered were subsequently studied in a larger sample population of roughly 3,000 BRCA1 carriers with breast cancer and 3,000 carriers without cancer. Researchers found five SNPs associated with breast cancer risk in a region of chromosome 19p13.

Further studies of those SNPs in 6,800 breast cancer patients without BRCA1 mutations showed associations with estrogen-receptor-negative disease, meaning cancer in which tumors don't possess estrogen receptors. In another GWAS involving 2,300 patients, the five SNPs also were associated with triple-negative breast cancer, an aggressive form of the disease accounting for about 12 percent of all breast cancer. Triple-negative tumors don't express genes for estrogen or progesterone receptors or Her2/neu. The researchers also found that these SNPs were not related to risk for ovarian cancer in BRCA1 mutations carriers.

By locating these risk-modifying SNPs, the researchers have provided a target for better understanding the mechanisms behind the development of breast cancer. Furthermore, when combined with other risk-modifying SNPs that remain to be identified in ongoing studies by this group, it may be possible to identify certain BRCA1 carriers who are at lower risk of cancer and, also, carriers at particularly elevated risk of cancer who may decide to change their approach to cancer prevention.

Support for the research came from the Breast Cancer Research Foundation, Susan G. Komen for the Cure, the National Institutes of Health, and Cancer Research UK. In addition to first author Antonis Antoniou, Ph.D., of Cambridge University, over 180 individuals and several consortia contributed to the research and are co-authors.
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Infant's Gaze May Be an Early, but Subtle, Marker for Autism Risk

/PRNewswire/ -- Kennedy Krieger Institute announced today new study results showing an early marker for later communication and social delays in infants at a higher-risk for autism may be infrequent gazing at other people when unprompted. Published in the September issue of the Journal of Child Psychology and Psychiatry, the study also found that six-month-old high-risk infants demonstrated the same level of cause and effect learning skills when compared to low-risk infants of the same age.

The study observed 25 infant siblings of children with autism (high-risk group) and 25 infants with no family history of autism (low-risk group) at six months of age in order to assess cause and effect learning as well as social engagement. Infant siblings of children with autism are considered at high-risk for the disorder, as they are 25 times more likely to develop autism. Researchers at Kennedy Krieger, in collaboration with colleagues at the University of Delaware, created a novel, multi-stimuli social learning task, where infants were seated in a custom chair with an attached joystick within easy reach, a musical toy located to the right and their caregiver on the left. Researchers evaluated how quickly the infant learned that the joystick activated the toy and the infant's level of social engagement with their caregiver.

Researchers found that, like the low-risk group, the high-risk siblings exhibited typical levels of social gazing when their caregivers actively engaged them, such as pointing at the toy and expressing excitement. However, high-risk sibs spent less time looking to their caregivers and more time fixated on the non-social stimuli (toy or joystick) when the caregiver was not engaging them, which could indicate a disruption in development related to joint attention. Joint attention is often a core deficit for children with autism.

"My colleagues and I wanted to create a task that would involve learning something novel and would give babies an opportunity to pay attention to either an object or their caregiver," said Dr. Rebecca Landa, corresponding study author and director of Kennedy Krieger's Center for Autism and Related Disorders. "This study shows that there is a particular vulnerability in high-risk siblings at six months of age. They are not as socially interactive and engaged on their own as their peers, but still respond typically when engaged by their caregivers, making for a subtle difference that could be easily overlooked by both parents and some professionals."

The study also showed no evidence of impaired associative learning in the high-risk siblings. Both groups demonstrated cause and effect learning abilities; once the infants learned that pulling the joystick activated the toy, they increased how often they pulled on the joystick to activate the toy's music. This finding supports past research demonstrating that associative learning is a relative strength in older individuals with autism and may help to explain why children with autism respond well to teaching approaches that utilize a predictable reward system when children exhibit desired behaviors.

"Babies in both groups of the study learned the multi-stimuli task to the same degree," said Dr. Landa. "While the high-risk siblings are at a higher risk for developing autism later in life, they still have the capacity to learn cause and effect as well as their low-risk peers at this young age."

Implications from the overall study findings reveal that like older children, infants at high risk for autism may benefit from frequent exposure to simple cause and effect learning opportunities to aid in their development. For example, Landa recommends using simple songs paired with easy, predictable gestures to promote language and social learning, rather than using electronic toys that children can enjoy and operate without engaging with their peers or caregivers.

It is expected that about 20 percent of the high-risk infants in this study will receive a diagnosis of autism. While participants in this study have not yet reached their third birthday, the age at which the research diagnoses are confirmed, the study findings help to highlight the vulnerability of developing social initiation skills in high-risk infants. This study is the first of its kind, and a follow-up will soon be published from the Center for Autism and Related Disorders at Kennedy Krieger Institute.

The research study was supported by grants from the National Institutes of Mental Health.

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African-Americans Have Higher Risk for Blood Clots After Receiving Drug-Coated Stent

/PRNewswire/ -- African-American race is a distinct risk factor for developing life-threatening blood clots after receiving a drug-coated stent, according to research reported in Circulation: Journal of the American Heart Association.

African-American race was the strongest predictor of clotting that occurs more than 30 days after implantation, researchers said.

For the study, researchers examined data on 7,236 patients who had stents, coated with clot-prevention drugs, implanted to prop open narrowing arteries. The drug-coated stents, also called drug-eluting stents, were implanted between mid-2003 and the end of 2008.

Even after considering other known risk factors -- such as diabetes, hypertension and kidney problems -- researchers found that African-Americans still experienced a higher rate of thrombosis or clotting.

The bottom line is this is not just because this population is sicker or less compliant, but there is something else there that needs to be explored," said Ron Waksman, M.D., the study's lead author.

In the study, African-American patients were nearly three times as likely to experience clotting as non-African-American patients. African-Americans' clotting rates compared to non-African Americans were:

-- 1.71 percent vs. 0.59 percent after 30 days;
-- 2.25 percent vs. 0.79 percent at one year;
-- 2.78 percent vs. 1.09 percent at two years; and
-- 3.67 percent vs. 1.25 percent at three years.


The rate of death from all causes at three years was also higher among African-Americans, 24.9 percent vs. 13.1 percent in other races.

"Physicians and patients need to know that African-Americans are at a higher risk of developing stent thrombosis, which is associated with heart attack or death," said Waksman, associate director of the Division of Cardiology at Washington Hospital Center and professor of medicine and cardiology at Georgetown University.

In the study, African-Americans had increased rates of stent thrombosis even though they took post-surgery anti-clotting medication as prescribed at a higher rate than other races.

Further studies are needed to determine what should be done to reduce the blood clotting risks in African-Americans, Waksman said. Possible genetic differences in the way African-Americans' bodies react to the anti-clotting medication clopidogrel may have an impact.

Clopidogrel, a common drug prescribed post-stent implantation, carries a black box warning on its label from the Food and Drug Administration because the drug loses its ability to keep blood clots from forming in some patients whose bodies have trouble converting clopidogrel to its active form.

In some studies, researchers found that this genetic difference occurs more often in African-Americans than in white patients. Blood tests or genetic testing determine if someone is a "poor metabolizer" of clopidogrel.

More African-American participants are needed in key clinical trials to determine if the treatment works before a drug is on the market, Waksman said. "We are committed to further exploring these disparities and how African-Americans can benefit from drug-eluting stents without increasing the risk of stent thrombosis."

Co-authors are Sara D. Collins, M.D.; Rebecca Torguson, M.P.H.; Michael A. Gaglia Jr., M.D., M.Sc.; Gilles Lemesle, M.D.; Asmir I. Syed, M.D.; Itsik Ben-Dor, M.D.; Yanlin Li, M.D.; Gabriel Maluenda, M.D.; Kimberly Kaneshige, B.S.; Zhenyi Xue, M.S.; Kenneth M. Kent, M.D., Ph.D.; Augusto D. Pichard, M.D.; William O. Suddath, M.D.; and Lowell F. Satler, M.D.

Author disclosures and funding information are on the manuscript.


Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

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FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

/PRNewswire/ -- The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk.

Aseptic meningitis has a number of causes including, but not limited to, viruses, toxic agents, some vaccines, autoimmune diseases, and certain medications, including Lamictal. Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck and sensitivity to light. Hospitalization may be required.

In suspected cases of meningitis, the underlying cause should be rapidly diagnosed so that treatment can be promptly initiated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.

"Aseptic meningitis is a rare but serious side effect of Lamictal use," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Patients that experience symptoms should consult their health care professional immediately."

The FDA became aware of the association between Lamictal and aseptic meningitis through routine adverse event monitoring and communications with the drug's manufacturer. Since the drug's approval in December 1994 through November 2009, there were 40 cases of aseptic meningitis identified in patients taking Lamictal. The symptoms were reported to occur within one to 42 days after starting Lamictal. Thirty-five of the 40 patients required hospitalization. In most cases, symptoms ended after Lamictal was discontinued. In 15 cases, symptoms, often more severe, returned when patients restarted the drug.

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FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler

The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.

COPD is a serious and chronic lung disease that restricts air flow in the lungs resulting in shortness of breath. In the United States, COPD includes two main conditions – emphysema and chronic bronchitis. Spiriva HandiHaler consists of capsules and an inhalation device approved for once daily use in COPD.

A March 2008 FDA Early Communication had described data submitted by the manufacturer of Spiriva HandiHaler as suggesting a small increased risk of stroke in patients treated with tiotropium, the medicine’s active ingredient. In October 2008, an Updated Early Communication highlighted two additional publications suggesting an increased risk of stroke, heart attack, and death in patients using tiotropium.

Today’s update of those communications is based on an FDA review of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study that compared Spiriva HandiHaler with a placebo in 5,992 COPD patients. In November 2009, the FDA Pulmonary – Allergy Drugs Advisory Committee also reviewed the data and voted that findings from the UPLIFT study resolved the potential safety concerns for Spiriva Handihaler.

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FDA: Cancer Warnings Required for TNF Blockers

The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

Today’s action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.



-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

-- Fax: (800) FDA-0178

-- Phone: (800) FDA-1088

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Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful

A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.

The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.

"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals."

CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.

"We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution," said Woodcock.

In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.

The FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, but the agency does not review or approve CMI leaflets. The agency's role, as set forth by Congress, has been to encourage the private sector to provide this information, supply the companies with the necessary guidance and evaluate the private sector's progress.

The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy. Shoppers trained to simulate patients visited pharmacies randomly selected throughout the United States. The shoppers gave the pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. Expert and consumer panels evaluated the quantity and quality of this information.

There were some improvements shown by the new study when compared to a similar evaluation of CMI in 2001, Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. That study revealed that 89 percent of patients received written information when their new prescriptions were filled, but only about 50 percent of the CMI met minimal criteria for usefulness.

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New Biomarker for Heart Failure Identified

Blood levels of resistin, a hormone produced by fat cells, can independently predict an individual¿s risk of heart failure, cardiologists at Emory University School of Medicine have found.

Their findings were presented Nov. 12 at the American Heart Association Scientific Sessions conference in New Orleans.

"This is one of the strongest predictors of new-onset heart failure we've been able to find, and it holds up even when you control for other biomarkers and risk factors including high blood pressure and diabetes," says Javed Butler, MD, MPH, associate professor of medicine and director of heart failure research at Emory University School of Medicine.

The finding comes out of the Health ABC (Aging and Body Composition) study, sponsored by the National Institute on Aging of the National Institutes of Health. The Health ABC study followed 3000 elderly people in the Pittsburgh and Memphis areas over seven years starting in 1998.

Although scientists don't know the exact function of resistin, it appears to be associated with both inflammation and insulin resistance, says Vasiliki Georgiopoulou, MD, a post-doctoral research fellow with Butler who presented these findings. "Recent laboratory studies have also shown that resistin decreases the ability of rats¿ heart muscles to contract," she adds.

In the Health ABC study, the risk of new onset heart failure increased by 38 percent for every 10 nanograms per milliliter increase in resistin levels in blood. Resistin was a stronger predictor of heart failure risk than other inflammatory markers linked to heart disease, such as C-reactive protein, the researchers found.

"Considering the increasing number of people who are obese or have diabetes, very many of them are going to be at some level of risk for heart failure later in life," Butler says. "The value of a marker such as resistin may be in accurately identifying among this large population of at-risk individuals who is at the highest risk and then targeting interventions to those people."

Investigators from several institutions contributed to the study, including the University of Lausanne, Harvard Medical School, University of California San Francisco, University of Pittsburgh, Wake Forest University, Boston University and the National Institute on Aging.

About Emory Heart & Vascular Center Emory Heart & Vascular Center doctors are committed to providing clinically excellent cardiovascular patient care, pioneering innovative clinical research and training the best heart specialists in the world. A component of Emory Healthcare, the Center is consistently recognized by U.S. News & World Report as one of the top heart centers in the country. Emory Healthcare is the clinical arm of Emory University's Woodruff Health Sciences Center and is the largest, most comprehensive health care system in Georgia.

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Breakthrough Mapping of Alzheimer's Genome Helps ID Four New Suspect Genes

PRNewswire-USNewswire/ -- Four novel genes that may significantly increase the risk of the most common form of late-onset Alzheimer's have been identified by researchers at Massachusetts General Hospital and Harvard Medical School, as reported in the November 7th issue of American Journal of Human Genetics. The findings, part of a larger "Alzheimer's Genome Project" (AGP) established three years ago to identify the full set of Alzheimer's disease genetic risk factors, may lead to more aggressive therapeutic interventions to slow, stop or even reverse the effects of the disease. These new therapies would differ from current treatments that only address the symptoms of the disease.

Dr. Rudolph Tanzi, chairman of the Cure Alzheimer's Fund Research Consortium and the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard Medical School, completed the largest family-based genome-wide association screen conducted to date. More than 400 families affected by Alzheimer's disease were screened to determine genetic variants associated with the inheritance of Alzheimer's. The four genes discovered in the family study are described in the article.

Technological advances are improving the understanding of the genetic mechanism that governs Alzheimer's disease and are making it feasible to identify the complete set of genes influencing risk for Alzheimer's disease, Dr. Tanzi said.

In addition to the genome-wide association screen, Dr. Tanzi and Dr. Lars Bertram of Harvard Medical School have been analyzing Alzheimer's genetics literature to determine which of the hundreds of proposed Alzheimer's candidate genes are genuine disease genetic risk factors. These summarized findings, implicating 30 gene candidates, are updated regularly at http://alzgene.org/ (a public Web site sponsored by the Cure Alzheimer's Fund). Tanzi and Bertram highlighted 10 of the most interesting of these genes in the current issue of Nature Reviews Neuroscience. Ultimately, the goal is to combine the results of the Alzheimer's family-based genome-wide association screen with the bioinformatics results of AlzGene.org.

The combined efforts of the family-based genome-wide association screen and AlzGene.org studies have led to the identification of 70 genes containing variants that either confer risk for, or protect against, Alzheimer's, making up the most comprehensive genetic map of the disease.

"This project is the most complete and comprehensive search for the genes that cause Alzheimer's disease published to date," Tanzi said. "Our hope is to use this new information to not only better diagnose and someday predict risk for Alzheimer's but to also learn from these genes the biological causes of Alzheimer's. The knowledge gained from understanding the Alzheimer's-associated defects in these genes will almost certainly accelerate the development of novel therapeutics and hopefully lead to a potential cure for this devastating disease."

The current understanding of the causes and pathological progression of Alzheimer's disease have been made possible by studies of four Alzheimer's genes discovered between 1987 and 1995, three of which were co-discovered by Tanzi. Since these genes account for only 30 percent of the genetic basis of Alzheimer's disease, three years ago Cure Alzheimer's Fund initiated the Alzheimer's Genome Project aimed at determining the remaining 70 percent of the genetic basis of Alzheimer's disease. Taking advantage of major technological and analytical breakthroughs in human genetic studies, the project was able to reach this milestone with a limited budget, led by a contribution of $3 million from Cure Alzheimer's Fund.

"We are on the cusp of a rare 'science moment' that could alter the way we diagnose, treat and prevent Alzheimer's disease," said Tanzi. "Ultimately, the combined results of the family-based genome-wide screen and AlzGene.org will allow for the reliable prediction of Alzheimer's disease while also guiding the development of therapies."

Alzheimer's disease is the most common cause of dementia in the elderly and a burgeoning unmet medical need that only will worsen as individuals continue to live longer. The Alzheimer's Association estimates that as many as 5.2 million Americans are living with Alzheimer's disease, including between 200,000 and 500,000 people under age 65 with young-onset Alzheimer's disease or other dementias. Experts predict that, by 2010, nearly a half million new cases of Alzheimer's disease will occur each year; and by 2050, nearly a million new cases will occur annually.

Cure Alzheimer's Fund has no endowment and passes funds raised directly to selected research as determined by the Cure Alzheimer's Research Consortium. The Foundation has no financial or intellectual property interest in the research funded, and will make known the results of all funded research as soon as possible. At a time when the federal government investment for Alzheimer's research and education is decreasing, Cure Alzheimer's Fund has raised more than $10 million, investing all of it directly into research.

Cure Alzheimer's Fund(TM) is a 501c3 public charity established to fund targeted research with the highest probability of slowing, stopping or reversing Alzheimer's disease. For more information, please visit http://www.curealzfund.org/.

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Poor Perioperative Blood Pressure Control Linked to 30-Day Morbidity and Mortality in Cardiac Surgery Patients

Business Wire - The Medicines Company (NASDAQ: MDCO) announced October 21, 2008, that poor blood pressure control during cardiac surgery is associated with a higher risk of 30-day death, stroke, myocardial infarction and renal dysfunction, compared to patients with tight blood pressure control, according to a post-hoc analysis of the ECLIPSE trial. The data were presented at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting.

“In this analysis, what we found was clear: the worse the blood pressure control, the poorer the outcome in these cardiac surgery patients,” said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. “These data support the need to more effectively manage blood pressure in the surgical and critical care settings.”

The ECLIPSE trial enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex™ (clevidipine butyrate) injectable emulsion to nitroglycerin, sodium nitroprusside or nicardipine. In this post-hoc analysis, 1507 ECLIPSE patients were stratified by precision of blood pressure control measured as excursions and time out of a pre-specified range. Adverse outcomes, assessed as death, myocardial infarction, stroke and renal dysfunction at 30 days post-discharge, were significantly higher in patients with poor blood pressure control (14.4%) than in patients with tight blood pressure control (8.8%).

“These critical new findings underscore the risk posed by uncontrolled blood pressure during cardiac surgery and emphasize the need for tight blood pressure control in these patients,” said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. “Cleviprex, recently approved by the FDA, provides physicians with an important, new clinical tool for achieving rapid and predictable blood pressure control.”

Additional post-hoc data from the pivotal ECLIPSE program, involving patients undergoing cardiac valve surgery, will be presented at the American College of Chest Physicians (ACCP) annual meeting in Philadelphia on Tuesday, October 28, 2008.

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Early Exposure To Drugs, Alcohol Creates Lifetime Of Health Risk

People who began drinking and using marijuana regularly prior to their 15th birthday face a higher risk of early pregnancy, as well as a pattern of school failure, substance dependence, sexually-transmitted disease and criminal convictions that lasts into their 30s.

A study published online by the journal Psychological Science has been able to sort out for the first time the difficult question of whether it's bad kids who do drugs, or doing drugs that makes kids bad.

The answer is both, said Duke University psychologist Avshalom Caspi, who co-authored the report with his wife and colleague Terrie Moffitt. They are part of a team of researchers from the U.S., Britain and New Zealand that analyzed data tracking the health of nearly 1,000 New Zealand residents from birth through age 32.

Half of the study subjects who were using alcohol and marijuana regularly before age 15 were indeed the so-called "bad kids" who came from an abusive, criminal or substance-abusing household and had behavior problems as children.

But the other half were the "good kids" from more stable backgrounds, and they also ended up in poorer health in their 30s.

Caspi said it is clear from these data that adolescent exposure to drugs and alcohol can make a good kid veer off on a bad trajectory. "The good kids who do drugs end up looking like the bad kids who didn't do drugs," Caspi said.

The "good kids," who were without behavior problems as children and didn't have any of the family risk factors, but who began using drugs and alcohol before 15, ended up being 3.6 times more likely to be dependent on substances at age 32. They were also more likely than the other good kids to wind up with a criminal conviction and a herpes infection.

Good and bad, the adolescents who regularly used drugs and alcohol "all had poorer health as adults," Caspi said. "This is consistent with a growing body of evidence that early adolescence may be a sensitive time for exposure to alcohol and other drugs."

He noted however, that the study is not concerned with a kid who tries alcohol a couple of times or who takes a toke at a party. "These are kids who, by the age of 15, are invested in it, purchasing drugs and alcohol and using regularly."

A third of the girls from the "good kids" group were pregnant before age 21 if they had been using drugs and alcohol regularly. That's the same number of pregnancies as the "bad kids" who didn't use drugs. Two-thirds of the "bad kids" who used before 15 were pregnant before age 21. By comparison, only 12 percent of "good" girls who were non-users had early pregnancies.

“Even adolescents with no prior history of behavioral problems or family history of substance use problems were at risk for poor health outcomes if they used substances prior to age 15," said first author Candice Odgers of the University of California-Irvine, who did a post-doctoral fellowship with Caspi and Moffitt. "Universal interventions are required to ensure that all children -- not just those entering early adolescence on an at-risk trajectory -- receive an adequate dose of prevention.”

Because the study has tracked these people from birth, "we know pretty much everything about them and we can sort out these things," Caspi said. "We have rich data on these kids' lives and their family situation before they started to do drugs."

The study was funded by the National Institute of Mental Health, the U.K. Medical Research Council, the William T. Grant Foundation, the Health Research Council of New Zealand, and a National Institute on Drug Abuse grant to the Duke University Transdisciplinary Prevention Research Center.

Other authors of the Psychological Science paper include Daniel Nagin of Carnegie Mellon University; Barry Milne of King's College, London; Alex Piquero of the University of Maryland, College Park; Wendy Slutske of the University of Missouri-Columbia; and Nigel Dickson and Richie Poulton of the University of Otago in New Zealand.

By Karl Leif Bates

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

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FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:

* Drug labeling, including patient labeling, professional labeling, and patient package inserts;
* Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
* A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
* Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
* Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
* Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
* Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
* Regulations and guidance documents;
* Consumer information about using medications safely and disposing of unused medicines;
* Instructions how to report problems to the FDA through its MedWatch program;
* Consumer articles on drug safety; and
* The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.

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FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

The FDA's paper, "An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in the FDA's spontaneous adverse event reporting system," documents that during the course of long-term placebo-controlled clinical trials, nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. From this data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years.

"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis (ALS) in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted," said Dr. Avigan.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Dr. Lorene Nelson, Chief of the Division of Epidemiology, Stanford University School of Medicine, and colleagues at the Division of Research, Kaiser Permanente. Results from this study should be available within 6-9 months. FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

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More Children Becoming Stroke Victims

HHH Note: This story by Consumer Affairs really opened our eyes as to the potential dangers that some children at risk face. We thought you'd be interested in it as well.

Older adults are not the only people in danger of suffering a stroke. Increasingly, children are also stricken, according to the American Heart Association/American Stroke Association. In fact, it happens often enough....

Read the story.