FDA approves new drug to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States.

Roflumilast, a new drug class for the treatment of COPD, is an inhibitor of an enzyme called phosphodiesterase type 4 (PDE-4). It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD which involves primary emphysema.

“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease.”

The safety and effectiveness of roflumilast was demonstrated in two Phase 3 clinical studies that included more than 1,500 patients ages 40 and older who received roflumilast. Those treated had a history of COPD associated with chronic bronchitis and had experienced an exacerbation of the disease during the 12 months prior to beginning treatment.

The FDA approved roflumilast with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.

Roflumilast should not be used to treat sudden breathing problems (acute bronchospam), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.

Roflumilast is marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.

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FDA clears Cymbalta to treat chronic musculoskeletal pain

The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004.

“Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This approval means that many of those people now have another treatment option.”

Since its initial approval, about 30 million patients in the United States have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.

More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing data from the previously approved patient populations.

The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.

While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective.

The recommended dose for Cymbalta is a 60 milligram capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.

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

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.

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FDA approves Botox to treat chronic migraine

The U.S. Food and Drug Administration today (October 15) approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.

“Chronic migraine is one of the most disabling forms of headache,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine is three times more common in women than in men. Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine.

To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. It is important that patients discuss with their physician whether Botox is appropriate for them.

The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache.

OnabotulinumtoxinA, marketed as Botox and Botox Cosmetic, has a boxed warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when Botox Cosmetic has been used at the recommended dose to improve frown lines.


Botox is manufactured by Allergan Inc. of Irvine, Calif.

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Chronic Health Conditions Common for Stem Cell Transplant Survivors

/PRNewswire/ -- Although hematopoietic cell transplantation (HCT) cures many blood diseases, two-thirds of long-term survivors report at least one chronic health condition after the procedure, according to a recent study published online in Blood, the journal of the American Society of Hematology. Overall, these patients were three and a half times more likely to develop a severe or life-threatening health condition, such as cardiovascular, endocrine, or musculoskeletal problems, as well as new cancers, when compared with their cancer-free siblings.

"Although hematopoietic cell transplants have helped thousands of patients survive cancer, the burden of chronic illnesses borne by these survivors is substantial," said senior study author Smita Bhatia, MD, MPH, professor and Ruth Ziegler Chair in Population Sciences at City of Hope Comprehensive Cancer Center in Duarte, CA. "We hope the results of this study build awareness of the problem to help ensure a continued high quality of life among transplant survivors through life-long follow-up and proactive care."

It is estimated that more than 45,000 patients undergo HCTs each year to combat life-threatening diseases such as leukemia, lymphoma, and aplastic anemia. The procedure restores blood-forming cells in the patient's bone marrow that have been destroyed by anti-cancer treatments, such as chemotherapy. Although previous studies have shown that more than 70 percent of those who survive the first two years after HCT are expected to become long-term survivors, the elimination of the cancer has not always led to a full restoration of health. The high-intensity chemo- and radiotherapies needed prior to transplantation can damage many organs and have a negative impact on the overall health of HCT survivors.

The researchers for this study examined the prevalence and severity of chronic health conditions reported by 1,022 HCT survivors who received their transplants at City of Hope or the University of Minnesota between 1974 and 1998 for a blood cancer or severe aplastic anemia. The results were compared to those of 309 siblings of the participants. Each of the HCT survivors and siblings completed a questionnaire, which included questions regarding physical health conditions, access to and use of medical care, and sociodemographic characteristics.

The results showed that chronic health conditions were widespread in the HCT survivors. Sixty-six percent of these patients reported at least one chronic condition, half reported at least two chronic health conditions, and more than a third (35 percent) reported three or more conditions. In comparison, 39 percent of the siblings reported at least one chronic health condition, but only 15 percent had two or more conditions, and 6 percent had three or more. A severity score of grade 1 (mild) through 4 (life-threatening) was also assigned to each health condition. Mild and moderate conditions include ocular issues, hearing impairment, hypertension, and sensory problems while severe conditions include cardiovascular, gastrointestinal, and muscuskeletal problems, as well as new malignancies. In the HCT cohort, 18 percent reported conditions of the severest level (grade 3 or 4), while only 8 percent of the sibling group had grade 3 or 4 conditions.

Additionally, 53 percent of the HCT survivors who had received grafts from a donor experienced chronic graft-versus-host disease (GVHD), a complication in which the foreign transplanted cells attack the cells in the recipient's body. Although GVHD is treatable, this complication contributed significantly to the increased risk of multiple severe or life-threatening conditions in these patients. Among the survivors with GVHD, nearly one-quarter had severe or life-threatening conditions such as cardiovascular and gastrointestinal disorders, and more than half had two or more health conditions.

The researchers concluded that HCT survivors have a high rate of illness due to chronic health conditions, especially those with chronic GVHD, and recommended that health-care providers conduct systematic and targeted follow-up of these high-risk patients.

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Pediatric Cancer Survivors at Risk for Chronic Illnesses that May Cause Heart Disease

Survivors of pediatric cancer are at greater risk for high cholesterol, diabetes and high blood pressure, all of which predispose them to heart disease.

These risk factors for heart disease are being found at an earlier age than in the general population, according to research published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Lillian R. Meacham, MD, professor of pediatrics at Emory University and medical director of the Aflac Cancer Center of Children's Healthcare of Atlanta Cancer Survivor Program, used data from the Childhood Cancer Survivor Study, which included 8,599 cancer survivors and 2,936 of their siblings.

"In data previously published from the Childhood Cancer Survivor Study, pediatric cancer survivors were found to be at almost 10-fold greater risk for cardiovascular disease than their non-survivor counterparts," says Meacham. "In this study we identified whether the predisposing risk factors for cardiovascular disease - obesity, hypertension, hyperlipidemea and diabetes - were present at higher rates compared to siblings. If the risk factors could be recognized and treated early it is hoped some of the long-term cardiac side effects could be averted."

Meacham found that cancer survivors were nearly twice as likely as their siblings to take medication for high blood pressure, 60 percent more likely to take cholesterol medication and 70 percent more likely to have diabetes.

Radiation treatment may be playing a role in the development of risk factors for cardiovascular disease, Meacham says. Total body irradiation was linked with a 5.5-fold increased risk and chest and abdomen radiation a 2.2-fold increased risk of cardiovascular risk factor clustering, which when present is associated with subsequent cardiovascular disease.

"Mechanistically, we are not yet sure why this is, but the association is definitely there," says Meacham.

Researchers examined the presence of cardiovascular risk factors and found that physical inactivity among cancer survivors was linked with a 70 percent increased risk for cardiovascular risk factor clustering. Older age at the time of the study was linked to a 8.2-fold increased risk for cardiovascular risk factor clustering among survivors compared with children who had never had cancer.

"These risk factors are manifesting at about age 32, which is much younger than a non-cancer survivor would exhibit signs of cardiovascular risk factors," says Meacham. "Some have suggested that when you are a cancer survivor there are parts of you that wear out early, so we need to be vigilant about our follow-up of these patients in order to find these late effects early and intervene."

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HHS Announces $27 Million from Recovery Act to Help Older Americans Fight Chronic Disease

HHS Secretary Kathleen Sebelius has announced the availability of $27 million to help older individuals with chronic conditions to improve their health and reduce their use of costly medical care. These funds are made possible through the American Recovery and Reinvestment Act, which has provided up to $650 million to HHS for the Communities Putting Prevention to Work initiative launched earlier this fall to promote evidence-based prevention strategies in communities and states across the country.

"This program is about getting money to communities to help seniors manage chronic conditions that threaten their ability to remain in their own homes. Through HHS' national aging-services network which reaches into nearly every community in America, we are helping people living with chronic conditions and others better manage their own health," Secretary Sebelius said.

Research has shown that prevention programs can improve the quality of life for older individuals, including frail seniors with multiple chronic conditions, and also reduce health care costs. The Recovery Act funds will put the results of HHS' research investments into practice at
more than 1,200 community-based sites across the country -- reaching tens of thousands of older Americans and their families.

"The American Recovery and Reinvestment Act has been about helping families in need during challenging economic times, " said Assistant Secretary for Aging Kathy Greenlee. "This innovative program will give at-risk older people and their caregivers the tools they need to make their own decisions so they can live longer, healthier and more independent lives."

This competitive initiative gives every state Aging and Health Department and U.S. territory the opportunity to implement rigorously tested Chronic Disease Self-Management Programs (CDSMP), one of the most prominent being the Stanford University model. The CDSMP is a six-week peer-led training program that covers topics such as healthy eating, exercise, managing fatigue and depression, and communicating effectively with health care professionals. While further research is underway, rigorous evaluations have suggested that the program improves
participants' overall health and energy levels and result in savings to Medicare through fewer hospital stays. CDSMP are specifically designed to be delivered by non-health professionals in community settings, such as senior centers, congregate meal programs, faith-based organizations and senior housing projects.

"Too many seniors do not receive the recommended preventive and primary care they need," said Assistant Secretary for Health, Dr. Howard K. Koh. "This program will strengthen the health care that our seniors need and deserve by coordinating and integrating care in the community."

Eligible entities include all 50 states and U.S. territories. States will identify the communities and the organizations that will be involved locally in the delivery of this program. The deadline for applications is Feb. 12, 2010.

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FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis

The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.

“Today’s approval provides another treatment option for patients with these three debilitating disorders,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class."

Simponi is injected under the skin. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Simponi is in a class of drugs that 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. Like other TNF- α blockers, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber’s understand the drug’s risks.

The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion.

Simponi is marketed by Centocor Ortho Biotech Inc., Malvern, Pa.

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PID Diagnosis Predicts Future STI's in Teenagers

A study among Baltimore inner-city teenage girls treated for pelvic inflammatory disease shows they are highly vulnerable to subsequent sexually transmitted infections (STI) — sometimes within a few weeks or months of their treatment.

Results of the research by Johns Hopkins Children’s Center investigators, reported in the November issue of Archives of Pediatric and Adolescent Medicine, suggest that treating pelvic inflammatory disease (PID) “with a prescription and a brochure” is simply not enough to change behavior and prevent future infections, according to lead investigator Maria Trent, M.D., M.P.H., a pediatrician and adolescent medicine specialist at Hopkins Children’s.

Repeat infections can increase a teenager’s risk for chronic pelvic pain, ectopic pregnancies and infertility.

“Because our findings show that PID is not a single isolated incident, doctors should look for ways to change behaviors in these girls and not just treat the acute clinical episode,” said Trent. “We are talking counseling, we are talking strict follow-up and, most importantly, we need to develop new strategies that actually work.”

While cautioning that the study was limited to Baltimore City girls, the researchers say teenage girls across the country’s urban areas likely face similar problems linked to inner-city life and practice behaviors that put them at high risk for repeat STIs.

In the four-year study of 110 girls ages 15 to 21 and diagnosed with PID, 80 girls returned for follow-up during the 48-month study period. Under the Hopkins protocol, those with confirmed diagnosis of PID are given a course of free medication and asked to return within 72 hours and advised to follow up again at three and again in six months with a primary-care provider.

Of the 80, 27(34 percent) were diagnosed with at least one subsequent sexually transmitted infection over a six-month period. Of the 27, eight (30 percent) had two or more STIs in the six-month period.

Getting girls to come back is challenging, researchers say. An earlier study by the Hopkins Children’s group found that only 38 percent of girls diagnosed with PID could be reached, and of these only 43 percent returned for follow-up care.

The best — and narrow — window of opportunity to counsel girls, researchers say, may be at the time of diagnosis or when they return for the repeat screening in 72 hours. This counseling, moreover, must be more thorough, not just admonitions to practice safe sex or not to have sex at all.

“What we think we need is individually tailored counseling by a clinical provider that is done after an in-depth interview with each patient to determine what aspects of her behavior put her at risk and must change,” Trent says.

Researchers are currently testing a pilot program that involves showing an educational video to teenage girls coming to the ED with PID. The Hopkins team also plans to test the value of house calls to patients by a nurse within 72 hours of diagnosis.

Funding for this research came from the Thomas Wilson Sanitarium Foundation for the Children of Baltimore City, the Robert Wood Johnson Foundation and the Centers for Disease Control and Prevention.

Other investigators in the study: Jonathan Ellen, M.D.; Shang-en Chung, M.Sc.; Lynette Forrest, all of Hopkins.

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