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 EDARBI (azilsartan medoxomil) for the Treatment of Hypertension

/PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved EDARBI (azilsartan medoxomil) for the treatment of hypertension, or high blood pressure, in adults. EDARBI is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone that constricts blood vessels. When the angiotensin II receptor is blocked, blood vessels stay relaxed and open and blood pressure can be reduced. EDARBI is approved as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications.

Takeda Global Research & Development Center, Inc. U.S. submitted a new drug application (NDA) for EDARBI in April 2010. The NDA was supported by seven controlled phase 3 clinical trials involving more than 5,900 patients with hypertension. Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to placebo and the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic and 24-hour mean blood pressure measurements.

"We are pleased to be able to build upon our global expertise in the cardiovascular therapeutic area with the approval of EDARBI in the U.S.," said Shinji Honda, president and CEO, Takeda Pharmaceuticals North America. "Through the discovery, development and commercialization of new medicines, Takeda is committed to bringing therapies like EDARBI to market. EDARBI is an important new treatment option for patients with hypertension and the health care professionals who treat them."

The safety and efficacy of EDARBI were studied as a once-daily oral therapy, as well as in combination with chlorthalidone and amlodipine. Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean systolic blood pressure (SBP) as measured by Ambulatory Blood Pressure Monitoring, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Specifically, results from one study showed EDARBI at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions of EDARBI (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg). Similar results were observed in all three comparator studies. The most common adverse reaction in adults was diarrhea (2%).

About Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation's health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

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Lasers ID Deadly Skin Cancer Better than Doctors

High-resolution images from a laser-based tool developed at Duke University could help doctors better diagnose melanoma, the deadliest form of skin cancer.

The improved diagnoses could potentially save thousands of lives and millions of dollars in unnecessary healthcare costs each year.

The tool probes skin cells using two lasers to pump small amounts of energy, less than that of a laser pointer, into a suspicious mole. Scientists analyze the way the energy redistributes in the skin cells to pinpoint the microscopic locations of different skin pigments.

For the first time, scientists have the ability to identify substantial chemical differences between cancerous and healthy skin tissues, said Thomas Matthews, a Duke graduate student who helped develop the new two-laser microscopy technique.

The Duke team imaged 42 skin slices with the new tool. The images show that melanomas tend to have more eumelanin, a kind of skin pigment, than healthy tissue. Using the amount of eumelanin as a diagnostic criterion, the team used the tool to correctly identify all eleven melanoma samples in the study. The results appear in the Feb. 23 Science Translational Medicine.

The technique will be further tested using thousands of archived skin slices. Studying old samples will verify whether the new technique can identify changes in moles that eventually did become cancerous.

Even if the technique proves, on a large scale, to be 50 percent more accurate than a biopsy, it would prevent about 100,000 false melanoma diagnoses, said Warren S. Warren, director of Duke’s Center for Molecular and Biomolecular Imaging and a chemistry professor. Warren oversaw the development of the new melanoma diagnostic tool.

cancertissueWarren's group has succeeded in using the laser pump method to locate two different types of skin pigments in skin tissue, which may better identify developing melanoma, said James Grichnik, a dermatologist at the University of Miami who was not involved in the study.

The work is limited to fixed tissue on slides, but holds promise for diagnosing melanoma prior to biopsy, and the increased diagnostic accuracy, without unnecessary biopsies, is where the new tool could have cost-saving potential, he said.

Melanoma is the fifth-most common cancer for males and sixth-most common for females. In 2010, U.S. doctors diagnosed nearly 115,000 new cases of the disease, with nearly 8,700 resulting in death. The cancer is also one of the few where the death rate is increasing.

Doctors typically use a light and a magnifying glass or tissue biopsy, where a pathologist removes suspicious skin cells and looks at them under a microscope, to spot signs of disease. But using a lens and a light is a “17th century” technique that is only 85 percent accurate, at best, and tissue biopsy is not much more reliable, Warren said.

In 14 percent of biopsy diagnoses, pathologists would disagree on whether or not the sampled cells were cancerous, according to a 2010 study published in the Journal of American Academy of Dermatology. The statistic implies that two pathologists would have opposing diagnoses on 214,000 to 643,000 melanoma cases each year, Warren said.

When studying biopsied tissue, doctors typically follow the “when in doubt, cut it out” philosophy. If they are not sure about the health of the skin tissue, doctors remove additional skin around the diseased cells. The first and second tissue biopsies can cost thousands of dollars. If the melanoma is thought have spread, patients may then have lymph nodes in their arms removed or undergo chemotherapy, which dramatically adds to treatment costs.

But not all of the extra treatment is necessary because not all of the biopsied tissues are actually cancerous. Doctors need a more accurate way to diagnose melanoma, Warren said.

In 2009, he received a $1 million Challenge Grant from the National Institutes of Health, which was part of the American Recovery and Reinvestment Act of 2009, to develop the imaging tool.

The highly specialized lasers are currently commercially available and would only need to be added to the microscopes pathologists already use to diagnose melanomas. The cost for the added instrumentation is about $100,000, which may sound like a lot of money. But if each false positive melanoma diagnosis costs thousands of dollars, having such an instrument available for questionable cases could considerably reduce health care costs overall, Warren said.

He added that suspicious moles would still have to be removed from a patient and then imaged to detect cancer.

Matthews is working on imaging skin cancers grafted on to mice to see if the tool could become a device dermatologists could use to scan a mole without removing it. A device like that would be much more expensive and would not be ready for a few years, Warren said. However, pathologists could begin using the lasers to study biopsied tissue now.

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Fresenius Medical Care Receives FDA Clearance for 2008K@home™ Dialysis Machine

(BUSINESS WIRE)--Fresenius Medical Care (NYSE: FMS), the world’s leading company devoted to patient-oriented renal therapy, announced today that the U.S. Food and Drug Administration (FDA) cleared its 2008K@home™ dialysis machine. Specifically designed to facilitate hemodialysis treatment in the home environment, the newly approved device offers many patients more options for achieving adequate dialysis in the comfort of their own home.

"The 2008K@home offers the broadest range of dialysis prescription delivery, regardless of patient size or metabolic needs,” said Chief Medical and Regulatory Affairs Officer Jose Diaz-Buxo, MD, FACP. “It offers versatility and the reliability of many years of experience with this platform." The 2008K@home combines the known safety, efficacy and reliability of the 2008® series hemodialysis machines with a simpler user interface and additional new features specifically designed to facilitate home hemodialysis. 2008K@home incorporates all standard performance and safety features expected in modern hemodialysis machines.

The 2008K@home will be available to patients in the late spring/early summer, 2011. For more information call 800-662-1237 ext. 2053.

2008K@home and 2008 are trademarks of Fresenius Medical Care. 

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FDA approves product to prevent bleeding in people with rare genetic defect

The U.S. Food and Drug Administration last week approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

Patients with congenital Factor XIII deficiency don’t make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.

“This product helps fill an important need,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.

The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.

Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse events from abnormal clotting if doses higher than the labeled dose are given to patients.

Corifact is manufactured by CSL Behring of Marburg, Germany.

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FDA permits marketing of first test for most common cause of gastroenteritis outbreaks

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.

Norovirus is a leading cause of food-borne disease outbreaks in the United States.

Acute gastroenteritis is an inflammation of the stomach and intestine that can cause diarrhea, vomiting and stomach pain. Norovirus contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food or water, and by touching contaminated surfaces.

“This test provides an avenue for early identification of norovirus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Early intervention can halt the spread of an outbreak.”

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

The manufacturer demonstrated the performance of the Ridascreen test by comparing results of it to the results of a norovirus reference standard for 609 fecal samples. When the fecal samples were tested with Ridascreen, overall results on average were less sensitive than those of standard reference tests, detecting norovirus across samples about 2/3 of the time it was present.

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a '510(k)' premarket notification.

In March, the U.S. Centers for Disease Control and Prevention will be updating management and disease prevention guidelines for norovirus outbreaks. These guidelines will likely reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.

Ridascreen is made by R-Biopharm AG, located in Darmstadt, Germany.

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FDA clears test to help patients with kidney transplants

The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.

Everolimus, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.

Transplant patients are routinely given drugs that suppress the immune system (immunosuppressants) such as a regimen containing everolimus, cyclosporine, basiliximab, and corticosteroids. These drugs help prevent organ rejection, which occurs when the body’s immune system attacks and destroys a transplanted organ.

Some immunosuppressants are associated with toxic side effects that can injure transplanted kidneys. Balancing the levels of immunosuppressants is critical since transplant patients must take these drugs for the rest of their lives.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

QMS Everolimus is one of a number of FDA-cleared or -approved tests physicians can use to monitor and manage immunosuppressant levels, including tests for cyclosporine, tacrolimus, and sirolimus. These tests, along with careful monitoring of clinical signs and symptoms of organ rejection, tissue biopsies, and other lab tests, may increase the chance of having a successful transplant and possibly extend the survival of a transplanted kidney.

In addition to other evaluations, Thermofisher, the manufacturer of QMS Everolimus, demonstrated the performance of the test by comparing results from the new test to the results from everolimus reference tests used in the clinical trial of everolimus. When the clinical trial blood samples were tested with QMS Everolimus, the results, on average, were similar to those of the clinical trial reference test.

More than 87,000 patients are awaiting a kidney transplant in the United States, according to the Health Resources and Services Administration’s Organ Procurement and Transplantation Network.

QMS Everolimus is manufactured by Waltham, Mass.-based Thermofisher. Zortress is marketed by East Hanover, N.J.-based Novartis.

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FDA approves first 3-D mammography imaging system

The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.

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FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams

/PRNewswire/ -- The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI's magnetic and radiofrequency fields can disrupt the pacemaker's setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker's use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.

"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI."

The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.

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FDA Clears First Diagnostic Radiology Application for Mobile Devices

/PRNewswire/ -- A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.

The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

"This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health.

Radiology images taken in the hospital or physician's office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.

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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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