HEALTH

FDA, health organizations to study safety of medications taken during pregnancy

BY Michael Johnsen

SILVER SPRING, Md. A new research program called the Medication Exposure in Pregnancy Risk Evaluation will fund research to study the effects of prescription medications used during pregnancy, the Food and Drug Administration announced last week.

The program is a collaboration among FDA and researchers at the HMO Research Network Center for Education and Research in Therapeutics, Kaiser Permanente’s multiple research centers and Vanderbilt University.

About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.

“This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” stated Margaret Hamburg, FDA commissioner. “These data will guide regulatory policy and influence medical practice.”

To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link healthcare information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have healthcare information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network.

“This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” stated Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.”

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Decision Resources projects same U.S., Europe patient share of ulcerative colitis biologic

BY Allison Cerra

WALTHAM, Mass. A new report by Decision Resources revealed that a biological therapy with a mechanism of action other than tumor necrosis factor-alpha inhibitors, used for the treatment of moderate to severe ulcerative colitis, would earn a 25% patient share in both the United States and Europe.

The report, “Ulcerative Colitis: Gastroenterologists Identify Emerging Drugs That Will Challenge the Benchmark Therapy Infliximab for Moderate to Severe UC,” finds that two emerging TNF-alpha inhibitors — Abbott/Eisai’s Humira and Centocor Ortho Biotech/Merck/Mitsubishi Tanabe Pharma/Janssen’s Simponi — will earn Decision Resources’ proprietary clinical gold standard status for ulcerative colitis in 2013 following their approval for the indication. Both Humira and Simponi have competitive advantages over sales-leader Remicade in efficacy, delivery, and safety and tolerability.

“Although clinical trial data are limited, interviewed experts believe that both Humira and Simponi’s fully human composition will translate into incremental advantages in efficacy for maintenance of remission and maintenance of response compared to Remicade, which is a chimeric monoclonal antibody,” said Decision Resources analyst Kathryn Benton.

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Mayo Clinic study notes St. John’s wort ineffective in treating IBS

BY Allison Cerra

ROCHESTER, Minn. A Mayo Clinic research study published in the January issue of The American Journal of Gastroenterology found that St. John’s wort is not an effective treatment for irritable bowel syndrome.

While antidepressants are frequently used to treat IBS, to date, no study has examined the success of using the herbal supplement St. John’s wort in treating IBS.

“Our study investigated if herbal antidepressants such as St. John’s wort could benefit irritable bowel disease patients,” says Yuri Saito, M.D., M.P.H., gastroenterologist and lead physician scientist on the study. “Several of the chemical neurotransmitters that are in the brain are also in the colon. Therefore, it’s been thought that antidepressants may affect sensation in the colon in a similar way to how they affect sensation in the brain. Our goal was to evaluate the usefulness of St John’s wort in treating IBS.”

In this placebo-controlled trial, 70 participants with IBS were randomized where half the patients received St. John’s wort and the other half received a placebo for three months. In all, 86 percent of the participants were women, and the median age was 42 years. After three months of observing symptoms such as stomach pain, diarrhea, constipation and bloating, Mayo researchers found that the placebo group had a better response than the group taking the herbal supplement, St. John’s wort.

“Because people tend to struggle with IBS for several years, patients are really looking for inexpensive, over-the-counter treatments such as St. John’s wort,” Saito said. “Unfortunately, our study showed that St. John’s wort was not successful in helping IBS patients.”

St. John’s wort is an herbal supplement derived from the St. John’s wort plant. It has been shown to be helpful in such several medical conditions as depression, as well as other pain syndromes. Research has shown it to be as effective as conventional, prescription antidepressants in treating mild to moderate depression.

“The challenge with IBS is that there is no cure, no one treatment tends to be wholly effective and some treatments come with significant side effects,” Saito said. “However, well-designed studies of herbal supplements are important so that physicians and patients can make informed decisions about which supplements to recommend or try. Studies of alternative treatments are generally lacking and patients are forced to use a ‘trial and error’ approach to over-the-counter treatments for their IBS.”

IBS is a common disorder that affects the colon and commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. Approximately 58 million people struggle with IBS, mostly women.

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