FDA, health organizations to study safety of medications taken during pregnancy
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.”
Decision Resources projects same U.S., Europe patient share of ulcerative colitis biologic
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.
HHS debuts H1N1 vaccine ad during football games
WASHINGTON The Department of Health and Human Services is continuing to advocate getting the H1N1 influenza vaccine, even this late into the season, as the agency announced last week the launch of a new H1N1 flu vaccination advertisement that aired during four college football bowl games held over the New Year’s holiday.
The ad is aimed at encouraging young people and all Americans to get vaccinated against the H1N1 flu.
“Young Americans have been especially hard hit by the 2009 H1N1 flu,” stated HHS secretary Sebelius. “Sports events are important opportunities to encourage fans, athletes, young adults and all Americans to protect themselves by getting the H1N1 vaccine. We hope that college athletic teams across the country will continue to join us in the fight against the H1N1 flu by getting vaccinated and encouraging others to get vaccinated too.”
With more than 110 million doses of the 2009 H1N1 vaccine now available, “all Americans are encouraged to get vaccinated and protect themselves and their loved ones during flu season, which typically lasts from October until May,” the agency stated.
For the week ended Dec. 26, rates of reported influenza-like illnesses continued to decline, though nationwide ILI incidence is still higher than is typical for this time of the year.