Asthma Study Announced

Asthma and Flu Study Announced is reporting that researchers from Boston University are embarking on a national study of women who take medications or get vaccinated while they are pregnant, starting with flu and asthma treatments because they are widely taken and a common cause of concern.

BU’s Slone Epidemiology Center will compare women whose babies have major birth defects to mothers of normal babies, assessing their exposure to asthma medications, seasonal and H1N1 vaccine, and antiviral drugs such as Tamiflu. Based on information obtained from hospitals and birth registries, the researchers will interview mothers by telephone in Massachusetts, Philadelphia, San Diego, and New York state.

In another arm of the study, the Organization of Teratology Information Specialists will enroll pregnant women who use these medications or vaccines and compare them to pregnant women who don’t, following both groups after the babies are born.

“Our hope is to offer reassurance that a previously neglected area is going to receive some attention,” Slone director Dr. Allen Mitchell said in an interview.

Asthma drugs are the most commonly prescribed medications for pregnant women, he said, and health officials have noted pregnant women’s concerns about flu vaccine and medications.

“It’s not as though there’s good evidence that any of these agents are causing major problems,” Mitchell said. “Rather, there isn’t much data in the first place and some of the little data there are, are conflicting. Our hope is a large, rigorous study will be able to provide some credible answers.”

The study is funded by two federal bodies. The Agency for Healthcare Research and Quality is giving $2.5 million over five years and the Biomedical Advanced Research and Development Authority is spending $7.5 million for two years. Both grants are renewable. The effort, called the Vaccines and Medications in Pregnancy Surveillance System, or VAMPSS, is coordinated by the American Academy of Allergy, Asthma, and Immunology.

While the initial focus will be on flu and asthma, the surveillance system could be adapted to study other products pregnant women take in order to fill gaps in medical evidence, Mitchell said. “Postmarketing studies of drugs in pregnancy have been extremely haphazard.”

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