New Drug Information Proposed for Pregnancy

New Drug Information Proposed for Pregnant Women

By Dulce Zamora

Jan. 11 (CBSHealthWatch)--Women who must take medications during pregnancy may soon have more guidance on the safety of those drugs. In the next couple of weeks, the Food and Drug Administration (FDA) plans to propose a rule that would, every 6 months, require drug makers to disclose the risks and benefits their products may have for expecting women.

Currently, drug companies collect reports on their own about side effects related to pregnancy. The FDA's proposal would open cases of adverse events up for federal scrutiny.

"If there's enough information there to warrant putting some information into the labeling [of drugs] to serve as a warning to physicians prescribing a product for a pregnant woman, then that's what the agency will do," says Crystal Rice, a spokesperson for the FDA's Center for Drug Evaluation and Research.

Diane Kennedy, project manager of the FDA's Pregnancy Labeling Task Force, says the reporting rule is a part of a larger postmarketing surveillance proposal that attempts to standardize manufacturers' reports for different countries. Kennedy says the proposal identifies pregnant women as one of the special populations needing extra consideration.

Separate from the reporting rule, sometime this year the FDA also plans to make the pregnancy section of drug labeling more useful to expectant women and their doctors.

"Our current labeling is really not helpful in that regard," says Kennedy. "Usually the labels would just say, 'Use only in pregnancy if the benefits outweigh the risks.' But we have no idea what the benefits are because they never study drugs in pregnancy, and we don't know what the risks are, because there's no requirement that they monitor for that."

Kennedy says the lack of information has made it difficult for doctors to prescribe certain drugs to expectant women. Physicians are cautious about recommending certain medicines, she notes, because a woman's physiology changes dramatically during pregnancy.

It's rare to find women to who are not exposed to drugs during pregnancy, says Beth Conover, a genetics counselor at the Nebraska Teratogen Information Service at the University of Nebraska Medical Center in Omaha. She advises women who are concerned about exposure to certain drugs, either inadvertently or because they have to take them for a chronic conditions such as depression, asthma, or epilepsy.

Conover says it's best for a woman who is thinking about having a baby to discuss her medications before becoming pregnant. But, if a woman is expecting and needs to discuss the effects of medicines, Conover suggests calling the Organization of Teratology Information Services (OTIS) at 888-285-3410, or tapping into the OTIS Web site(www.otispregnancy.org).