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PREGNANCY & CHILDBIRTH | FDA Proposes New Drug Labeling Requirements Detailing Risks to Pregnant Women, Fetuses

PREGNANCY & CHILDBIRTH | FDA Proposes New Drug Labeling Requirements Detailing Risks to Pregnant Women, Fetuses
[May 29, 2008]

On Wednesday, FDA released a proposed rule to require that updated safety information detailing the risks of drugs for pregnant and breastfeeding women -- as well as for fetuses and breastfed infants -- be added to drug labels, the Wall Street Journal reports.

FDA began requiring information on drugs' risks for pregnant women in 1979 and has not changed the policy since then. Some health care professionals have said the current system is overly simplistic, confusing and inaccurate, according to FDA. The current system assigns letters -- A, B, C, D and X -- to all drugs indicating different levels of risk for pregnant women who take the medications. Drugs assigned an A label have a very low risk of fetal harm, while drugs with an X label pose a high risk to fetuses (Favole, Wall Street Journal, 5/29). Drugs assigned B, C or D labels have different levels of risk for pregnant women and varying levels of evidence about risk (AP/Chicago Tribune, 5/28).

The proposed rule, which FDA began working on in 1997, would require drug labels to include three sections -- a fetal risk summary, clinical considerations and data. The fetal risk summary would explain the known risks of a drug for fetuses and whether the risk is based on findings from animal or human trials. The clinical considerations section would provide information about the effects of a drug if women take it before they know they are pregnant. The second section also would detail the risks of the illness to women and fetuses, dosing information and how to address complications. The data section would describe the available information on a drug's use in human and animal trials that was used in developing the risk summary section (Reinberg, HealthDay/Washington Post, 5/28). Pharmaceutical companies also would be required to keep label information up to date (Szabo, USA Today, 5/29).

FDA will offer a final rule on the issue "as soon as possible" following a 90-day public comment period, Sandra Kweder, deputy director of FDA's Office of New Drugs, said. If the rule takes effect, newly approved drugs would be required to follow the requirement immediately, while existing medications will have several years to comply, Kweder said (Cohen, Newark Star-Ledger, 5/29). According to USA Today, pregnant women take an average of three to five medications during pregnancy, and more than 90% of breastfeeding women take medication during the first week after giving birth (USA Today, 5/29).


According to the Journal, drug labeling for pregnancy-related effects is "delicate" because many drugs have different effects for women and fetuses (Wall Street Journal, 5/29). "The system of letter categories has led to an inaccurate and overly simplified view of prescribing in pregnancy," Kweder said, adding, "This system also makes it very difficult to update labeling as new information becomes available," Kweder said (HealthDay/Washington Post, 5/28).

FDA Commissioner Andrew von Eschenbach said the agency "wants to provide the right information in an appropriate way to address" the common question among pregnant women of whether a drug will harm their fetuses (Newark Star-Ledger, 5/29). Von Eschenbach added that the "most important tool the FDA has to carry out its mission to protect and promote the health of every single American is the legal authority we've been given to determine the content and the format of labeling" (HealthDay/Washington Post, 5/28).

The proposed rule and further information on the issue is available online on FDA's Web site.