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FDA Revises Prescription Drug Labeling Rules for Pregnancy, Breastfeeding Risks

FDA Revises Prescription Drug Labeling Rules for Pregnancy, Breastfeeding Risks

December 4, 2014 FDA on Wednesday announced revised drug-labeling rules that will require drugmakers to provide additional information about the risks of taking medications during pregnancy or while breastfeeding, the New York Times reports (Tavernise, New York Times, 12/3).

The rules, which have been under consideration since 2008, will take effect in June 2015. According to the Washington Post's "To Your Health," they will apply to all biologics and new prescription medications, as well as drugs approved since 2001 that have not yet been updated to reflect risks for pregnant or breastfeeding women. The rules will not apply to over-the-counter drugs.

Current System Considered Confusing, Outdated

The current system has been in place since the 1970s and categorizes risk for pregnant and breastfeeding women as "A," "B," "C," "D" or "X" (Dennis, "To Your Health," Washington Post, 11/3). X-labeled drugs are considered the riskiest, the Times reports.

According to the Times, many physicians consider the current system confusing, outdated and vague. Specifically, physicians said that many drugs were categorized as "C," which meant that studies have demonstrated potential risk to the fetus in animal trials, but that no adequate studies have been conducted with human subjects.

Revised Labeling System

The new rule will require drugmakers to replace the letter system currently included in the information packet that comes with drugs with detailed summaries of risk information (New York Times, 12/3). The information will not be included on the pill bottle, but it will be included on drug labeling that physicians are supposed to review when making prescribing decisions (AP/Modern Healthcare, 11/3).

Drugmakers will be required to detail the risk assessment in three sections: pregnancy, breastfeeding and fertility (New York Times, 12/3). Each section will summarize patient risk and include data supporting those conclusions ("To Your Health," Washington Post, 12/3).

The summaries will specify whether the risks have been assessed through human or animal trials (AP/Modern Healthcare, 11/3). However, the rule will not require drugmakers to conduct studies on potential risks if no research is currently available (New York Times, 12/3).

According to AP/Modern Healthcare, older medications will be required to phase in the new labelling rules over the next few years (AP/Modern Healthcare, 11/3).


Sandra Kweder, deputy director of FDA's Office of New Drugs, said the current system "can be 'very difficult for physicians to make sense of'" (Devaney, The Hill, 12/3). By contrast, she said the new system "requires that more information about drugs will be provided than ever before, and in a manner that speaks directly to the concerns" of physicians and patients.

Kweder also said requiring drugmakers to include the information was a good first step, noting that such a requirement could help drive research (New York Times, 11/3). Drugmakers often "know about the information in the medical literature and they have chosen for whatever reason not to use it," she said.

The American College of Obstetricians and Gynecologists voiced support for the new requirements (The Hill, 12/3).