FDA proposes drug label changes to provide more information on risks for women who are pregnant, nursing

May 30 2008

FDA on Wednesday proposed changing its labeling system for prescription and over-the-counter drugs to provide more safety information for pregnant and breastfeeding women, the AP/Long Island Newsday reports (AP/Long Island Newsday, 5/28). On average, women in the U.S. take three to five medications when they are pregnant, and more than 90% of women who are breastfeeding take medications during the first week after delivery, USA Today reports.

Sandra Kweder, deputy director of FDA's Office of New Drugs, said that many physicians and patients are confused by the current system, which has been unchanged for 30 years (Szabo, USA Today, 5/29). The current system breaks drugs down into five categories: A, B, C, D and X, with Category A being the safest and Category X being known to harm human fetuses. Drugs in categories B, C and D all have varying levels of evidence showing risks and safety (AP/Long Island Newsday, 5/28).

Michael Greene, a Harvard Medical School professor and leader of an FDA advisory committee for the new system, said that people often assume all drugs in one category are equally safe, which is incorrect. He said the categories are very broad. About 60% of drugs fall into Category C, which includes treatments shown to cause harm to animals and those that have had no animal testing, according to FDA. Another issue with the current system is it offers "little help in assessing the risks to a baby who already has been exposed" to a drug the mother was taking before she learned of the pregnancy, according to USA Today (USA Today, 5/29).

Proposed System

Under the new system, which has been in development for 11 years, labels would outline research about risks, data on testing and other information (AP/Long Island Newsday, 5/28). Information in the new system would fall under three categories:

• Fetal Risk Summary, which would provide details about known risks and whether they were discovered in animal or human research;
• Clinical Considerations, which would explain drugs' effects if taken before a woman learned she is pregnant; and
• Data, which would outline research done in human and animal studies (Favole, Wall Street Journal, 5/29).

The labeling also would provide information such as whether pregnant women need to take a different dosage. In addition, it would provide background on general risk of birth defects to help put warnings into context (AP/Long Island Newsday, 5/28). The new labels also would detail the benefits of continuing treatment and how to manage side effects (Rockoff, Baltimore Sun, 5/29). The labeling would show risks of not treating conditions, as well, and how the effects change over time.

The new system also would require drug makers to update labels with new information about safety. Currently, drug makers only have to update labels about new warnings but not findings showing drugs are safer than originally thought. According to USA Today, drug makers have little incentive to make those labeling changes because updating labels is costly and takes time (USA Today, 5/29). If the proposal goes into effect, drug makers would immediately have to follow the new format for new drugs and those receiving revised labeling. For existing treatments, drug makers would have up to five years to change labeling to the new format.

The proposal is open to public comment for 90 days. FDA officials want to make the rule final within six months. "What we are looking for is to provide information in a way that is most useful and effective," FDA Commissioner Andrew von Eschenbach said (Baltimore Sun, 5/29).