FDA to Make Drug Warning Labels Clearer for PregnantDec 5, 2014
The U.S. Food and Drug Administration (FDA) is improving the often-confusing drug warning labels to make information about use during pregnancy or breastfeeding clearer. CBS/AP reports that every year in the United States, there are over 6 million pregnancies. According to the FDA, pregnant women take an average of three to five prescription drugs over the course of their pregnancy.
Pregnant women may take medications for a pregnancy-related infection or morning sickness, or for a chronic condition such as asthma, diabetes, epilepsy or depression. With these ailments, stopping treatment could lead to serious consequences. On the other hand, pregnant women frequently worry that taking medications during pregnancy could have detrimental effects on their baby. Most medications have not been fully studied to determine their effects in pregnant and breastfeeding women.
The FDA acknowledges the fact that drug labels are confusing, CBS/AP reports. The information, written in fine print, uses the letters A, B, C, D and X to alert users about the potential dangers. The FDA announced on Wednesday that this system will no longer be used starting next summer. From that point on, labels on prescription drugs must clearly state information that is known about safely using the drug during pregnancy or breastfeeding. The new labels will also specify whether these risks have been studied in animals or humans. The new system will be phased in for older drugs over the next few years.
Dr. Sandra Kweder of FDA's Center for Drug Evaluation stated “More information about drugs will be provided than ever before,” CBS/ AP reported.
However, this information will not be printed on pill bottles themselves. It will be included in the official drug labeling that should be read by doctors when making decisions about which medications to prescribe. Consumers often get this information in the form of package inserts at the pharmacy. The revisions will also not include over-the-counter medications, although widely used drugs such as acetaminophen have been linked to a risk of attention deficit hyperactivity disorders.
“This is a much needed change and will provide patients and health care providers will specific and relevant information, including data drug trials and registries,” said Dr. Joanne Stone, director of Maternal Fetal Medicine at The Mount Sinai Hospital. She told CBS News that the categories that have been used up until now are not particularly helpful for informing patients about use during pregnancy or breastfeeding.
Cynthia Pellegrini is of March of Dimes, which has advocated for the change ever since the agency proposed it six years ago, CBS/AP reports. She says that the new labels are a start, because for many drugs, not much is known about how the impact on the reproductive system. “For a lot of drugs, the new labels will have little or no information to actually include,” Pellegrini said.