Drug Label Information about Safety during Pregnancy to be Improved, FDA Says

Warning labels will be improved to more clearly state what is known about the safe use of a drug during pregnancy or breastfeeding, the U.S. Food and Drug Administration (FDA) announced.

Current drug labels are often confusing, the agency admits. The current system uses the letters A,B, C, D and X to relay the risks to patients. On Wednesday, the FDA announced that this system will no longer be used. Starting next summer, drug labels are required to clearly state what information is known about use during pregnancy or breastfeeding. The information will also state whether the studies were performed in animals or humans. Older medications will phase in this new label 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.

There are over 6 million pregnancies in the US each year, the FDA says. On average, pregnant women take three to five prescription drugs while they are pregnant. The drugs may be for reasons related to pregnancy, such as pregnancy-related infection or morning sickness, or for ongoing conditions such as asthma, diabetes, epilepsy or depression. Serious consequences can arise if pregnant women with these conditions stop taking these medication out of fear that they may hurt their baby.

However, few medications have been fully studied to determine its effects in pregnant and breastfeeding women.

The information will be included in the official drug labeling that should be ready by doctors when making decisions about which medications to prescribe, and not on the pill bottles themselves. Often this information is passed to consumers through package inserts obtained at the pharmacy.

Over-the-counter medications will not be affected by the new system, although common 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, of March of Dimes, says that the labels are a start since little is known about how many drugs affected the reproductive system. “For a lot of drugs, the new labels will have little or no information to actually include,” she told CBS.

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