Pregnant Women to Get Details of Drug Risks on U.S. Labels

Drug labels will be changed to detail the risks for pregnant women, ending a U.S. policy of indicating potential harm with a letter system that regulators said was confusing.

The Food and Drug Administration released a regulation today that will force drugmakers to explain to pregnant and lactating women the dangers of taking a medication. Current labels use the letters A, B, C, D and X for guidance. A medicine in the category X carries the most risk.

“We determined that the letter-category system had become too simplistic and more importantly was widely misinterpreted,” Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said during a call with reporters today.

Discussion of pregnancy is “probably one of the least-informative sections of drug labeling there is,” she said. Physicians relied heavily on the letters yet often didn’t understand the underlying information, the FDA said.

Removing the lettering system “is a large undertaking that will take several years,” the FDA said in a consumer update on its website. Newly approved drugs must comply with the new system by June 30 while those that are already on the market will be phased in over three to five years, Kweder said.

Industry Cost

It will cost as much as $78.2 million to comply with the new system, the FDA estimates. Companies won’t be forced to collect information on a drug’s risk to pregnant women, though if they don’t the medicine’s labeling will have to indicate the data isn’t available.

In developing the new labeling, the FDA did consumer surveys and consulted with drugmakers that were bringing new products to market to help them better inform patients of the risks before the regulation was made final.

New labels will summarize risk and detail relevant human and animal studies supporting the information. They will also include more information on whether medication gets into breast milk and how it could affect an infant and information for men and women of reproductive age on pregnancy testing, birth control and a drug’s effect on fertility.

A drug’s label includes the package insert where most information about the medicine is listed.

The FDA also released proposed guidance to help drugmakers comply with the new label standards.

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