WASHINGTON — Pregnant and worried about your medication? The Food and Drug Administration is revamping confusing labels on prescription drugs to make it easier to understand which are safe to use.
Women who are pregnant or breast-feeding often agonize over whether a drug needed for their own health might hurt their baby, or even if the woman’s changing body requires a higher or lower dose.
There are more than 6 million pregnancies in the U.S. every year, and FDA says women take an average of three to five prescription drugs during pregnancy. They may have a pregnancy-related infection or morning sickness. Or they may have an ongoing condition — asthma, diabetes, epilepsy or depression — that could dangerously worsen if they avoided treatment because of drug concerns.
Few medications have been fully studied to answer those questions, and what information is available is hard to tease out of the fine print on drug labels. The letters A, B, C, D and X are used to convey risk, but FDA admits that’s hugely misleading. A “B” drug might not really be safer than a “C” drug that just hasn’t been properly studied in people to tell.
Wednesday, FDA announced it’s scrapping those old labels. Starting next summer, labels on new prescription drugs must spell out, in a clearly designated section, what’s known about safe use during pregnancy or breastfeeding. Older drugs will phase in the new labels over the next three to five years.
“More information about drugs will be provided than ever before,” said Dr. Sandra Kweder of FDA’s Center for Drug Evaluation.
The information won’t be on small pill bottles. It’s required to be on the official drug labeling that doctors are supposed to read when deciding to prescribe, information that often is passed to consumers as package inserts at the pharmacy.
Nor does the new rule apply to over-the-counter medications.
Still, “this is a huge step forward,” said Dr. Christina Chambers of the University of California, San Diego, who works with the MotherToBaby hotline that counsels worried callers about medications during pregnancy.
Some medications do come with a lot of pregnancy information. Diclegis, for example, is the only drug to win FDA approval specifically to treat morning sickness. Doctors’ groups and the government recommend a flu shot for pregnant women, to protect themselves and because the baby is born with some of mom’s protection.
