Six drug companies are warning women that a type of blood pressure medication could cause fetal deformities if taken in the latter stages of pregnancy, the Food and Drug Administration said Friday.
Labeling on the blood pressure medicine has warned of the hazards, but the FDA said it continued to get reports of deformities in fetuses whose mothers use the drug. The agency said it has received more than 50 such reports over the last several years.The medicine, known as an angiotensin converting enzyme - or ACE - inhibitor, is marketed under a variety of brand names.
At the FDA's request, the companies are putting a stronger warning on the label, saying that use of the drug "can cause injury and even death to the developing fetus." The companies also are sending a letter to doctors.
The fetal defects include kidney failure and face and skull deformities, the agency said.
The medication is used by some 6 million people in the United States, about 5 percent of whom are women under age 40, according to Merck Sharp & Dohme, one of the six manufacturers.