Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: SATURDAY, March 14, 1992 TAG: 9203140142 SECTION: NATIONAL/INTERNATIONAL PAGE: A-12 EDITION: METRO SOURCE: Los Angeles Times DATELINE: WASHINGTON LENGTH: Short
The agency decided not to ban the drug because it is valuable for many patients, and its risks are unique to pregnant women, FDA Commissioner David Kessler said.
At the FDA's request, the six pharmaceutical companies that manufacture the 13 drugs will alert physicians by letter that use of so-called angiotensin converting enzyme inhibitors, or ACE inhibitors, during the second or third trimester of pregnancy can result in face, skull and limb deformities, lung problems, kidney failure and even fetal death.
An estimated 6 million Americans take ACE inhibitors. Of these, about 5 percent are women under 40, according to Merck & Co. Inc., which makes five of the drugs. The company also said that about 5.5 million women in the United States between 18 and 44 suffer from high blood pressure.
by CNB