Zestoretic

Pregnant women who take angiotensin-converting enzyme (ACE) inhibitors, drugs used to treat high blood pressure, should consult their doctors about switching treatment. Using the drugs past the first three months of pregnancy could result in significant harm and even death to the fetus.

At FDA's request, the six U.S. companies that manufacture the drugs sent a letter in March to doctors emphasizing the risks when women in the second and third trimesters of pregnancy take ACE inhibitors. In addition, FDA announced that all ACE inhibitors would be required to carry a boxed warning on the label.

The companies that manufacture ACE inhibitors are Bristol-Myers Squibb (Capoten, Capozide, Monopril), CibaGeigy (Lotensin), Hoechst-Roussel Pharmaceuticals (Altace), ICI Pharmaceuticals Group (Zestril, Zestoretic), Merck Sharp & Dohme (Vasotec, Vasotec I.V., Vaseretic, Prinivil, Prinzide), and ParkeDavis (Accupril).

FDA's actions were prompted by continuing reports of fetal damage, including kidney failure and face or skull deformities, caused by these hypertension drugs. Although labeling for the products has for several years warned of the risks, more than 50 cases of fetal harm have been reported over the past several years.

In addition, very limited epidemiological evidence from Tennessee and Michigan Medicaid data bases indicates that fetal injury from exposure to ACE inhibitors in the second and third trimesters may be as high as 10 to 20 percent. FDA Commissioner David A. Kessler, M.D., noted, "The additional warnings will allow the safe use of ACE inhibitors by women who need them while helping to assure that women who become pregnant while taking these drugs promptly seek alternative treatment."

Pharmacists are being asked to counsel women of childbearing age who are taking ACE inhibitors about the risks and are being provided with warning stickers to place directly on the prescription bottles. Women taking ACE inhibitors who become pregnant should continue to take the medication because uncontrolled hypertension is dangerous to both mother and fetus, but they should consult their doctors immediately. There appears to be no risk to fetuses when the drugs are taken during the first trimester.

(For more information about ACE inhibitors, see "How to Take Your Medicine: Angiotensin-Converting Enzyme Inhibitors" in the May 1991 FDA Consumer.)

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