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ACE INHIBITOR LABELING WILL CARRY BOXED PREGNANCY WARNING

Executive Summary

ACE INHIBITOR LABELING WILL CARRY BOXED PREGNANCY WARNING as part of class-wide labeling changes outlined in a March 13 "Dear Health Care Professionals" letter from the six manufacturers of angiotensin-converting enzyme inhibitors to over 700,000 health care providers. FDA stated in a March 13 release that Bristol- Myers Squibb, Merck, Sharp & Dohme, Warner-Lambert, Ciba-Geigy, Hoechst-Roussel, and ICI are sending out the letter simultaneously "at the agency's request." Under the revisions, a boxed warning entitled "Use in Pregnancy" will be placed at the beginning of the labeling. The warning states: "When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, [trade name of the ACE] should be discontinued as soon as possible. See warnings: fetal/neonatal morbidity and mortality." The labeling sections entitled "Pregnancy," "Fetal/Neonatal Morbidity and Mortality" and "Information for Patients" will also contain more detail on the effects of the drugs in later-term pregnancies. The labeling changes will add to existing warnings in ACE labeling against the use of the drugs by women in the second and third trimesters of pregnancy. These warnings were first put into place in 1989, FDA said. FDA cited the fact that "more than 50 cases of fetal harm have been reported in the past several years" as the reason for the labeling change. In a separate statement, Merck said that "the warning is based on case reports conveyed directly to FDA and by industry." Merck said that notification of the labeling changes is being sent out in two forms. Approximately 201,000 obstetricians, endocrinologists, primary care physicians, cardiologists and nephrologists received the letter March 13 in the form of a mailgram. Another 500,000 professionals, including other physicians, pharmacists, nurses and physician's assistants, will receive the notice through the mail. Merck estimated that there are approximately six mil. Americans taking ACE inhibitors, of whom "an estimated 5% are women under 40." The changed labeling will state that "rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found." Even if an alternative cannot be found, the drug should be discontinued "unless it is considered life-saving for the mother."

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