FDA Announces Warning to Pregnant Women on all Angiotensin Converting Enzyme

News 03/13/1992 FDA Announces Warning to Pregnant Women on all Angiotensin Converting Enzyme
(ACE Inhibitors)


P92-8                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Eva Kemper -- (301) 443-3285

    The Food and Drug Administration today announced that all angiotensin     
converting enzyme (ACE) inhibitors, a widely used group of antihypertensive   
drugs, will be required to carry a "boxed warning" on the label for women in  
the advanced stages of pregnancy.
    At the agency's request, six pharmaceutical companies are simultaneously  
sending out a "Dear Doctor" letter emphasizing that women who take the drug   
in the second and third trimesters of pregnancy are running the risk of       
causing significant harm to fetuses, including kidney failure and face or     
skull deformities.
    Labeling for these products has for several years warned of these risks,  
but additional cases continue to be reported.  More than 50 cases of fetal    
harm have been reported over the past several years.  The warnings in the     
labeling are therefore being strengthened by including a boxed warning and    
other changes.
    FDA Commissioner David A. Kessler, M.D., said, "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."
    No risk to fetuses appears to arise from exposure to ACE inhibitors that  
is limited to the first trimester.  Women who become pregnant while           
receiving an ACE inhibitor should not stop treatment on their own, because 
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                                            Page 2, P92-8, ACE inhibitors
uncontrolled hypertension is dangerous to them and their fetuses.  They       
should, however, consult their physician immediately.
    Pharmacists will also be alerted to this labeling change and will be      
asked to counsel women of child bearing age who are taking ACE inhibitors.    
They will also be provided with stickers that read, "If you become pregnant   
consult your doctor promptly about switching to a different drug," to be      
placed directly on the prescription bottles.
    The companies that manufacture ACE inhibitors and are sending out the     
"Dear Doctor" letter are Bristol-Myers Squibb (Capoten, Capozide, Monopril),  
Ciba-Geigy (Lotensin), Hoechst-Roussel Pharmaceuticals (Altace), ICI          
Pharmaceuticals Group (Zestril, Zestoretic), Merck Sharp and Dohme (Vasotec,  
Vasotec I.V., Vaseretic, Prinivil, Prinzide), and Parke-Davis (Accupril).
    FDA is one of the eight Public Health Service agencies within HHS.
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