Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater	 
Health Risks for Women (19-JAN-01, GAO-01-286R).		 
								 
The Food and Drug Administration (FDA) approves drugs for sale in
the United States when it determines that the clinical benefits  
of a drug outweigh its potential health risks. To make this	 
decision, FDA reviews supporting data collected from several	 
thousand patients during the drug's development. Once a drug is  
approved for marketing and used by potentially thousands of	 
patients, however, the type, rate, and severity of adverse events
caused by the drug can be much different than those seen during  
the drug's development. In some cases, FDA or drug manufacturers 
have removed from the market drugs that have been shown to have  
unacceptable health risks once they were in widespread use. GAO  
found that 10 prescription drugs have been withdrawn from the	 
U.S. market since January 1, 1997.  Eight of the 10 prescription 
drugs posed greater health risks for women than for men: four of 
these may have led to more adverse events in women because they  
were prescribed more often to women than to men, while the other 
four had more adverse events in women even though they were	 
widely prescribed to both men and women. Of the two remaining	 
withdrawn drugs, one belongs to a class of drugs known to pose a 
greater health risk for women, but GAO was unable to find direct 
evidence that the adverse events that contributed to its	 
withdrawal occurred predominantly in women. GAO found no evidence
that the health risks for the remaining withdrawn drug differed  
for women and men.						 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-01-286R					        
    ACCNO:   577746						        
  TITLE:     Drug Safety: Most Drugs Withdrawn in Recent Years Had    
             Greater Health Risks for Women                                   
     DATE:   01/19/2001 
  SUBJECT:   Consumer protection				 
	     Controlled substances				 
	     Drugs						 
	     Health hazards					 
	     Pharmacological research				 
	     Safety standards					 
	     Women						 
	     Health hazards