收回的药物对女性威胁更大
http://www.100md.com
2001年2月9日
WASHINGTON (Reuters Health) - Of the 10 prescription drugs withdrawn from the market since 1997 because of adverse reactions, 8 posed greater risks for women than for men, according to a study by the General Accounting Office released Thursday.
``Four of these may have led to more (side effects) in women because they were prescribed more often to women than men, while the other four had more (side effects) in women even though they were widely prescribed to both women and men,'' said the study. The report was commissioned by a bipartisan group of House members and Senators.
The four drugs prescribed to women more frequently were the weight-loss drugs Pondimin and Redux, the diabetes drug Rezulin, and the inflammatory bowel disease drug Lotronex.
The four drugs prescribed equally to men and women but found more dangerous for women were the high blood pressure drug Posicor, antihistamines Seldane and Hismanal, and the heartburn drug Propulsid.
The other two drugs pulled from the market because of unacceptable risks--the antibiotic Raxar and the analgesic Duract--were no more dangerous for women than for men, the study found.
The lawmakers who commissioned the study said it shows that researchers and drug companies are still not taking seriously enough requirements imposed in 1992 that more women be included in clinical trials and drug studies.
``This finding shows serious and unacceptable cracks in the FDA (news - web sites) approval process,'' said Sen. Tom Harkin (D-IA). ``The agency clearly needs to do a better job of determining how drugs affect men and women differently. For some women, this can be a matter of life and death.''
Said Rep. Henry Waxman (D-CA), ``It is critical to discover sex-related variations before drugs are approved and in widespread use. Women need to be certain that when they take a prescription drug, it has been found to be safe and effective for them.''
The study is the first part of a broader look at how the 1992 requirements are being implemented. The rest of the report is due out in late April, according to Congressional staff., http://www.100md.com
``Four of these may have led to more (side effects) in women because they were prescribed more often to women than men, while the other four had more (side effects) in women even though they were widely prescribed to both women and men,'' said the study. The report was commissioned by a bipartisan group of House members and Senators.
The four drugs prescribed to women more frequently were the weight-loss drugs Pondimin and Redux, the diabetes drug Rezulin, and the inflammatory bowel disease drug Lotronex.
The four drugs prescribed equally to men and women but found more dangerous for women were the high blood pressure drug Posicor, antihistamines Seldane and Hismanal, and the heartburn drug Propulsid.
The other two drugs pulled from the market because of unacceptable risks--the antibiotic Raxar and the analgesic Duract--were no more dangerous for women than for men, the study found.
The lawmakers who commissioned the study said it shows that researchers and drug companies are still not taking seriously enough requirements imposed in 1992 that more women be included in clinical trials and drug studies.
``This finding shows serious and unacceptable cracks in the FDA (news - web sites) approval process,'' said Sen. Tom Harkin (D-IA). ``The agency clearly needs to do a better job of determining how drugs affect men and women differently. For some women, this can be a matter of life and death.''
Said Rep. Henry Waxman (D-CA), ``It is critical to discover sex-related variations before drugs are approved and in widespread use. Women need to be certain that when they take a prescription drug, it has been found to be safe and effective for them.''
The study is the first part of a broader look at how the 1992 requirements are being implemented. The rest of the report is due out in late April, according to Congressional staff., http://www.100md.com