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Teratogenicity of Most Recent Drugs Is Not Known

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http://www.medscape.com/viewarticle/440882?mpid=3425

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HomeCME CenterConference CenterLibraryDiscussionsMarketplaceHelp September 13, 2002  
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Teratogenicity of Most Recent Drugs Is Not Known


 

 


 

By Alison McCook

NEW YORK (Reuters Health) Sept 02 - More than 90% of drugs approved since 1980 have not been properly tested to rule out possible teratogenic effects, study findings show.

Animal testing is the first step to determine if a drug is a possible teratogen. After drug approval, careful follow-up studies are still needed to confirm the drug's safety.

However, Drs. J. M. Friedman and W. Y. Lo, from the University of British Columbia in Vancouver, Canada, found that for the vast majority of new drugs these follow-up studies have not been performed. As such, more than 90% of new drugs are still considered to have an "undetermined" risk of producing birth defects, according to the report in the September issue of Obstetrics & Gynecology.

"My experience is that many members of the general public, both pregnant women and their partners, are surprised and frustrated about how little we really know about the safety of medications in pregnancy," Dr. Friedman told Reuters Health.

The solution, Dr. Friedman said, is simply to keep track of what effects the drugs have in pregnant women who take them. "I would like to see an ongoing effort to obtain information about the effects on the baby of maternal use of prescription medications in human pregnancy," he added.

The authors base their findings on a review of information regarding the birth defect risk of 468 drugs approved between 1980 and 2000. They found that 91% of these new drugs were designated as carrying an "undetermined" risk of birth defects if taken by pregnant women.

Dr. Friedman said that the companies that manufacture the drugs often have no financial incentive to conduct further studies on birth defects once the drug is FDA-approved. Proper studies cost money, the researcher noted, and there is usually no regulatory requirement that the companies perform these tests.

Studies could follow a group of pregnant women and record what medications they take and the subsequent health of their infants, or interview parents of infants with birth defects and determine which medications the mothers took, Dr. Friedman suggested.

"The point is that such studies are possible, and I believe that they need to be done on a sufficient scale to learn about the safety of all medications in human pregnancy," he emphasized.

Obstet Gynecol 2002;100:465-473.

 

 

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Reuters Health Information 2002. © 2002 Reuters Ltd.
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