其 他 安 全 警 示
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| The United States: Risk of birth defects cleft lip and cleft palate in babies born to mothers taking topiramates (English Only) |
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The U.S. Food and Drug Administration (FDA) informs the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Topamax was approved to treat certain types of seizures and also to prevent migraine headaches. FDA will give topiramate a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. Healthcare professionals should warn patients of childbearing age before prescribing topiramate about the potential hazard to the fetus if a woman becomes pregnant while using topiramate. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245594.htm
In Hong Kong, a total of 15 topiramate-containing products are registered. A topiramate-containing product is a prescription drug. In light of the new information, the issue will be discussed in the coming meeting of Registration Committee of the Pharmacy and Poisons Board. A “Dear Healthcare Professional” letter will be issued.
Ends/Saturday, March 5, 2011
Issued at HKT 12:00
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