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US FDA releases list of potential drug risks
Jun 05, 09 FDA warnings Medical Product Safety AlertsU.S. regulators released on Thursday a quarterly list of potential drug safety problems undergoing early review.
The medicines on the list include Pfizer Inc’s smoking-cessation drug Chantix for serious skin reactions, accidental injury and other issues, and Cephalon Inc’s sleep disorder drugs Nuvigil and Provigil for serious skin reactions.
The Food and Drug Administration said the problems were potential safety issues and their appearance on the list “does not mean that FDA has identified a causal relationship” with the drug.
The FDA posted the list on its website at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm161063.htm.
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