The US Food and Drug Administration (FDA) is keeping an Alzheimer drug on the market despite concerns about its safety and efficacy.
The agency turned down a petition to remove donepezil 23, a higher-dose (23-mg) version of donepezil, which recently became available as a generic in 5-mg and 10-mg doses. The petition, submitted by Public Citizen in May 2011, argued that the drug does not provide enough benefits to patients to outweigh the increased adverse events associated with it. Of particular concern was an increase in vomiting, which can lead to serious complications in this patient group. Public Citizen filed a lawsuit against the FDA in September after not getting a response from the agency; in November, the agency rejected the petition.
Kuehn BM. Challenge to Alzheimer Drug. JAMA. 2012;308(24):2557. doi:10.1001/jama.2012.156122
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