RT Journal
A1 Kuehn BM
T1 CHallenge to alzheimer drug
JF JAMA
JO JAMA
YR 2012
FD December 26
VO 308
IS 24
SP 2557
OP 2557
DO 10.1001/jama.2012.156122
UL http://dx.doi.org/10.1001/jama.2012.156122
AB 
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.