TY  - JOUR
T1  - CHallenge to alzheimer drug
AU  - Kuehn BM
Y1  - 2012/12/26
N1  - 10.1001/jama.2012.156122
JO  - JAMA
SP  - 2557
EP  - 2557
VL  - 308
IS  - 24
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2012.156122
UR  - http://dx.doi.org/10.1001/jama.2012.156122
ER  -