Paroxetine mesylate: comparable to paroxetine hydrochloride?
BACKGROUND
Currently available small case reports clearly propose that existing regulatory procedures to approve generic versions only require essential bioequivalence, have limitations and fail to meet stricter scientific and clinical demands.


METHODS
Data indicate that paroxetine mesylate has some potential differences in bio- and clinical equivalence compared with paroxetine hydrochloride, although it has not been fully and sufficiently investigated in well-designed clinical trials. Data available now regarding safety, tolerability, efficacy and practical issues dealing with debates between generic and brand-name products paroxetine mesylate and paroxetine hydrochloride are presented in the review.


RESULTS
Preclinical and clinical data are reviewed, and clinical issues relating to use of generic version versus original product are comprehensively discussed; tips for the clinician in clinical practice are also provided.


CONCLUSIONS
Potential differences in efficacy and safety but also reduction in the use of health care and in pharmacy cost should be considered when choosing the generic version or the original product based on the clear benefit-risk ratio in patients.
Pae
Chi-Un
CU
The Catholic University of Korea College of Medicine, Bucheon St Mary's Hospital, Department of Psychiatry, 2 Sosa-Dong, Wonmi-Gu, Bucheon Kyounggi-Do 420-717, South Korea. pae@catholic.ac.kr
Misra
Aayushman
A
Ham
Byung-Joo
BJ
Han
Changsu
C
Patkar
Ashwin A
AA
Masand
Prakash S
PS
D003257:Consumer Product Safety; D017281:Cost of Illness; D017277:Drug Approval / Q000191:economics / Q000379:methods*; D006801:Humans; D017374:Paroxetine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
D017374:Paroxetine