PMID- 7593735
OWN - NLM
STAT- MEDLINE
DCOM- 19951212
LR  - 20190909
IS  - 0271-0749 (Print)
IS  - 0271-0749 (Linking)
VI  - 15
IP  - 4 Suppl 2
DP  - 1995 Aug
TI  - Moclobemide safety: monitoring a newly developed product in the 1990s.
PG  - 76S-83S
AB  - Moclobemide is a reversible and selective inhibitor of monoamine oxidase subtype 
      A with a wide spectrum of antidepressant activity. To fully evaluate product 
      safety, Roche Drug Safety has collected data on adverse events (AEs), regardless 
      of causality, from all sources worldwide through the product development phase 
      and after launch. This effort has included analyses of reports from clinical 
      trials, regulatory authorities, the literature, observational studies, and the 
      marketplace. Roche Drug Safety has also carefully examined all cases where 
      moclobemide was taken in overdose, whether with or without other substances. This 
      article presents the safety profile of the product after 3 years on world 
      markets. In clinical trials, moclobemide appeared only slightly less well 
      tolerated than placebo. In comparative trials, moclobemide was largely devoid of 
      the anticholinergic effects associated with tricyclic antidepressants. To the end 
      of June 1993, with an estimated 780,000 subjects exposed, AEs had been reported 
      by less than 0.2% of users. The most frequently reported AEs were psychiatric, 
      neurologic, and gastrointestinal disorders. Hepatobiliary AEs were rare, 
      suggesting that moclobemide is largely devoid of hepatotoxic potential. 
      Cardiovascular AEs reflected the prevalence of cardiovascular disease in the 
      population treated. This safety profile is largely unchanged from those observed 
      at 1 and 2 years postlaunch, when the estimated exposed populations were 168,000 
      and 328,000, respectively. It is of great significance that the fatal toxicity 
      index of moclobemide is zero. A review of single-drug intoxications with 
      moclobemide at doses of up to 20.55 g revealed no deaths due solely to 
      moclobemide overdose. All patients recovered fully within 1 to 7 days without 
      residual hepatic or cardiovascular toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)
FAU - Hilton, S
AU  - Hilton S
AD  - F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Jaber, B
AU  - Jaber B
FAU - Ruch, R
AU  - Ruch R
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Antidepressive Agents)
RN  - 0 (Benzamides)
RN  - PJ0Y7AZB63 (Moclobemide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/*adverse effects/poisoning/therapeutic use
MH  - Benzamides/*adverse effects/poisoning/therapeutic use
MH  - Depressive Disorder/*complications/drug therapy/psychology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Moclobemide
MH  - Product Surveillance, Postmarketing
RF  - 28
EDAT- 1995/08/01 00:00
MHDA- 1995/08/01 00:01
CRDT- 1995/08/01 00:00
PHST- 1995/08/01 00:00 [pubmed]
PHST- 1995/08/01 00:01 [medline]
PHST- 1995/08/01 00:00 [entrez]
AID - 10.1097/00004714-199508001-00013 [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 1995 Aug;15(4 Suppl 2):76S-83S. doi: 
      10.1097/00004714-199508001-00013.