E-DRUG: Pemoline withdrawn in the U.K.

[srahmad@essential.org]

E-DRUG: Pemoline withdrawn in the U.K.
--------------------------------------

Dear E-druggers,

I just came to know about the website of the Medicine Control Agency 
(MCA)/Committee on Safety of Medicines (CSM) in the U.K. The URL is 
http://www.open.gov.uk. Once in the website double click on 
"Organizational index" and then on "M" and then on MCA. I think this 
site will be useful to many e-druggers.

I am reproducing below a news about the withdrawal of pemoline from 
the U.K. Those who have direct internet access can see the full text 
of the publication Current Problems on the above website. 

Pemoline is a central nervous stimulant indicated in attention 
deficit hyperactivity disorder (ADHD).

It is interesting to note that the decision in the U.K. was based
on cases reported in the U.S. However, to my knowledge pemoline has 
not been withdrawn in the U.S. However, the product labeling for 
pemoline (brand name Cylert in the U.S.) was modified to include a 
boxed warning describing liver failure and to indicate that pemoline 
should not ordinarily be considered as first-line drug therapy for 
attention deficit hyperactivity disorder (ADHD). 

E-druggers, could you please report the status of pemoline in your 
country? Thanks.

Syed Rizwanuddin Ahmad
E-drug moderator
Email: srahmad@essential.org

=====================================================================

Volital (Pemoline) has been withdrawn
Withdrawn because of serious hepatotoxicity

Pemoline (Volital), which was indicated for the treatment of 
hyperkinetic syndrome, is no longer generally available because of 
serious hepatotoxicity.

Despite limited usage, 33 serious hepatic reactions have been 
reported in the USA, leading to liver transplantation in 2 cases and
death in a further 6 cases.

The evidence for the efficacy of pemoline in the treatment of 
hyperkinetic syndrome is limited and there is no good evidence from
appropriate clinical trials that pemoline is effective in patients 
who have failed to respond to alternative drugs.

Since there is a significant risk of serious hepatic toxicity, which 
may prove fatal, the CSM considered that the risks of treatment with 
pemoline outweigh the benefits and the drug has therefore been 
withdrawn.

Source: Current Problems in Pharmacovigilance Vol 25 August 1997

--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to:  `owner-e-drug@usa.healthnet.org'.