E-DRUG: Drug Alert: Pemoline withdrawn in Canada
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Attention deficit drug withdrawn in Canada
NEW YORK, Sep 23 (Reuters Health) -- Cylert (pemoline), a drug used to
treat attention deficit hyperactivity disorder (ADHD) in children and
adults, is being withdrawn in Canada due to a ``rare possibility'' of
serious liver complications, according to Abbott Laboratories (NYSE:ABT
- news).
Canadian health authorities advised patients on Wednesday that they
should contact their physicians to discuss alternative treatments but
stressed that patients should not stop taking the drug until they
discuss treatment with their physicians.
According to Health Canada, the drug will continue to be available with
restrictions through Canada's Special Access Programme. Regulatory
authorities said that they would continue to evaluate new safety data
from the program and from reports worldwide.
There have been 16 cases of severe adverse liver effects reported
worldwide that might be associated with use of Cylert. Abbott and
Canadian authorities have issued a letter to physicians and pharmacists
to inform them of the withdrawal, which they intend to complete on
September 30. In addition, they noted that in patients taking the drug,
liver complications might not become evident for months and urged
physicians to continue monitoring liver function of patients who receive
the drug through the special access program.
An Abbott spokeswoman told Reuters Health on Thursday that Canada is the
only country in which the drug is being recalled. She said that the
company had discussed the issue with the US Food and Drug Administration
earlier this year and changed the labeling of Cylert to add a
recommendation of liver monitoring. The North Chicago, Illinois-based
company also issued a letter to approximately 150,000 physicians in the
US informing them of the label changes.
The spokeswoman said that the 16 cases are the total number of suspected
cases linked to adverse liver effects since the drug went on the market
in 1975. She declined to give sales figures for Cylert.
In Thursday morning trading, shares in Abbott dropped 3/4 to 41-1/2.
[Editorial note: Pemoline was withdrawn from the U.K. market two years
ago. Visit E-DRUG archives (www.healthnet.org/programs/edrug) for
details. Syed Rizwanuddin Ahmad, srahmad@essential.org]
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