E-DRUG: Diabetes drug withdrawn in the U.K.
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Troglitazone (Romozin) withdrawn
Serious hepatic reactions
Troglitazone (Romozin) is the first of a new class of orally active
anti-diabetic agents. It was launched in the United States and Japan
in March, and in the UK in October this year.
By early November, 40 cases of serious hepatic reactions occurring
during treatment with troglitazone had been reported worldwide. None
had originated in the UK. Reactions included severe hepatocellular
damage, hepatic necrosis and hepatic failure. One patient had died
and another required liver transplantation. GlaxoWellcome and Sankyo
Pharma, the companies marketing troglitazone in the UK, wrote to
doctors and pharmacists warning about these reactions and providing
advice about monitoring liver function tests.
We have now become aware of over 130 cases (6 fatal) worldwide of
hepatic reactions to troglitazone. The average time to the onset of
the reaction was 3 months (range 2 weeks to 8 months). In the UK,
some 5,000 patients have been treated with one reported case of liver
dysfunction. At present no clear risk factors for the development of
hepatic reactions have been identified which might allow the drug to
be used safely in some patients. The frequency of these reactions is
currently unclear. Approximately 370,000 patients worldwide have
been treated with the drug for at least 3 months.
Overall, it is considered that, based on present information, the
risks of troglitazone therapy outweigh the potential benefits. It has
therefore been voluntarily withdrawn from the UK as from 1 December
1997 by the companies concerned, who have informed doctors and
pharmacists by letter. Any patient who is taking troglitazone should
be transferred to an alternative therapy for the treatment of their
diabetes.
The product is being recalled on 1 December by the companies concerned.
For further information regarding the recall contact the companies on
0800 221441. Source: Medicine Control Agency (U.K.)
Note from the moderator:
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According to the Lancet (Dec 06 1997), about 600,000 U.S. and 200,000
Japanese patients with type 2 diabetes have been prescribed
troglitazone since March 1997, plus a further 5000 in the U.K. since
its launch there in October. Troglitazone has been one of the fastest-
selling drugs in history, with sales estimated at US dollars 137.00
million in the 3 months to October.
Syed Rizwanuddin Ahmad
Email: srahmad@essential.org
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