Serzone (Nefazodone) Risk Study
Dutch Board to Study Risks of Antidepressant Drug
By Andrew Conaway Reuters Health
AMSTERDAM (Reuters Health) - The Netherlands Medicine Assessments Board
announced that it will begin investigating the antidepressant drug nefazodone
after receiving reports of serious side effects from its use.
Since it became available in the Netherlands in 1994, the Medicine Assessment
Board has received 26 reports of serious liver failure and some deaths related
to the drug worldwide.
In the Netherlands there has been one reported case of liver failure, but no
deaths have been attributed to the drug, according to a spokesman for the
board, known as the College ter Beoordeling van Geneesmiddelen (CBG), in The
Hague.
Nefazodone, or nefazodon as it is known in the Netherlands, is manufactured by
the UK-based pharmaceutical company Bristol-Myers Squibb and is marketed here
under the brand name Dutonin. The drug is sold in the US as Serzone.
The drug has already been withdrawn from the Swedish market voluntarily by the
manufacturer, according to Dr. Pim van der Giesen of the CBG.
He added that the board had also considered pulling the drug from the market,
but that they had not decided to do so at this time, and no additional
advisories will be sent out to doctors. But he noted that the drug already
carries advisories and strong warnings on its use.
The Web site for the National Institutes of Health in the United States (www.nih.gov)
warns that nefazodone may cause "serious disease or damage in your liver" if
it is taken by anybody with liver problems.
A spokeswoman for Bristol-Myers Squibb in the Netherlands, Aglae Weyers,
confirmed that the drug is under investigation.
"We will cooperate fully with the CBG," said Weyers, "and will provide all
relevant details as needed concerning side effects of the drug."
She declined to comment further, citing the ongoing investigation.
Van der Giesen added that other European nations were aware of the Dutch
investigation.
"There are others in the EU member states who are watching with great interest
what we are doing," he said in a telephone interview with Reuters Health. "I
think there will be a lot of interest in this investigation."
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Last Updated on
02/20/2005
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