[e-drug] Nefazodone under investigation in the Netherlands

[e-drug@usa.healthnet.org]

E-drug: Nefazodone under investigation in the Netherlands
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Last Updated: 2002-11-18 16:42:02 -0400 (Reuters Health)
[Note: this antidepressant has now been withdrawn in Sweden-see 
below.  Copied as fair use.  BS]

By Andrew Conaway

AMSTERDAM (Reuters Health) - The Netherlands Medicine Assessments 
Board announced that it will begin investigating the anti-depressant 
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 (CBG) has received 26 reports of serious liver 
failure and, in some cases, deaths related to the drug worldwide.

In the Netherlands there has been one reported case of liver failure, 
but no deaths attributed to the drug, according to a spokesman for 
the CBG.

Nefazodone, or nefazodon as it is known in the Netherlands, is 
manufactured by the UK-based pharmaceutical company Bristol-Meyers 
Squibb and is marketed here under the brand name Dutonin.

The drug has already been withdrawn voluntarily from the Swedish 
market by the manufacturer, according to Dr. Pim van der Giesen, of 
the College ter Beoordeling van Geneesmiddelen (CBG), in The Hague.

He added that the board had also considered pulling the drug from the 
market, but that they had decided to not do so at this time, and no 
additional advisories will be sent out to doctors. But he noted that 
the drug already carries with it 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 patients with liver 
problems.

A spokeswoman for Bristol-Meyers Squibb in the Netherlands, Aglae 
Weyers, confirmed that the drug is under investigation.

"We will cooperate fully with the CBG," said Ms. Weyers, "and will 
provide all relevant details as needed concerning side effects of the 
drug." She declined to comment further, citing the ongoing 
investigation.

Dr. van der Giesen added that other member states were aware of the 
Dutch investigation. "There are others in the EU member states that 
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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