2 Drugs pulled from market

[Guest guest]

Just in case any of you are on these drugs. It may well be that

Zelnorm has `only' been pulled in the USA:

Pergolide Withdrawn From US Market

from Heartwire — a professional news service of WebMD

March 29, 2007 — The manufacturers of pergolide in its brand-name

(Permax; Valeant Pharmaceuticals) and generic forms have agreed to

take it off the market after a pair of studies implicated the

dopamine agonist in causing serious heart valve damage, the US Food

and Drug Administration (FDA) has announced [1].

Two case control studies published in the January 4, 2007 issue of

the New England Journal of Medicine (NEJM) found significantly

increased rates of valvular dysfunction in patients with Parkinson's

disease taking pergolide and another dopamine agonist, cabergoline

[2,3]. As reported at the time by heartwire, the findings were

consistent with abundant clinical and mechanistic evidence that

activators of the serotonin receptor 5-hydroxytryptamine 2B (5-

HT2B), such as pergolide and cabergoline, cause a histologically

distinct form of fibrotic valvulopathy. Cabergoline is approved in

the US for the treatment of hyperprolactinemic disorders at doses

much lower and safer than those used in Parkinson's disease,

according to the FDA statement, which was published online today.

Those NEJM studies, along with the availability of other dopamine

agonists for Parkinson's disease, have led pergolide manufacturers

to withdraw the drug voluntarily, which will have a delayed effect

on pharmacy inventories, according to the FDA: " This delay will

allow time for healthcare professionals and patients to discuss

appropriate treatment options and to change treatments. "

Manufacturers of the generic products, the agency notes, include Par

Pharmaceutical Companies and Teva Pharmaceutical Industries.

The FDA recommends that patients currently taking pergolide contact

their healthcare providers to discuss alternative treatments but not

go off the drug on their own. Clinicians are urged to assess

alternatives and, if necessary, substitute another dopamine agonist;

others remaining on the market have not been linked to valve

disease. Current pergolide therapy should not be stopped abruptly

but should be gradually tapered, the agency cautions.

http://www.fda.gov/cder/drug/advisory/pergolide.htm

Schade R, Andersohn F, Suissa S, et al. Dopamine agonists and the

risk of cardiac-valve regurgitation. N Engl J Med 2007; 356:29-38.

Zanettini R, Antonini A, Gatto G, et al. Valvular heart disease and

the use of dopamine agonists for Parkinson's disease. N Engl J Med

2007; 356:39-46.

Novartis to Stop Constipation Drug Sale

By Associated Press

WASHINGTON - Swiss pharmaceutical maker Novartis AG will stop selling

a drug to relieve constipation after it was linked to higher chance of

heart attack, stroke and worsening heart chest pain that can become a

heart attack, federal health officials said Friday.

Novartis agreed to withdraw Zelnorm at the FDA's request, the agency

said in a public health advisory.

Zelnorm, also called tegaserod maleate, is a prescription medication

approved for short-term treatment of women with irritable bowel

syndrome with constipation and for patients younger than 65 with

chronic constipation, the FDA said.

Doctors who prescribe Zelnorm should work with their patients and

transition them to other therapies as appropriate, the FDA added.

Copyright 2007 The Associated Press. All rights reserved. This

material may not be published, broadcast, rewritten or redistributed.