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Has anyone else heard that the FDA has discontinued...?
11-27-2012, 06:49 AM
Post: #1
Has anyone else heard that the FDA has discontinued...?
marketing the GI drug Zelnorm??? This is the best medicine I've ever had. I just very recently got put back on it. If this is true then does anyone know of a good alternative for it?? I accidently came across the FDA website when I was checking out the pet food recalls. If this was true, wouldn't we have heard something on the news about it since it's a very popular drug??

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons
The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndr

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11-27-2012, 06:58 AM
Post: #2
 
Yes your information is correct, here is an article on it:
A Novartis Drug Fails To Win F.D.A. Approval

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Published: June 19, 2001

Novartis, Europe's third-biggest drug maker, failed to win United States approval for Zelnorm, a new treatment for irritable bowel syndrome. Regulators questioned the medicine's safety.

Novartis, a Swiss drug maker, and its United States partner, Bristol-Myers Squibb, said they would keep fighting to win clearance for Zelnorm and are considering a formal appeal. Novartis's development head, Jörg Reinhardt, said the companies might also do additional studies.

Zelnorm, known as Zelmac in Europe, is one of five major drug introductions Novartis planned this year, and analysts had considered the group of developmental medicines to be among the industry's best.

The F.D.A.'s move is likely to delay any potential Zelnorm approval until at least 2003, investors said.

The announcement came after the Swiss market had closed. American depository receipts of Novartis, based in Basel, fell $1.84, or 4.8 percent, to $36.20; shares of Bristol-Myers Squibb fell 44 cents, to $55.06.
Novartis and Bristol-Myers had earlier pulled their European Union application for the treatment because European Union medical advisers questioned its effectiveness. Before, analysts had predicted Zelnorm would generate as much as $1 billion in annual sales.

The F.D.A. refused to approve the drug because of concerns about the number of Zelnorm patients who underwent abdominal operations. In the company's studies, patients taking the drug had a higher rate of such procedures than did patients on a placebo. Still, the difference did not reach the statistical threshold that regulators generally use to determine that an occurrence is not because of chance.

The agency mentioned concerns about the gall bladder surgeries only recently, and in last-minute conversations the F.D.A. rejected options like requiring marketing restrictions and warnings, Novartis said.

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11-27-2012, 06:58 AM
Post: #3
 
Information above is outdated - this is 2007 not 2001

The drugmaker Novartis is actually pulling off the market effective March 30th, 2007, at the urging of the FDA due to the life threatening cardiovascular problems the drug was causing.

See the most current information below from the FDA

As far as a replacment drug, you might want to talk to your Dr. about Lotronex (alosetron) - this drug was re-introduced to the market in 2002 - but is being used on a limited bases for IBS. For IBS patients who have a great deal of abdominal discomfort, mild anticholinergic antispasmodic drugs such as Bentyl (dicyclomine) or Levsin (hyoscyamine) can be helpful.
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