Modified on 2009/10/14 21:42 by admin
Updated 30 July, 2007

FDA Announces Restricted Access Program for Zelnorm

Use of Zelnorm will be permitted under a new restricted access program, approved by the FDA.  The drug was taken off the market in March because of a high risk of heart attack, stroke, and chest pain.  Zelnorm is being reintroduced because of complaints from doctors and their patients, who say that there is still a need for the drug.

The new program requires patients to meet certain requirements before they can use the drug.  Users can not have any past or present heart problems and must be in serious need of Zelnorm.  The drug may only be used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 years.  The drug will remain off the market for the general public.

The FDA decided that even with the increased risk of cardiovascular problems, Zelnorm may still benefit certain patients who have no other treatment options.

Updated 30 March, 2007

Zelnorm linked to Heart Problems and Stroke, Recalled by FDA

At the request of the US Food and Drug Administration, Zelnorm, an irritable bowel syndrome drug manufactured by Swiss drug maker Novartis AG, was recently recalled from the market.

Approved in 2002 by the FDA, this drug was later linked to statistically significant numbers of adverse side effects, including heart attacks, heart problems, strokes, and in one case, a death.

Prior to its recall from the US pharmaceutical market, Zelnorm was under prescription to about 500,000 people, and in 2006 alone brought over $488 million in revenues to Novartis. If you or a family member has suffered serious illness or injury as a result of using Zelnorm and would like to contact an attorneyto review your claim at no charge, you may do so using the form at the right.

Zelnorm, also known as Zelmac or tegaserod maleate, was previously indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Zelnorm increases the movement of stools through the bowels. The medication does not cure IBS, nor does it treat diarrhea-predominant IBS.

Zelnorm reduces pain and discomfort in the abdominal area, and eases soreness associated with bloating and constipation. The U.S. Food and Drug Administration (FDA) approved Zelnorm, made by Swiss pharmaceutical giant Novartis International, in July 2002. The FDA based its decision to approve Zelnorm on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks.

Side effects that occurred in patients during clinical trials included headaches and diarrhea. The safety and effectiveness of Zelnorm in men have not been established.

The approval of Zelnorm raised concerns among public interest groups who say the drug should not have been sold to patients. Critics, such as the interest group Public Citizen, cite the fact that several patients underwent surgeries for ovarian cysts after using Zelnorm during trials. An increase in gall bladder and other abdominal operations was also noted among Zelnorm users. The FDA chose not to approve the medication last year after health officials raised concerns over the drug's side effects. In July 2002, however, the FDA reversed its decision, saying the drug's link to abdominal surgeries was coincidental.

In April 2004, the FDA and Novartis notified healthcare professionals of an important drug warning and prescribing information for Zelnorm. This new information related to a warning for serious consequences of diarrhea and a precaution for rare reports of ischemic colitis in post marketing use of Zelnorm.

See your doctor if you have experienced serious side effects associated with Zelnorm. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Attorneys associated with InjuryBoard.com will evaluate your case free of charge. In addition, you will not pay any fees or costs unless your attorney recovers money for you. Please click on the free Ask An Attorney button or call 800 593 5446 to take advantage of this valuable service.

See Also

  1. Irritable Bowel Syndrome Drugs: Overview
  2. Diarrhea: Overview
  3. Headaches
  4. Ischemic Colitis Injury
  5. Liver & Gallbladder Disorders
  6. Ovarian Cysts: Overview
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