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Zelnorm Recall

The FDA approved Zelnorm to treat irritable bowel syndrome (IBS) in Zelnormwomen and chronic idiopathic constipation (CIC). Zelnorm, also known as Tegaserod, was manufactured and marketed by Novartis. Zelnorm was a popular drug in the United States but it was recalled after being linked to severe and even fatal side effects including:

FDA’s April 2004 Zelnorm Warning

From August 2002 through March 2004, the FDA received adverse event reports from Zelnorm users. The adverse reports included twenty-one patients with severe diarrhea, twenty patients with ischemic colitis, and three patients with other intestinal ischemia. The adverse events led to patient hospitalization, surgery, and death.

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On April 28, 2004, the FDA ordered Novartis to update Zelnorm’s label to include information about these risks but did not order a recall. The FDA announced that researchers will continue testing Zelnorm to determine if Zelnorm use causes these adverse events and whether a recall is warranted.

Novartis’ March 2007 Zelnorm Recall

On February 22, 2007, Novartis informed the FDA that studies linked Zelnorm use to severe cardiovascular problems. The studies involved 11,600 patients treated with Zelnorm and 7,000 patients treated with a placebo. The studies concluded that thirteen Zelnorm treated patients suffered a cardiovascular problem compared to only one placebo treated patient.

Based on the studies, the FDA asked Novartis to issue a recall of Zelnorm. On March 30, 2007, Novartis announced that it would recall Zelnorm in the United States.

FDA’s Partial Zelnorm Recall Repeal

On July 27, 2007, the FDA announced that it was partially repealing Zelnorm’s recall to permit its use under a treatment investigational new drug (IND) protocol. The IND protocol restricted Zelnorm use to treat IBS and CIC in women younger than 55 who met specific guidelines. Despite the recall, these women could use Zelnorm if:

  • Zelnorm benefits outweighed the risks
  • There were no other available treatment options
  • The women did not have any pre-existing cardiovascular problems

April 2008 Final Zelnorm Recall  

On April 2, 2008, Novartis announced that it intended to recall Zelnorm for IND treatment. The FDA confirmed that Novartis’ recall was voluntary and not in response to any FDA regulatory action. Novartis stated, however, it will continue to supply Zelnorm, despite the recall, in emergency situations.

Information on Zelnorm Recall

To arrange a free consultation with our experienced Zelnorm lawyers or receive more information about the recalls, please contact us today.



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Zelnorm Quick Facts

Zelnorm Quick Reference Guide
Other Names: 

Tegaserod

Date Approved:
2002

Manufacturer:
Novartis

Status:
Recalled (March 2007)

Approved Uses:
Irritable Bowel Syndrome (in women only)
Chronic Idiopathic Constipation

Serious Side Effects:
Angina
Heart Attacks
Stroke
Ischemic Colitis
Severe diarrhea

Common Misspellings:
Zellnorm
Zelnorn