History of Zelnorm

Zelnorm was withdrawn from the U.S. market on March 30, 2007 because of safety concerns. Less than two months later, the Food and Drug Administration issued a public health advisory announcing that the drug’s maker—Novartis Pharmaceuticals—agreed to stop selling the drug. Zelnorm, however, has a history of problems dating as far back as March 2001 when Public Citizen, a consumer watchdog group, filed a petition to have the drug’s approval blocked. Since that time, Zelnorm has been linked to heart attack, stroke, chest pain and other serious health effects.

If you’ve suffered an adverse Zelnorm side effect, you should consult with an attorney as soon as possible to find out if you are eligible to financial reimbursement for your losses. Contact us today for a FREE case evaluation with a qualified product liability attorney.

FDA Regulatory Actions

July 24, 2002—FDA approves Zelnorm for short-term use in women who suffer from constipation-predominant irritable bowel syndrome (IBS).
April 2004—FDA updates Zelnorm’s labeling information to include a warning about the risk and consequences of severe diarrhea, including loss of consciousness, dehydration, and decreased blood pressure. At this time, a new precaution was added to the labeling about the risk of ischemic colitis (inflammation of the colon caused by decreased blood flow to the intestines).
August 2004—FDA approves Zelnorm for short-term use in women under the age of 65 suffering from chronic idiopathic constipation.
March 2007—FDA pulls Zelnorm from U.S. market after Novartis submits analyses of 29 short-term studies involving more than 18,000 patients found that Zelnorm users had a higher incidence of cardiovascular problems such as heart attack and stroke.

Reports of Adverse Events

Since 2002, the FDA has received 21 reports of Zelnorm users who experienced serious diarrhea and related effects, 20 reports of patients diagnosed with ischemic colitis, and three reports of other intestinal ischemia diagnoses. Some of these patients required hospitalization, others surgery, and some died.

According to the findings of Novartis’ extensive study analyses, at least one patient who suffered a Zelnorm-related cardiovascular event died compared with zero patients in the placebo control group.

Zelnorm Legal Help

If you’ve been harmed by Zelnorm, ensure your legal rights are protected by contacting an attorney today. You may be eligible to recover your losses through a Zelnorm lawsuit. Please click here to arrange a complimentary consultation with an experienced Zelnorm lawyer today.

Defective Drugs Breaking News

"Zelnorm Health Advisory"

The Food and Drug Administration (FDA) released a public health advisory on May 3, 2007, notifying healthcare professionals and patients that Zelnorm , a prescription drug used to treat...

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History of Zelnorm

Defective Drugs Breaking News

"Zelnorm Health Advisory"

Other Areas of Drug Recall