Bethesda, MD – The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines. 

In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.

In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.

On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).

At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.

"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, MD, MPH, director of FDA's Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."

Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.

Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.



We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Prescription Stomach Pills Could be Hurting You

This year the Federal Drug Administration (FDA) asked major drug manufacturer Novartis to voluntarily...

Restricted Use of Zelnorm for Qualifying Patients

The U.S. FDA announced that it is permitting the restricted use of Zelnorm under a treatment...

Zelnorm Back on the Market

The drug Zelnorm, manufactured by Novatis, was taken of the market in March because of a high risk of...

Opioid overdoses decrease American life expectancy for...

It’s been called an epidemic and a national health emergency, and it has probably affected someone you...

More than 6,000 lawsuits pending in MDL against...

The U.S. Judicial Panel on Multidistrict Litigation reports that there are now 6,121 lawsuits in a...
Risperdal Side Effects

Risperdal plaintiff granted retrial against J&J,...

Like thousands of other plaintiffs, W.C. alleges the defendants didn’t adequately warn about the risk...

Number one firm

I really appreciate the law firm, they look into every detail, they review everything with you not just once but several times to make sure everything is correct. They are a very good law firm and I would highly recommend them. They'll always call you back when you call with questions. They're number one in my book.

—Melva