(Editor’s Note: On April 2, 2008, Zelnorm’s manufacturer voluntarily discontinued Zelnorm. It is no longer available.)
July 27, 2007 -- The irritable bowel syndrome drug Zelnorm, which was taken off the U.S. market earlier this year, will be allowed for some patients under tight restrictions, the FDA announced today.
On March 30, the FDA asked Novartis, Zelnorm's maker, to suspend Zelnorm's 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).
Today's FDA announcement doesn't mean that it's back to business as usual for Zelnorm.
Instead, the FDA is treating Zelnorm like an investigational new drug and restricting Zelnorm's use to the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," the FDA's Steven Galson, MD, MPH, says in an FDA news release.
"Zelnorm will remain off the market for general use," says Galson, who directs the FDA's Center for Drug Evaluation and Research.
Investigational new drugs aren't approved drugs.
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 investigational new drug protocol, when no comparable or satisfactory alternative drug or therapy is available.
When the FDA asked Novartis to take Zelnorm off the U.S. market in March, the FDA indicated that there might be patients for whom Zelnorm's benefits outweigh the risks and for whom no other treatment options were available.
At the time, the FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work resulted in today's announcement.
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% of those bowel movements: straining, hard stools, or incomplete evacuation of stools.
Doctors with IBS-C or CIC patients who meet the FDA's new criteria for treatment with Zelnorm should contact Novartis at (888) 669-6682 or (800) QUINTILE.
Those who do not qualify for the Zelnorm treatment protocol may contact FDA’s Division for Drug Information about other options at (888) 463-6332.