April 2008: Novartis Further Restricts Access To Its Constipation Drug Zelnorm

Zelnorm Now Available Only To Patients Who Require Hospitalization Because Their Condition Is Life-Threatening

In early April 2008 Novartis announced that it will further restrict access to its drug Zelnorm (tegaserod maleate), reserving it only for the sickest patients who have irritable bowel syndrome.

About a year before this action, in late March 2007, Novartis pulled Zelnorm from the U.S. market after clinical trial data suggested a possible link to heart attacks and strokes.

Next, in July 2007, Novartis began offering Zelnorm under a special program at no cost to treat irritable bowel syndrome (IBS) in certain women who also experienced constipation. In more detail, this program was a treatment investigational new drug application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55.

Now, under this new approach, according to this notice about Zelnorm posted on the FDA's web site:

FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use, or if exposure to Zelnorm would pose an unreasonable or a significant additional risk to patients.

Specifically, the FDA may deny permission for Zelnorm use where the patient has one or more of the following conditions:

• prior history of heart attack or stroke
• unstable angina
• hypertension
• hyperlipidemia
• diabetes
• age greater than 55 years
• smoking
• obesity
• depression
• anxiety
• suicidal ideation

Zelnorm is the only FDA-approved drug to treat patients with irritable bowel syndrome whose main symptom is constipation.

Irritable bowel syndrome affects the large intestine and causes a host of problems including bloating, abdominal cramping, diarrhea, and constipation.

Read more on our Zelnorm Information Page >>