FDA Recalls IBS Drug, Zelnorm®
WASHINGTON, DC — April 6, 2007 — Zelnorm®, a prescription drug used to treat irritable–bowel syndrome or IBS, was recalled last week because of its link to heart attacks and strokes. The Food and Drug Administration (FDA) requested Zelnorm®’s manufacturer, Novartis Pharmaceuticals, to take this action after receiving the company’s report about 29 clinical trials with over 18,000 participants. The pooled data showed that patients who took Zelnorm® were more likely to have heart attacks and strokes than patients who took a fake pill or placebo.
What Is IBS and How Was Zelnorm® Used?
Irritable–bowel syndrome or IBS is a condition in which the colon does not function properly. Zelnorm® (tegaserod maleate) was used to treat a form of IBS in women that results in stomach bloating, cramps and constipation. It was also prescribed for chronic constipation. Zelnorm® works by increasing the movement of fecal matter through the bowels.
What Should You Do If You Are Taking Zelnorm?
If you are currently taking Zelnorm®, the FDA recommends that you contact your doctor to discuss alternative treatments. You should seek immediate emergency medical care if you develop chest pain, shortness of breath, dizziness, sudden weakness or difficulty walking or talking. These could be symptoms of a heart attack or stroke.
Patients who used Zelnorm® should also consider their legal options. If you took this drug and had a heart attack or stroke, please feel free to contact us at Brayton Purcell for more information and a review of your potential case.
What Are Zelnorm®’s Side Effects?
In addition to increasing the risk of heart attacks and strokes, Zelnorm® may cause severe diarrhea, leading to dehydration, low blood pressure, fainting and hospitalization. Zelnorm® may also cause ischemic colitis, a condition resulting from reduced blood flow to the intestines. Ischemic colitis can cause intestinal damage and in some cases, even death.
Zelnorm® was first approved in July 2002. From the time that the medication went on the market until March 2004, the FDA received reports about 21 cases of severe diarrhea and dehydration, 20 cases of ischemic colitis, and 3 cases of other types of intestinal diseases. Some of these patients had to undergo surgery, and some died. In April 2004, the FDA changed the Zelnorm® labeling and prescribing instructions to warn patients about the risk of diarrhea and ischemic colitis.
Novartis Pharmaceuticals provided information to the FDA about the connection between Zelnorm® and increased heart attack and stroke rates in February of this year. The agency issued a Public Health Advisory late last month, and announced the Zelnorm® recall at that time.