Zelnorm is used to treat constipation, primarily in women with irritable bowel syndrome (IBS). At the request of the Food and Drug Administration (FDA), Novartis Pharmaceuticals Corporation, maker of Zelnorm, has agreed to stop selling the drug, due to an increased risk of heart attack, stroke, and chest pain.
In late February and early March, Novartis turned over the results of 29 studies on Zelnorm, to the FDA. The combined results were analyzed for the risk of side effects on the heart and blood vessels. The studies involved 18,645 patients. Of the 11,614 people who were given Zelnorm, four had a heart attack, three had a stroke, and six had dangerous chest pains, totaling 13 patients who experienced serious or life-threatening cardiovascular events. One of the heart attack victims died. Of the 7,031 who were given a placebo, only one had an adverse cardiovascular event, symptoms of a possible oncoming stroke which resolved without harm.
The FDA says the risk is small, but significant enough to warrant pulling the drug, at least temporarily. If Novartis can demonstrate that there is a group of people for whom the benefits outweigh the risks, the drug may be re-introduced on a limited basis.
Irritable bowel syndrome is a very common condition, accounting for more than 10% of all doctor visits, but it is something that people don’t like to talk about. The most common symptoms are:
- Abdominal pain
- Abdominal cramping
The exact cause of IBS is still unknown, but we do know that stress and certain foods can trigger an episode. To make matters worse, different foods cause problems for different people. The triggers are highly individual, and each IBS sufferer must figure out on their own, what he or she can and cannot eat. Hormones may also play a role. More women suffer from IBS than men, and many experience worse symptoms during or around the time of their periods.
IBS is a painful and debilitation condition, which is difficult to successfully treat. While dietary changes can be helpful, they are usually not enough to keep the symptoms at bay. Even with medication, most IBS sufferers have to be very careful about what they eat.
Zelnorm was approved for short term treatment of women with IBS and for chronic constipation in men and women under the age of 65. It addresses some of the symptoms of IBS, but not the condition itself. It relieves constipation by increasing the action of serotonin in the gut. Not all IBS sufferers experience constipation as a symptom, some experience severe diarrhea, and others have a combination of the two. Lotronex is used to treat IBS patients with severe diarrhea. It was pulled from the market in 2000, due to concerns about serious side effects, but reintroduced on a limited basis in 2002.
If you are taking Zelnorm or any other dangerous drug, you should talk to your doctor about alternatives, right away. You should seek immediate medical attention if you experience any symptoms of a heart attack or a stroke including:
- Shortness of breath
- Chest pain
- Difficulty walking
- Difficulty speaking
The harmful, potential side effects of Zelnorm include:
- Heart attack
- Severe and dangerous chest pains
- Ischemic colitis
- Intestinal ischemia
- Colonic ischemia
If you or a loved one has suffered health problems resulting in injury or death while taking Zelnorm, talk to an experienced pharmaceutical injury attorney today.