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Zelnorm (tegaserod maleate) was approved in 2002 by the U.S. Food and Drug Administration (FDA) to treat irritable bowel syndrome (IBS) and constipation by increasing the movement of stools through the bowels.
But then in March of 2007, the FDA asked Novartis, the drug’s manufacturer, to remove Zelnorm from the market in light of new evidence that it increases the risk of strokes, chest pain (including angina), heart attacks, and death. The evidence, in fact, suggested a tenfold increase in the risk of suffering a heart attack in patients who take Zelnorm compared with the general population.
By the time Novartis halted sales and distribution of Zelnorm, over half a million Americans had been prescribed the medication since its release. And in addition to the studies indicative of the serious cardiovascular risks, the FDA had received at least 20 reports of patients with ischemic colitis caused by Zelnorm, 3 reports of patients diagnosed with other kinds of intestinal ischemia, and 21 reports of patients suffering serious diarrhea.
Ischemic colitis is a reduced blood flow to the colon that in some cases can cause serious intestinal damage and in rare cases death. Intestinal ischemia occurs when part of the intestine dies due to the cutoff of blood supply and may require surgery and/or lead to sepsis (spread of infection to the blood stream), peritonitis (inflammation of the membrane that lines the wall of the abdomen), or death.
Because of the seriousness of the drug’s side effects, anyone who has taken Zelnorm and is suffering any of the symptoms associated with its side effects should consult with a physician as soon as possible and report any incidents to the FDA’s MedWatch program. Additional potential symptoms and side effects of Zelnorm include:
- Abdominal pain
- Difficulty speaking or understanding speech
- Feeling faint
- Heart pounding
- Loss of balance or coordination
- Lower back pain
- Rectal bleeding
- Sudden heavy sweating
- Sudden loss of vision
- Sudden paralysis, weakness, or reduced sensation
If you or a loved one has been injured as a result of having taken Zelnorm, you may wish to contact an experienced pharmaceutical injury attorney who can evaluate your case to determine if you are entitled to compensation. Protect your legal rights and options by contacting us today.