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Zelnorm® Ischemic Colitis Warning


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Please note, Schmidt & Clark, LLP is only accepting Zelnorm induced heart attack and stroke claims. If you feel that you may have a potential case with regards to Zelnorm induced ischemic colitis, we urge you to locate another law firm adequately suited to handle your claim.

The prescription medication Zelnorm (generically known as tegaserod maleate) is manufactured and marketed by Novartis Pharmaceuticals. It is commonly used to treat severe irritable bowel syndrome in women. The drug was approved in 2002 by the US Food and Drug Administration (FDA). Since Zelnorm’s initial marketing in the US, the FDA’s postmarketing adverse event reporting system has received numerous reports of serious adverse events experienced by patients taking Zelnorm, eventually leading to a Zelnorm recall. These adverse events included heart attack, stroke, intestinal ischemia, and ischemic colitis. In some of the patients affected, the events have led to hospitalization, surgery, and death.

What is Ischemic Colitis?

Ischemic colitis is a medical condition which results from a decreased blood flow to the intestines. This reduced blood flow can cause inflammation and injury to the large intestine, causing intestinal damage and in rare cases, killing the afflicted. Although this condition can be experienced in any part of the intestine, it usually manifests as a pain on the left side of the abdomen.

The most common symptom of ischemic colitis is new or worsening abdominal pain, tenderness, or cramping, usually located on the left side of the abdomen. The onset of this abdominal pain can be sudden or gradual. Other symptoms include fever, vomiting, bright red or maroon colored blood in the stool, diarrhea, and lower back pain.

In many cases, ischemic colitis is considered mild and resolves itself without medical intervention. Patients with mild to moderate ischemic colitis are treated with painkillers, IV fluids to ward off dehydration, and bowel rest until the symptoms are resolved. Severe cases of ischemic colitis can lead to serious complications and an immediate need for surgery. One complication associated with ischemic colitis is tissue death (gangrene) in the colon. The gangrene can develop 3 or 4 weeks after the initial reduction of blood flow to the intestine and can result in death if not treated in a timely manner. Ischemic colitis has also been known to result in a perforated bowel, which causes intestinal bleeding and may require surgery and intensive care to repair. Colon scarring due to ischemic colitis can cause chronic abdominal pain and blockage.

Based on the information reviewed by the FDA, the risks associated with taking Zelnorm was found to outweigh the benefits and a Zelnorm recall was issued by the manufacturer. The announcement was made on March 30, 2007, with the increased risk of adverse events cited as the major contributing factor. According to the manufacturer, Zelnorm will no longer be sold or marketed in the US, pending further discussions with the FDA.

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