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Zelnorm® Intestinal Ischemia 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 intestinal ischemia, we urge you to locate another law firm adequately suited to handle your claim.

Zelnorm (generic: tegaserod maleate) is a prescription medication marketed and manufactured by Novartis Pharmaceuticals. It is generally used to treat severe cases of irritable bowel syndrome in women. The medication received approval from the US Food and Drug Administration in 2002. Since the inception of Zelnorm’s marketing in the US, the postmarketing adverse event reporting system monitored by the FDA has received a number of reports linking Zelnorm usage to an increased risk of serious adverse events such as heart attack, stroke, ischemic colitis, and intestinal ischemia. Some of the patients affected have required hospitalization and surgery, some have even died. This information led to a Zelnorm recall in March of 2007.

What is Intestinal Ischemia?

Intestinal ischemia is a condition resulting from a diminished blood flow to the small intestine or colon. This condition can lead to ischemic colitis or more severe varieties of intestinal injury that may require surgery or result in death. The reduced blood flow to the small intestine or colon leaves the cells of the intestines without the proper amount of oxygen, causing the cells to become weak and die. As the amount of damaged cells grows, inflammation and ulcers can develop leading to an inability to absorb food and nutrients. If the damage is severe, it may develop into an infection and gangrene which, if left untreated, can be fatal.

There are two types of intestinal ischemia – acute and chronic. The symptoms of acute intestinal ischemia include frequent urgent bowel movements, abdominal tenderness, rectal bleeding, nausea, and sudden abdominal pain. Chronic intestinal ischemia is categorized by abdominal cramps that occur after eating and lasting up to three hours, unintended weight loss, nausea, bloating, and abdominal pain that worsens over weeks or months. Chronic intestinal ischemia can progress into the acute form of the condition.

Intestinal ischemia, though uncommon, is considered a serious medical condition requiring immediate medical care. The reduced blood flow to the intestine may result in the death of the intestinal tissue. When this occurs, surgery is needed to remove the portion of intestine that has died. After removing the damaged tissue, the surgeon will attempt to reconnect the healthy portions of the intestine. If this is not possible, the surgeon may need to perform an ostomy, in which a portion of the intestine is brought to the surface and connected to a bag to facilitate the elimination of waste. If left untreated, intestinal ischemia is often fatal.

As a result of the information reviewed by the FDA, it was determined that the risks of Zelnorm usage outweighed the benefits of the medication and a Zelnorm recall was issued by the manufacturer. Citing the increased risks of adverse events as the major reason for the Zelnorm recall, the manufacturer made the announcement on March 30, 2007. Zelnorm will no longer be sold or manufactured in the US pending further discussions between Novartis Pharmaceuticals and the FDA.

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