Zelnorm Intestinal Ischemia Warning

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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.

Our Experience - IBS Drug Litigation
Why You Should Choose Schmidt & Clark, LLP

“Our law firm has substantial expertise in the areas of gastrointestinal disorders such as IBS and the medications used to treat them."

Recently, the firm acted as lead counsel in the successful resolution of several hundred consumer claims involving the drug Lotronex® (alosetron), another IBS drug that was taken off the market because of serious side effects such as ischemic colitis (bleeding of the bowel) and bowel obstructions. Lotronex® was used to treat people with diarrhea-predominant IBS, but its pharmacology and mechanism of action is very similar to Zelnorm®. Both drugs act on a neurotransmitter substance called serotonin which effects numerous functions of the body, including “gut motility” (operation of the bowel), but also the brain and cardiovascular system.

Our attorneys are able to draw upon the pool of experience gained in Lotronex® and other products liability litigations to appropriately investigate, evaluate, and pursue potential Zelnorm® claims.

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Types of Zelnorm Side Effects we are Investigating

• Ischemic Colitis (acute or chronic)
• Intestinal Ischemia and/or Colonic Ischemia
• Heart Attack
• Stroke
• Angina Pectoris
• Dead Bowel
• Ulcerative Colitis
• Chron's Disease
• Serious Cardiovascular Injuries
• Serious Gastrointestinal Injuries

Do I have a Zelnorm Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Zelnorm lawsuits. We are handling individual litigation nationwide and currently accepting new Zelnorm cases in all 50 states.

Attention Attorneys: We do not publish prior verdict/settlements. If you are an attorney and would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.

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