Zelnorm Lawsuit

A Brief Guide to Filing a Zelnorm Lawsuit

What is Zelnorm?

Zelnorm, the brand name of Tegaserod, is a prescription medication used to relieve bloating, constipation and pain caused by Irritable Bowel Syndrome—a condition that causes constipation, diarrhea, bloating and stomach pain. Zelnorm is predominantly prescribed to women whose primary symptom is constipation; however, the medication is also administered to increase the frequency of bowel movements and relieve straining, stomach pain and bloating in men and women with chronic idiopathic constipation. Zelnorm belongs to a class of medications known as serotonin agonists; it is effective by improving muscle movement and increasing the production of fluid in the bowels.

Novartis, the maker of Zelnorm, recently notified the United States Food and Drug Administration that they will no longer sell Zelnorm to treat irritable bowel syndrome and chronic constipation in female patients below the age of 55. Novartis agreed to maintain supply for emergency situations only. Emergency situations are defined as events that pose life-threatening threats or are serious enough to qualify for immediate hospitalization.

Zelnorm Side Effects:

Zelnorm, like other prescription medications, yield numerous side effects. Please contact your doctor if any of these symptoms are persistent or particularly bothersome:

• Common Zelnorm Side Effects Include: Diarrhea; headache; nausea; bad gas; back or leg pain; joint problems; difficulty falling or staying asleep; runny nose; cold-like symptoms; and congestion

Some Zelnorm side effects may be more severe. If you experience any of the following symptoms labeled in the WARNING or SPECIAL PRECAUTIONS section, please contact your doctor immediately:

• Severe Zelnorm Side Effects Include: Hives; Itching; Rash; Swelling of the throat, tongue, lips, eyes or face; difficulty swallowing or breathing; and hoarseness.

Zelnorm: FDA Regulations History

On March 30th of 2007, the United States Food and Drug Administration asked Novartis to halt its U.S. marketing and sales of the drug because a safety analysis found an increased chance of stroke, heart attack and unstable angine (chest/heart pain) in patients using Zelnorm.

Only July 27th of 2007, the United States Food and Drug Administration permitted the restricted use of Zelnorm under a treatment investigational new drug program.

Zelnorm Legal History:

From the moment it was approved by the FDA to the time it was removed from the American market, the prescription medication Zelnorm faced an exorbitant amount of controversy. That being said, following its introduction in 2002, there was no significant Zelnorm lawsuit pursuing compensation related to adverse effects. Lack of Zelnorm lawsuits over the drug’s side effects continued through 2004, when a warning was added to reflect the increased chance of causing a condition that reduced blood flow from the large intestine. However, significant grounds for filing a Zelnorm lawsuit were not discovered until 2007.

In 2007, Novartis shared the results of multiple clinical trials concerning Zelnorm side effects. These studies found that 13 patients taking the drug suffered a heart attack—only one patient faced similar results under the placebo. The FDA concluded that Zelnorm side effects could be attributed towards the drug and requested that it be removed from the market. This removal sparked an influx of Zelnorm lawsuits.

Zelnorm lawsuits are filed by patients or the families of patients who were prescribed the drug, and as a result, developed the aforementioned Zelnorm side effects. That being said, a Zelnorm lawsuit will not award compensation merely for developing an adverse reaction following use. The ability to win a Zelnorm lawsuit revolves around the patient’s adherence to the drug’s intake instructions and an affirmed link between use and the development of Zelnorm side effects. If these two basic steps are achieved, a Zelnorm lawsuit will result in the delivery of compensation to the patient and/or his/her family. Zelnorm lawsuits provide a means to offset the costs associated with the development of severe adverse reactions: Zelnorm lawsuits provide compensation for medical costs, pain and suffering and lost wages due to missed work. To secure a settlement, your prospective Zelnorm lawsuit must be undertaken by a qualified

Following the drug's removal from the market, approximately 135 people filed a Zelnorm lawsuit. However, the results of these Zelnorm lawsuits have not been publicized. In 2010 Novartis announced that 124 people filing a Zelnorm lawsuit had received an out-of-court settlement. The company did not disclose the financial terms of these Zelnorm lawsuits.

At the time that the FDA announced the recall, it did not file a Zelnorm lawsuit against the manufacturer. Furthermore, the federal agency announced that it was willing to allow the drug to return to market at a later date if Novartis could identify a patient group for whom the benefits of taking the drug would be greater than the potential Zelnorm side effects. However, Novartis has not chosen to take advantage of this offer, thereby preventing itself from being the subject of any more Zelnorm lawsuits. Since the drug has not been available for 5 years, patients who are currently experiencing Zelnorm side effects probably will not be able to file an effective Zelnorm lawsuit at this time.

Sources:

1.The United States National Library of Medicine

“Tegaserod” retrieved from: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000251/

2. United States Food and Drug Administration

“Zelnorm Information” retrieved from:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103223.htm

3. FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons retrieved from:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108879.htm