Brand name(s): Zelnorm

Generic name: tegaserod

Preparations: tablet

Uses for IBS:
Zelnorm, or tegaserod, is a selective serotonin agonist used to treat constipation-predominant irritable bowel syndrome (IBS). Zelnorm currently is not available for general use, and is only available for emergency situations that are considered life-threatening or require hospitalization. Requests must be approved and shipments of the drug must be authorized by the FDA. Patients with certain risky conditions may still be denied in certain life-threatening situations, because of the high risk to benefit ratio. These conditions include: a prior history of myocardial infarction (MI) or stroke; unstable angina; hypertension; hyperlipidemia; diabetes; age greater than 55; smoking; anxiety; obesity; depression; and suicidal ideation.

Zelnorm was originally approved for the short-term treatment of women with constipation-predominant IBS because evidence showed that it was effective in treating abdominal pain, altered bowel habit, and bloating association with this condition. As a result of this treatment success, it received approval for chronic idiopathic constipation (CIC) in men and women less than 65 years of age. Zelnorm’s safety and efficacy in chronic constipation and IBS was demonstrated in long term studies (13 months), however additional safety studies demonstrated an increased rate in gallbladder surgeries in patients taking tegaserod versus those taking placebo. Subsequently, the FDA issued a non-approval letter to the manufacturer, Novartis, in June of 2001. Additional safety studies were completed and a new drug application was resubmitted to the FDA. Tegaserod was approved for use of constipation-predominant IBS in July 2002 and in August 2004, tegaserod was approved for CIC.

Results of another safety analysis showed patients treated with tergaserod had an increased rate of heart attack, stroke, and worsening heart-related chest pain compared to patients treated with placebo. In March 2007, Novartis agreed to the request of the FDA to halt sales, marketing, and distribution of tegaserod. In July 2007, it became available for use as a treatment investigative new drug (IND) protocol for IBS with constipation and CIC in women younger the 55 years old meeting specific guidelines; however in April 20008, Novartis announced that it would no longer provide tegaserod as a treatment IND. Tegaserod is now available for use only in emergency situations and clinicians wishing to prescribe it must contact the FDA for authorization.

Zelnorm is absolutely contraindicated in people who are hypersensitive to tegaserod and who have abdominal pain; colitis; gallbladder disease; hypotension; renal failure; syncope; or who are breast feeding. It should not be initiated in any patient who currently experiences or frequently experiences diarrhea. Precautions should be used in people with angina, anxiety, cardiac disease, depression, diabetes, GI bleeding, GI disease, liver disease, hyperlipidemia, hypertension, stroke, myocardial infarction (MI). Use in children should be avoided, because the safety and effectiveness has not been established in children below the age of 18. Pregnant women, especially in the first trimester, should avoid its use.

Adverse Effects
Tegaserod appears to be well tolerated; the primary adverse effects being abdominal pain, dyspepsia, flatulence, and nausea/vomiting. The expected diarrhea it produces is dose-related. Headaches and an increase in cardiovascular events such as chest pain (angina), has been reported.