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How to request Zelnorm for Expanded Access use

How to request Zelnorm for Expanded Access use

Contact  

Division of Drug Information (DDI):
toll free at (855) 543-3784 or (301) 796-3400
email: druginfo@fda.hhs.gov

Background and Important Safety Information

Zelnorm (tegaserod maleate) is a 5-hydroxytryptamine 5-HT4 receptor partial agonist that enhances intestinal motility and stimulates intestinal secretion.  It is indicated for men and women with irritable bowel syndrome with constipation (IBS-C), and women under 55 with chronic idiopathic constipation (CIC).

In 2007, the Food and Drug Administration asked Novartis to suspend its United States marketing and sales voluntarily, because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm, compared with treatment with an inactive substance (placebo).   Marketing was voluntarily suspended in the United States.  The decision was based on a study of more than 11,600 patients treated with Zelnorm and over 7,000 patients treated with the placebo (see Related Information below).

Today, FDA authorizes the restricted use of Zelnorm through expanded access under a Single Patient IND (SPI).  US WorldMeds, LLC has agreed to continue to supply Zelnorm in these situations when no comparable or satisfactory alternative drug or therapy is available to the patient.   The following conditions are cause for denial of authorization:

  • prior history of heart attack or stroke
  • unstable angina
  • hypertension
  • hyperlipidemia
  • diabetes
  • age greater than 55 years
  • smoking
  • obesity
  • depression
  • anxiety
  • suicidal ideation

How to Get Zelnorm

Physicians

You can open a Single Patient IND (SPI) under the Expanded Access program in order to prescribe Zelnorm to a single patient who qualifies.  FDA generally responds to new SPI requests within a week.  Every effort will be made to meet your request for expedited review.  To submit an IND application for Zelnorm, please download the Zelnorm Single Patient IND Packet, which contains the required forms, instructions and patient questionnaire.  It also includes a list of answers to frequently asked questions.

Patients 

Please have your physician download the Zelnorm Single Patient IND Packet or contact DDI (above) to discuss Zelnorm.

Related Information

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