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Published on Jul 27, 2007 by Edgar Snyder

IBS Drug Zelnorm Returns with Prescription Restrictions


The dangerous drug Zelnorm has been allowed to return to market for restricted use by women less than 55 years of age suffering from irritable bowel syndrome (IBS) with constipation and chronic idiopathic constipation. The Food and Drug Administration (FDA) has permitted limited prescriptions of Zelnorm under their investigational new drug (IND) protocol, often used for serious or life threatening conditions.

Since no comparable treatment currently exists, Zelnorm will be allowed limited use under guidelines known as treatment IND. Adhering to treatment IND rules means that the age, gender, and condition requirements set forth by the FDA must be strictly followed by healthcare professionals when prescribing the medication.

Zelnorm’s marketing and sales were suspended by the FDA earlier this year when the drug was linked to heart attack, stroke, and chest pain. At that time, the FDA announced it would consider a solution similar to its IND protocol. The IBS drug will continue to remain off the market for general use.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Maryland, Ohio, and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

Source: "FDA Permits Restricted Use of Zelnorm for Qualifying Patients." FDA Press Release. July 27, 2007.
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