FDA Orders, Zelnorm Recalled

Zelnorm is an oral drug manufactured by Novartis for treatment of Irritable Bowel Syndrome (IBS) with constipation in women. Zelnorm was approved by U.S. Food and Drug Administration in 2002 for treatment of Irritable Bowel Syndrome. Later in 2004 it was also approved for the treatment of Chronic Idiopathic Constipation (CIC) in all the patients below 65 years of age. On 30th March 2007, FDA asked Novartis to recall Zelnorm from the market.

In 2005, around 2 million people in the U.S. were using Zelnorm for treatment of chronic constipation or irritable bowel syndrome. Previously in 2001 FDA has denied approval of Zelnorm on the ground of safety concerns. Later approval of Zelnorm by FDA was criticized but it was sold in large number till 2007. Around then reports of cardiovascular side effects of Zelnorm started pouring in. FDA also conducted a safety study. It conducted analysis of data, which was collected from 29 clinical trials and was involving over 18,000 patients. This study revealed its relation to cardiovascular problems. 11,614 patients were treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 years and around 88% were women. Study found an excessive number of serious cardiovascular problems occurring in patients, who used Zelnorm. These problems were angina, heart attacks and stroke.

On 30th March 2007, FDA asked Novartis to recall Zelnorm from the market. It requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily stop marketing of Zelnorm (tegaserod). This recall was a result of studies showing an increased risk of serious cardiovascular events associated with the use of Zelnorm. Novartis agreed to voluntarily postpone marketing of the drug in the United States.

FDA asked patients, who were using this drug, to consult their doctors about alternative treatment. They were asked to seek immediate medical help if they experience severe chest pain, symptoms akin to a heart attack or stroke, shortness of breath, dizziness, sudden weakness, difficulty walking, or talking. FDA concluded that risks from use of Zelnorm are more than it’s benefits.

On 27th July 2007 FDA permitted restricted use of Zelnorm in case of emergency, when there is no alternative available and use of this drug is essential for patient’s life. It was announced under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). It approved use of Zelnorm in some cases where its use is essential. It restricted its use in only women up to 55 years. It was allowed to be used when no comparable or satisfactory alternative drug or therapy is available. Other restriction was essentiality of use, which depended on doctor’s judgment. Patients were required to be fully informed about its risks.

FDA also asked Novartis to notify healthcare providers treating patients under the treatment IND protocol in writing. But further instances of its fatal side effects forced FDA to reconsider its decision of restricted use permission. Finally in 2009 FDA reversed its decision of restricted use permission given on 27th July 2007.

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