US FDA Seems Ready For Return Of Zelnorm, But Seeks Advice On Best Subpopulation
Whether Sloan Pharma's irritable bowel constipation drug tegaserod should be indicated only for women at low cardiovascular risk, women who are severely symptomatic, or women who fall into both categories is a question for FDA's Gastrointestinal Drugs Advisory Committee; panel also is asked to discuss risk of psychiatric adverse events with the 5-HT4 receptor agonist.
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US FDA limiting use of Zelnorm, originally pulled from the market in 2007 by its then-sponsor Novartis, to adult women who are at low CV risk, but tegaserod is not restricted to patients who are severely symptomatic for IBS-C.
Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?
Seven advisory committee members said the treatment for irritable bowel syndrome with constipation should be labeled for females at low cardiovascular risk; three panelists, including two cardiologists, supported a narrower indication limited to low CV risk patients who also suffer from severe symptoms.