Novartis’ Zelnorm pulled from market after safety concerns
pharmafile | April 2, 2007 | News story | Sales and Marketing |Â Â FDA, regÂ
Zelnorm, the treatment for irritable bowel syndrome, has been withdrawn from the US market after the FDA raised concerns about heart problems seen in some patients.
The drug's manufacturer, Novartis, has withdrawn it on the request of the US regulator, which had investigated the drug and found increased reports of cardiovascular problems.
The news is the latest sign that the US regulator is taking a more proactive approach to checking drug safety post-launch, following criticism of its failure to identify problems with Merck's Vioxx.
Merck's painkiller was withdrawn in September 2004 after it was linked to increased risk of heart attacks and strokes in patients.
A number of US patients have won court rulings linking their heart attacks with their use of Vioxx, but there is little suggestion so far that Novartis will face similar claims from Zelnorm patients.
The company has suspended the marketing, sales and distribution of Zelnorm to allow FDA Advisory Committee to determine the risks and benefits of this medicine.
Novartis says it still believes that the benefits of Zelnorm outweigh its risks, but this view is not shared by the FDA.
"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research.
"Here, a potential risk of very serious harm to patients, who have this non-life-threatening condition, was recently identified, making this action necessary."
Zelnorm was approved in the US in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation.
In August 2004, it gained a licence to treat chronic constipation for men and women under age 65 and is marketed in 55 countries worldwide.
Novartis will hope to eventually re-launch Zelnorm in the US, with extra warnings, safety monitoring or closer restrictions as to which patients can take the product safely.
Analysts Deutsche Bank say that around two-thirds of current US patients on Zelnorm have cardiovascular risk-factors, and forecasts that just 15% of current numbers of patients will be prescribed the drug after a re-launch.
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