Novartis withdrawal of Zelnorm leaves patients scrambling

Novartis withdrawal of Zelnorm leaves patients scrambling
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First Published: Mon, Apr 09 2007. 07 29 PM IST
Updated: Mon, Apr 09 2007. 07 29 PM IST
Novartis AG’s decision to withdraw its Zelnorm irritable bowel treatment in the US last week because of side effects has left patients pondering their treatment options.
Zelnorm was the only drug for some patients with severe symptoms of the irritable bowel syndrome, doctors say. About 500,000 people in the US were taking the medicine, Basel, Switzerland-based Novartis said. The Food and Drug Administration asked Novartis last week to stop sales because a review of 18,000 patients indicated people taking the medicine had more heart attacks and strokes.
“Zelnorm was really the only effective and approved drug available for irritable bowel syndrome with constipation,” Roshini Rajapaksa, a gastroenterologist at New York University Medical Center, said in an e-mail. “Strokes and heart attacks are much more deadly than IBS, so it is appropriate to pull the drug.”
Some patients say the benefits associated with the treatment outweigh its heart risks. Joanne Miegel, 51, said she was “so miserable” before she took Zelnorm that a possible shorter life span is not “an issue” for her. The Boston resident has taken Zelnorm since it entered the market, and doesn’t yet know how she will treat the severe constipation associated with her condition.
Possible Return
Novartis Chief Executive Officer Daniel Vasella said 30 March that he didn’t know if the drug would be allowed return to the market. The product could have stayed on the market with a label change, he said. The patients taking sugar pills in the tests had an unexpectedly low rate of heart attacks, Vasella said.
Zelnorm brought in $488 million in the US in 2006. Sales were also halted in Canada, and Novartis is talking to health agencies in other countries. The drug will stay on the market in Switzerland.
Cathy Williams, who lives in Bentleyville, Pennsylvania, said she plans to contact her doctor to evaluate her options.
“I can only hope that my problems do not come back,” she said in an e-mail.
Zelnorm isn’t the first IBS drug to be pulled because of safety. GlaxoSmithKline Plc withdrew Lotronex in 2000 after the drug was linked to abdominal bleeding and deaths. In 2002, a US government panel backed the drug’s reintroduction, with tight restrictions on access to the medicine.
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First Published: Mon, Apr 09 2007. 07 29 PM IST
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