Earlier today, FDA officials issued a public health advisory announcing that Novartis Pharmaceuticals Corp. has complied with an FDA request (PDF file: 4 pages / 94 KB. More about PDFs.) to immediately cease all U.S. sales and marketing of its prescription drug tegaserod maleate, sold as Zelnorm.
FDA Requests Withdrawal
Novartis Pulls Zelnorm From U.S. Market
By News Staff
3/30/2007
The drug is being taken off the market because a recently completed safety analysis found an increased risk of certain cardiovascular events, including myocardial infarction, stroke and unstable angina pectoris, in patients who took the drug. That analysis pooled the results of 29 short-term, randomized, placebo-controlled clinical trials involving more than 18,000 patients.
"While the overall number of serious cardiovascular adverse events reported was small, patients treated with Zelnorm were more likely to have these adverse events than patients treated with placebo," says an online questions-and-answers document on the FDA Web site.
"FDA has concluded, based on these data, that the benefits of this drug no longer outweigh the risks," says the FDA site. "After completing its review of these data, FDA asked Novartis on March 28, 2007, to discontinue marketing of Zelnorm."
The FDA first approved tegaserod in 2002 for the short-term treatment of women with irritable bowel syndrome with constipation. The agency later approved an additional indication for the drug, allowing its use in patients younger than age 65 with chronic idiopathic constipation.
In a letter being sent today to all health care professionals, Novartis states that the company soon will be contacting prescribers "to arrange for the return of any product samples and vouchers ... Patients can return unused and unexpired Zelnorm tablets and Novartis will reimburse them for their out-of-pocket costs."
For information on how and where to send unused and unexpired product, patients are asked to contact the Novartis Customer Interaction Center at (888) NOW-NOVA [669-6682].
"While the overall number of serious cardiovascular adverse events reported was small, patients treated with Zelnorm were more likely to have these adverse events than patients treated with placebo," says an online questions-and-answers document on the FDA Web site.
"FDA has concluded, based on these data, that the benefits of this drug no longer outweigh the risks," says the FDA site. "After completing its review of these data, FDA asked Novartis on March 28, 2007, to discontinue marketing of Zelnorm."
The FDA first approved tegaserod in 2002 for the short-term treatment of women with irritable bowel syndrome with constipation. The agency later approved an additional indication for the drug, allowing its use in patients younger than age 65 with chronic idiopathic constipation.
In a letter being sent today to all health care professionals, Novartis states that the company soon will be contacting prescribers "to arrange for the return of any product samples and vouchers ... Patients can return unused and unexpired Zelnorm tablets and Novartis will reimburse them for their out-of-pocket costs."
For information on how and where to send unused and unexpired product, patients are asked to contact the Novartis Customer Interaction Center at (888) NOW-NOVA [669-6682].
