Zelnorm Recall
Zelnorm Recall?
At the request of the FDA, Novartis Pharmaceuticals agreed to issue a Zelnorm withdrawal on March 30, 2007, and halt marketing and sales of the popular irritable bowel syndrome (IBS) drug.
This action was sought by the FDA after it analyzed 29 clinical studies and found that patients were eight times more likely to suffer Zelnorm side effects than those given a placebo. 
The side effects of Zelnorm include heart attack, stroke, angina or other cardiovascular problems.
Concerns about Zelnorm
Some scientists had urged the FDA back in 2001 not to approve Zelnorm, believing that the risk of Zelnorm side effects was too high and that the drug did not work especially well.
Preliminary studies showed that Zelnorm users were five times more likely to require surgery to correct abdominal problems and three times as likely to develop ovarian cysts as patients who were given a placebo.
According to data from the FDA, Zelnorm is only about 6% more effective at treating the symptoms of IBS than a sugar pill. Despite the risk of Zelnorm side effects and its limited effectiveness at releiving the pain of IBS, the drug won approval the next year.
Novartis later conducted a routine safety review of the drug and found 13 cases of Zelnorm heart attacks and other cardiovascular problems among patients. The data showed that Zelnorm patients were eight times more likely to suffer heart problems than placebo patients.
Pulled from the market
Novartis reported these findings to the FDA in February 2007. Safety officials with the agency quickly began to assess the risk of Zelnorm side effects faced by patients who took the drug. The company was asked to issue a Zelnorm withdrawal on March 28.
A restricted future for Zelnorm?
The FDA says that Novartis is going to issue a complete Zenorm recall in the future due to the numerous side effects associated with the drug. So far, no date has been announced for the Zelnorm recall.
