Zelnorm Recall
June 20, 2001FDA denies approval for Zelnorm over side effects risk
The Food and Drug Administration has rejected a new drug to treat irritable bowel syndrome (IBS) over concerns that it raises the risk of abdominal problems. The agency says that more information is needed about the increased number of Zelnorm patients who have required gall bladder surgery before the drug can be approved.IBS is a condition which causes abdominal pain and either diarrhea or constipation. Zelnorm was designed to treat the constipation type of the disease. About 4.7 million Americans suffer from IBS, 70% of whom are women.
According to studies conducted by its manufacturer, Novartis Pharmaceuticals, of the risk of Zelnorm side effects, patients taking the IBS drug required surgery to correct gall bladder or other abdominal problems five times as often as those taking a placebo. Patients with IBS ordinarily require gall bladder surgery about as often as the general population.
Some medical experts believe that the FDA’s decision not to approve Zelnorm may be due to problems with another IBS drug, Lotronex, which took place last year. Lotronex was approved in February 2000, but was withdrawn less than a year later after several patients died from gastrointestinal problems after taking the drug.
Another reason for the FDA’s ruling could be the link between Zelnorm and ovarian cysts uncovered in Novartis’ clinical trials. Researchers found that patients taking Zelnorm were three times as likely to experience ovarian cysts as patients who were given a placebo.