Zelnorm Recall
March 30, 2007Consumer group warned of Zelnorm side effects risk in 2001
A consumer advocacy group says that the Food and Drug Administration should have never approved the irritable bowel syndrome (IBS) drug Zelnorm. Public Citizen says that it warned of the risk of Zelnorm side effects in 2001, including ovarian cysts, fainting and heart problems. Zelnorm was withdrawn by Novartis Pharmaceuticals at the FDA’s request this week because of its increased risk of causing heart attack and stroke.In a March 2001 letter to the FDA, Public Citizen warned the agency not to approve Zelnorm because of its marginal effectiveness and potential for causing health problems. Studies conducted by Novartis showed that Zelnorm was only 5 to 10% more effective at treating IBS than a placebo. Public Citizen also said that Zelnorm increased the risk of developing ovarian cysts and raised the risk of fainting to five times that of a placebo.
The group compared the risk of Zelnorm side effects with that of another gastrointestinal drug, Propulsid, which was recalled because of its link to cardiac arrhythmia. Propulsid was also associated with increased rates of fainting before its more serious side effects were recognized. Public Citizen said in its letter that the stomach receptors with which both drugs interact are also found in the heart, accounting for the increased rate of the cardiovascular side effects of Zelnorm.
The FDA asked Novartis to withdraw Zelnorm from the market on March 28 after the company’s studies showed that there were eight times as many cases of heart attack or stroke among patients taking Zelnorm compared with those taking a placebo. The FDA says that Novartis is planning to issue a Zelnorm recall, although no date has been announced.