Zelnorm Recall
Zelnorm Studies
At the request of the Food and Drug Administration, Zelnorm was withdrawn in the United States by Novartis after studies revealed that it caused an increased risk of cardiovascular side effects.
These 29 studies looked at 11,600 patients treated with Zelnorm and 7,000 more who were given a placebo. The studies found that patients treated with Zelnorm were about eight times as likely to suffer a heart attack, stroke or other cardiovascular problems as patients in the placebo group.
Zelnorm withdrawn
Based on this information, the FDA concluded that the risk of Zelnorm side effects was too great to allow the drug to remain on the market. On March 28, 2007, it asked Novartis to issue a Zelnorm withdrawal, and shortly afterward, the company complied. The FDA says that Novartis is planning to issue a Zelnorm recall, although no date has been announced.
Although knowledge of the cardiovascular side effects of Zelnorm has only emerged recently, earlier studies have linked the drug with a number of other dangerous conditions.
Preliminary review not encouraging
In June 2000, a preliminary review of Zelnorm studies by the FDA found that women taking Zelnorm were three times as likely to suffer ovarian cysts as those who were given a placebo. Many of these women were hospitalized and required surgery due to their Zelnorm side effects. As a result, the FDA rejected Zelnorm in July 2001 due to the health risks of the drug.
The FDA says that it received 21 reports of Zelnorm patients who suffered diarrhea so severe that it caused low blood pressure and fainting. The agency received an additional 20 reports of patients who suffered ischemic colitis (colon inflammation) after taking Zelnorm. Fourteen of these patients were later hospitalized, and four died.
Because a full understanding of the side effects of Zelnorm is only beginning to emerge, the total number of Zelnorm deaths is currently unknown. Many patients who were injured because of Zelnorm side effects may still be unaware that their injuries were caused by the drug.
