Friday, May 25, 2007

Zelnorm Recall Site Launched

The law firm of Hissey Kientz, LLP has announced the launch of its new website, Zelnorm-Recall.com. This new site will provide patients with information about the potential health risks of Zelnorm, as well as medical and legal information concerning the recent recall of Zelnorm in the United States.

Zelnorm was designed to treat the symptoms of constipation associated with irritable bowel syndrome (IBS). Initially, the drug was rejected by the Food and Drug Administration due to a link between Zelnorm and abdominal problems, and its limited effectiveness at treating IBS. Zelnorm was eventually approved in July 2002, despite studies indicating an increased risk of ovarian cysts among Zelnorm patients.

After a routine safety review of Zelnorm in February 2007, the FDA was informed of clinical trial data concerning the drug which indicated that Zelnorm users were at an increased risk of cardiovascular side effects compared to patients treated with a placebo. Because of this risk, Zelnorm patients were about eight times more likely to suffer heart attack, stroke or other cardiovascular side effects.

Based on this information, Novartis Pharmaceuticals, the manufacturer of Zelnorm, withdrew the drug in the United States at the FDA's request. As a result, Zelnorm will no longer be sold or marketed in the United States. The FDA says that Novartis is planning to issue a full Zelnorm recall, although no date has been announced.

1 comment:

  1. Cool blog, i just randomly surfed in, but it sure was worth my time, will be back

    Deep Regards from the other side of the Moon

    Biby Cletus

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