After the request from Food and Drug Administration (FDA), drug giant Novartis Pharmaceuticals Corporation of East Hanover, New Jersey has withdrew Zelnorm from the market.
FDA’s this decision came after Novartis, the Swiss pharmaceutical company, itself revealed in a review that out of 11,614 patients who took Zelnorm, 13 suffered heart problems, including one death. On the other hand, in 7,031 patients who were prescribed placebos, just one patient suffered heart problem. Moreover, several other side effects have also been linked to Zelnorm.
Zelnorm was being prescribed, especially to treat irritable bowel syndrome, including multiple symptoms of abdominal pain, bloating and constipation. On the uses of Zelnorm, Dr. James Shannon, global head of development at Novartis himself avers:
Zelnorm provides unique benefit to patients by treating the multiple symptoms of abdominal pain, bloating and constipation that are associated with I.B.S. constipation.
But the good news for Novartis is that that FDA just wants to restrict access to Zelnorm partially so that patients who, physicians consider, should be provided with this drug may have access to it. FDA believes that patients,using Zelnorm should contact their health care providers to seek out its (Zelnorm’s) alternatives. Perhaps
that is the reason why Dr. Jenkins, director of the office of new drugs at the FDA said that the agency would work with Novartis to create a controlled system under which Zelnorm could be provided to patients whose physicians think that they must have it.
What is lying latent in the womb of future none knows, but one thing could easily be assessed that initiative taken by the FDA would come like a big bang on Novartis as just in the last year Zelnorm sale had skyrocketed up to $561 million.
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Via: NY Times