THE CARDIAC PROBLEM WITH ZELMAC (ZELNORM)
In 2002, we received Zelmac (Tegasorod, Novartis), for use in patients with irritable bowel syndrome (IBS). It proved to be quite useful, especially in females. It was expensive and so the use was mainly in the richer group who could afford it. The standing joke amongst us was that zelmac was a rich women's laxative.
We did not know then that there was a CVS danger. I did use it in some of my richer patients and did not notice any CVS side effects. In this more elderly population, unless you have large population data, we could not tell. The data analysis found that 13 out of 11,614 patients (0.11%) demonstrated CVS events. The placeo group showed 1 out of 7031 patients (0.01%) demonstrating CVS events.
Over the weekend, when I was returning from a Beijing meeting, I read on the plane that Novartis had withdrawn the sale of Zelmac, at the request of FDA, in view of the reported higher rates of CVS events (such as angina, heart attacks and strokes). Apparently, when the drug was approved for use in 2002, the investigators, and FDA did notice a trend towards more angina in the treatment group. The trend did not reach significance, and so the drug was approved.
What we are seeing are the after-shocks from the VIOXX fiasco. The FDA appears to be very cautious and is looking very closely at clinical data. Recently, they did just that. The full database of the full 18,000 patients on Zelmac was looked into and they found that the trend towards more CVS events was true and reached statistical significance. MACCE were seen more often in the patients on Zelmac.
FDA will be holding a full public and advisory committee meeting on this findings soon, where, I believe post market survellience data will also be presented, to see if this adverse events were real. In the meantime, the FDA has requested Novartis to suspend the sale of the drug. Those are the facts. But I must say that this close scrutiny of drugs recently approved, has been a result of the fact that COX2 agents may have been released into the market too soon and proved to be harmful (at least Vioxx). I also think that Zelmac, once withdrawn, may not return to it's old glory. Novartis do not seemed too ruffled. In Malaysia, although Zelmac is a Novartis product, but I believe it has been given to a third party to market. I suppose that does tell us how strong Zelmac is in Malaysia.
We did not know then that there was a CVS danger. I did use it in some of my richer patients and did not notice any CVS side effects. In this more elderly population, unless you have large population data, we could not tell. The data analysis found that 13 out of 11,614 patients (0.11%) demonstrated CVS events. The placeo group showed 1 out of 7031 patients (0.01%) demonstrating CVS events.
Over the weekend, when I was returning from a Beijing meeting, I read on the plane that Novartis had withdrawn the sale of Zelmac, at the request of FDA, in view of the reported higher rates of CVS events (such as angina, heart attacks and strokes). Apparently, when the drug was approved for use in 2002, the investigators, and FDA did notice a trend towards more angina in the treatment group. The trend did not reach significance, and so the drug was approved.
What we are seeing are the after-shocks from the VIOXX fiasco. The FDA appears to be very cautious and is looking very closely at clinical data. Recently, they did just that. The full database of the full 18,000 patients on Zelmac was looked into and they found that the trend towards more CVS events was true and reached statistical significance. MACCE were seen more often in the patients on Zelmac.
FDA will be holding a full public and advisory committee meeting on this findings soon, where, I believe post market survellience data will also be presented, to see if this adverse events were real. In the meantime, the FDA has requested Novartis to suspend the sale of the drug. Those are the facts. But I must say that this close scrutiny of drugs recently approved, has been a result of the fact that COX2 agents may have been released into the market too soon and proved to be harmful (at least Vioxx). I also think that Zelmac, once withdrawn, may not return to it's old glory. Novartis do not seemed too ruffled. In Malaysia, although Zelmac is a Novartis product, but I believe it has been given to a third party to market. I suppose that does tell us how strong Zelmac is in Malaysia.
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