I don't want to say too much about this until the smoke clears, but some early observations:
1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.
2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.
3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?
it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.
1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.
2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.
3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?
it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.
