I appreciate the FDA's concern for public health. However, I am not sure how much I like FDA requesting manufacturers to remove drugs whose risks outweigh their benefits. I feel the decision to use a drug, regardless of the risk of adverse side effects, should be made by the clinician and patient. Every clinical situation is unique. Many of those patients on Zelnorm (or Vioxx, even) are very low risk for a cardiovascular event. (Zelnorm will still be available as an "investigational drug")
A friend of mine who is a gastroenterologist was annoyed at the decision since Zelnorm is a good, and often only effective, treatment choice for inflammatory bowel syndrome accompanied by constipation.
Patients treated with Zelnorm were 10x more likely to have a heart attack, stroke, or chest pain. But this was still only 13 out of 11,601 people. Good clinical judgment by the doctor should identify fairly easily a group of people that would be at risk for these adverse events.
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