Someone sent me the this link from NYT (registration). This answers the question posed in my previous post as to why Zelnorm was initially approved just in women. According to the article: "Men were dropped from the initial studies because the drug did not appear to work in them at all.". This leads me to wonder if the reason that the CV events were at a statistically insignificant level in the original label was because it was not studied enough in men? (given that for people below 65, men are more prone to CV events than women)? Once the drug was approved in men and more data in male patients became available, the CV events perhaps went up from insignificant to significant level.....just wondering.
Meanwhile ads from lawyers have started showing up!
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