Vioxx gained full FDA approval in 1999.
After 80 million people took it, in September 2004, five years later, it became clear it was causing heart attacks and strokes.
After 80 million people took it, in September 2004, five years later, it became clear it was causing heart attacks and strokes.
In 2009, ten years after FDA approval, Scott Reuben admitted that data from 21 efficacy studies was fabricated.
Between 2006 and 2011, hundreds of millions of dollars were paid out in civil suits, including wrongful death suits.
Between 2006 and 2011, hundreds of millions of dollars were paid out in civil suits, including wrongful death suits.
In 2015, the FDA reiterated its own conclusion that there is no specific risk of Vioxx but rather all NSAIDs have the same increased risk of heart attacks and stroke with high doses and long duration, and it should come back to market.
Merck, having conducted its own studies showing increased risk of death and having paid out hundreds of millions of dollars in civil suits, would not bring it back to market.
Today, it is possibly coming back as a treatment for hemophilic arthropathy, which apparently has a prevalence of about 0.001%, with plans for this since 2017.
So, I find it quite laughable that full FDA approval, let alone emergency use approval, constitutes a complete analysis of the safety of something.
And here's a long list of drugs withdrawn during post-market surveillance: en.wikipedia.org/wiki/List_of_w…
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