Warning About Incivek Promotion Issued by FDA
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Vertex warned over misleading hep C drug promotion
Boston Business Journal by Julie M. Donnelly, Reporter
Date: Wednesday, May 30, 2012
The U.S. Food and Drug Administration has issued a letter to Vertex Pharmaceuticals (Nasdaq: VRTX) saying the company published a misleading “branded story” promoting its drug for hepatitis C, Incivek. The FDA is demanding that the Cambridge, Mass.-based company, which won FDA approval for the drug in May of 2011, stop disseminating the materials in question.
The letter reads in part, “The branded story is misleading because it overstates the efficacy, omits material facts and minimizes important risk information about the drug product.”
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4 Comments
This drug is very powerful, think twice before you decide to use it.
Did you use it. What happened for you to feel that way?
Carolyn
I completed the Incivek the 1st of the year. I will never use it again! Hands, fingers, toes, feet, they all cracked and were raw. All my nails are still wavy and broken. Mouth had white puss places all around. Had to sit down especially in mornings to urinate due to rectum dropping out every time I tried to relax. Constant nausea, especially in mornings. The mental intensity, like interferon after 8 or 9 mos, from the start. Just horrible.
The FDA is continuing to warn people about Incivek. This article shows that http://www.rxwiki.com/news-release/incivek-has-small-risk-fatal-and-nonfatal-serious-skin-reactions, it is fatal in a small number of cases. But how small is small? Either way, it sounds scary!