In my secret identity, I’m the mild-mannered (okay, angry and abrasive) editor of a pharmaceutical business magazine. The big news in the biz this week was that the FDA “recommended” that Pfizer stop selling Bextra, a Cox-2 inhibiting anti-inflammatory in the same class of drugs as Vioxx and Celebrex. The move sucks for Pfizer, which bought Pharmacia for $60 billion a few years ago with the plan to use Celebrex and Bextra to build a Cox-2 powerhouse. Now it’s stuck with a bloated infrastructure, tons of redundant employees, and a business model that’s still predicated on the crapshoot of Pharma R&D.
But why is the FDA calling for Bextra’s withdrawal? Well, it’s not for the cardiac events that led to the Vioxx disaster. The FDA just wants more data on that from Pfizer. Nope, the FDA withdrawal notice cites, “Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra.”
That’s right: “life-threatening skin reactions”.
Well, I couldn’t leave that alone, so I had to find out exactly what sorta skin reactions can kill a dude. And then I found Stevens-Johnson syndrome.
Sure, at the sound of it, Stevens-Johnson syndrome oughtta just cause you to break out in slacks or drive a Volvo, but it turns out the be one monstrously messed-up medical condition. When the skin’s reaction is “sloughing off,” I understand where the “life-threatening” part comes in.
Still, that wasn’t the weirdest thing that I came across in my little research. No, it was the FDA’s drug info page for Bextra that wins that award. Because the FDA wants us to know the following:
Stop taking Bextra and call your doctor right away if you get:
Ã¢â‚¬Â¢ a burning stomach pain
Ã¢â‚¬Â¢ black bowel movements that look like tar
Ã¢â‚¬Â¢ vomit that looks like blood or coffee grounds
Now keep in mind, that’s before the serious issues with the drug arose.
And you guys wonder why I don’t quit this day job.