Yes, it’s probably time for warning …

It’s always gratifying to know that our pharmaceutical companies are looking out for our welfare.

Why, just last month, Pfizer Inc. was reportedly considering putting a warning on its pain reliever Bextra because of some occasional side effects similar to spontaneous combustion and death.

According to a recent Dow Jones Newswire report, Pfizer may be adding a so-called “black box” warning to the prescription drug because it sometimes causes a “serious skin condition.”

And we’re not talking the occasional rash or the heartbreak of psoriasis here, amigos. No, this skin condition, Dow Jones reports, causes one’s immune system to turn on itself to fight off the drug, “in effect burning the patient from the inside out.”


And this is a pain reliever…

The condition is called Stevens Johnson Syndrome and sufferers develop severe blisters on their skin and mucous membranes.

Jean Farrell-McCawley, founder of the Stevens Johnson Syndrome Foundation, told the Dow Jones Newswire that the syndrome sometimes causes victims’ skin to start coming off in sheets and that patients have to be hospitalized in a burn unit. The condition, she reported, has about a 30 percent mortality rate.

Burn units? Skin sloughing off? Death?

Makes contaminated flu vaccine and the recently banned Vioxx seem rather mundane, doesn’t it?

What, exactly, do you write on a warning label for this stuff?

If you want to avoid scaring off the entire population of the North American continent – and portions of Brazil and Argentina – you might simply want to indicate “WARNING: May cause symptoms similar to those of Stevens Johnson Syndrome in rare cases.”

Stevens Johnson Syndrome, after all, sounds somewhat benign on the surface, and who actually reads those wordy warning labels, anyway?

On the other hand, if you describe the side effects on your warning label you’re probably not going to attract a whole lot of new customers. They will, most likely, be running, wild-eyed, out of the pharmacy, waving their arms and wailing “Aieeeeeee!” before throwing themselves off the nearest pier.

Don’t get me wrong. I’m sure that a responsible pharmaceutical company like Pfizer thoroughly tested this pain reliever and I’m sure the Food and Drug Administration reviewed research results before approving it. And, after all, severe reactions only affect a small number of patients.

That’s not so bad – unless you’re one of that very small number of patients who unexpectedly find themselves self-immolating while watching the Super Bowl or sorting socks.

Then it’s, like, personal.

As well-intentioned as Pfizer would seem to be in considering a no-nonsense warning about Bextra, I think I’ll just limit myself to more traditional pain relievers until they get all the bugs worked out of this particular remedy.

A nickel bag of heroin, perhaps…

Originally published December 5, 2004