Currently viewing the category: "black box warning"

Breaking Up is Hard to Do

By On · Add Comment · In American Psychiatric Association (APA), antidepressants, black box warning, drug companies, medical seminars
Well, hallelujah. There is hope. Apparently some doctors see a problem in accepting gifts from drug companies, too. The American Psychiatric Association (APA) will be considering a proposal from some of its members to halt the practice of medical seminars being funded by pharmaceutical companies. No guarantee that the board will also see it as a problem, but this is a good start.

Drug companies have been courting doctors for years, with trinkets, luxury trips, and cash. It’s not uncommon for doctors to earn big bucks speaking in favor of one drug or another (of course we mean name brands). And antidepressants are high on that list. Considering the questionable effectiveness, and the even more shaky science behind these highly over-prescribed drugs, and you can only imagine why pharmaceutical courting exists.

Here is the problem: When doctors are paid by a pharmaceutical company–like Wyeth, makers of Effexor, let’s say–then do you think those doctors will recommend any other option? When full-on seminars are sponsored by drug companies, do you think that most attendees will be prescribing Effexor like crazy on Monday? Do you think drug companies will place their product in anything but the most positive light? That’s exactly how drugs like Prozac, Luvox, Paxil, Celexa, Lexapro, and Zoloft received black box warnings after they had been on the market for several years, despite the fact that research showed a hightened risk for violence and suicidal tendencies in children. Do you think the manufacturers of these drugs disclosed these very important findings to their seminar attendees?

But once again, thank goodness some doctors and medical groups like the APA see the inherent problem. As former editor of the New England Journal of Medicine, Dr. Marcia Angell, says,

“It is self-evidently absurd to look to a company for information about a product it makes. Why can’t doctors, who are among the most privileged members of society, pay for their own continuing medical education? Why have they abdicated that responsibility to the companies who make drugs?”

And for those doctors who think they are above being persuaded, Dr. Angell adds,

“There are still those who feel strongly that they can hear things but it doesn’t influence their practice. But the evidence points the other way.”

Precisely.

Warning: Antibiotic May Cause Tendon Rupture

By On · Add Comment · In antibiotic, black box warning, Cipro, fluoroquinolones, Food and Drug Administration (FDA), tendons

If you’re currently taking the antibiotic Cipro, here’s something you might want to know: it can cause tendons to rupture. So says a consumer group called Public Citizen that wants the Food and Drug Administration (FDA) to add a “black box” warning to the antibiotic.

Cipro is in a class of antibiotics called fluoroquinolones, and as of 1997, the FDA has received 336 reports of tendon rupture in patients treated with these compounds. Public Citizen claims that the numbers might actually be higher since not all side effects are reported to the FDA. Cipro is often prescribed for gastrointestinal, respiratory and urinary tract infections. It also was brought to the surface of American consciousness during the anthrax scare of the early part of the decade. Cipro can also cause liver damage, kidney damage and rhabdomyolysis (muscle wasting and pain), so it’s not something to be taken lightly.

Well…tendon ruptures suck–they’re horrible; some of the hardest things to recover from. I’ve referred patients with this condition orthopedists, and when the tendons are frayed like string cheese, they are very difficult to reattach. The weaker the tendon, the more likely it will be torn during a routine activity, like running for the bus, or stepping off of a chair–something simple. I guess if you’re exposed to anthrax, then you’ll need a bunch; but if there is an alternative–and you’d be wise to ask your doctor–I’d consider it.

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