Actos gets warning label...and that's it
Well, almost a year later, the FDA has finally acted on Actos (pioglitazone).
Sort of.
Recently I wrote to you about the fact that, while Actos had been pulled from shelves in France, it was still alive and kicking in the United States. Despite ties to bladder cancer reported last year in a long-term study, followed by a promise to review the drug, it looked like nothing was happening.
Well, something finally has. Except it's not exactly the solution for which we'd been hoping. And, well...it's not exactly surprising.
Rather than taking any sort of real action, the FDA has taken their usual tactic of slapping on a warning label and calling it a day. We might have been hoping for a bold move like the pull in France but what we got was a box of words.
Following the warning about the drug's link to increased bladder cancer risk the FDA issued in June (and remember, the report of that risk came 10 months before that warning went out), they've released new labeling for pioglitazone.
Are you as shocked as I am? New labeling?! Why, that's...not shocking at all.
The labeling cautions that using the drug for more than a year may increase the risk of bladder cancer. It warns that pioglitazone shouldn't be used in patients with active bladder cancer, and that caution should be used with patients with a history of bladder cancer.
There's nothing there for people who don't have a history of bladder cancer--but there is the helpful hint to talk to your doctor if you experience any potential symptoms of bladder cancer. Because then you can just get another drug to take care of that!
The ten-year study that showed the connection isn't yet over--it has just over a year to go--and I'm wondering what else the researchers may find.
But I also have to wonder--will it even matter what they find? Will it just mean a few more words added to the label--or will we actually see real action taken?
Related articles of interest:
Diabetes drug pulled in France, not in the US?
Avandia Heart Problems to Actos Bladder Troubles
Diabetes drug linked to cancer (again)
Printer-friendly versionAbout the author
Christine O'Brien writes the e-letter Health eTips for Dr. Wright's Nutrition and Healing.
You can sign up for the free eTips at www.wrightnewsletter.com.
Email this Article
Comments
Lori
This is pretty typical for the FDA. These guys are in bed with pharma and pillow talk goes a long way...
Alain Cordier
...And the patients become guinea-pigs in the "real life"!
Post new comment