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?
Ms. O’Brien has written for Nutrition & Healing, Healthier Talk and a variety of other natural and alternative health outlets. She believes in the power of natural medicine and her goal is to open people’s eyes to the benefits of alternative and integrative medicine.
Christine is passionate about helping people help themselves without having to turn to harsh drugs or invasive surgeries.
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This is pretty typical for the FDA. These guys are in bed with pharma and pillow talk goes a long way…
…And the patients become guinea-pigs in the “real life”!