FDA confirms type 2 diabetes drug link to bladder cancer

Every drug is a roll of the dice. And now the FDA has made it official: Actos users are rolling the dice on bladder cancer.

As I told you earlier this week, France’s drug authority recently told doctors to stop prescribing Actos based on a new study that links the type 2 diabetes drug to bladder cancer risk.

Here in the U.S., FDA officials are not quite as cautious. They’re reviewing the evidence and they’ll have a report “within the next couple of months.”

In other words…it’ll be a year.

Meanwhile, the information the FDA has right now makes it clear that by the time the report is ready, a good number of Actos users — perhaps hundreds -– may have developed bladder cancer.

According to FDA calculations, Actos use among 100,000 patients for over one year may result in 27.5 excess cases of bladder cancer.

So let’s do the math…

The agency says that about 2.3 million patients filled prescriptions last year for drugs that contain pioglitazone (that’s the active ingredient in Actos, also used in a couple of drugs that combine the ingredient with another active ingredient).

If all of those patients continue their pioglitazone use for one year, we’re looking at a potential of more than 630 new patients with bladder cancer who may not have otherwise developed the cancer.

In cases like this, I like to apply the Sliding Supplement Scale to get a reality check: If Actos were a dietary supplement, would it be banned immediately?

Source:
“Pioglitazone for 1 Year May Increase Risk of Bladder Cancer” Shelley Wood, Medscape, 6/15/11, medscape.com