What's Going On With Actos?

Many of you may have heard the recent fuss about Actos.  The source of much of it is the FDA's recent decision on August 4, 2011, to update the Actos label.  The new information added to the Warnings section of the label (Which, I have found, is read more by lawyers than by anyone else.  Yes, I'm talking about the label that comes with the drug. It turns out that Doctor's depend on the drug company sales representatives to let them know about the dangers of a drug.  But I digress)  recommends that healthcare professionals should not use Actos (pioglitazone) in patients with active bladder cancer and to use caution in using it in patients with a prior history of bladder cancer.  All of this came about because of the results of some scientific studies.  One was a study that looked at some data from the French National Health Insurance Plan, which showed a significant increase in the risk of bladder cancer when comparing Actos to other anti-diabetic drugs.  The other, was when the interim results were reviewed of a 10 year long-term study of patients with diabetes who are members of the Kaiser Permanente Northern California Health Plan.  This long-term study (that's the problem with long-term studies, they take a long time) indicated that an "increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone."  Of course, the FDA is behind the rest of the world as usual when it comes to protecting patients from risky drugs:  France has already suspended the use of Actos, and Germany has recommended not to start Actos in new patients.  The FDA, in the meantime, will "continue to evaluate data from the ongoing ten-year epidemiological study."  Don't hold your breathe.  And, I would recommend, be very inquisitive of any doctor who wants to put you on Actos.