Generic Actos and Bladder Cancer   (August 21, 2012)

This past week, the FDA approved the first generic version of pioglitazone (Actos) for the treatment of T2DM.

As I had anticipated, the FDA News Release mentioned the concern that the current version of pioglitazone (Actos brand) has been associated with some nasty side effects, including an increased risk of heart problems, and risk of bladder cancer: “The drug has a Boxed Warning to emphasize that pioglitazone may cause or worsen heart failure, particularly in certain patient populations. Careful monitoring of patients when starting the drug or increasing the dose is recommended. The product label also notes that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.”

But you’d never know about the bladder cancer risk from the generic manufacturer’s press release. The same day as the FDA press release, Mylan Inc announced their immediate launch of Generic Actoplus Met® Tablets and Generic Actos® Tablets. But if you were to believe the press release, the side effect profile isn’t the same: In their discussion of side effects of pioglitazone, they indicate pio “can cause or exacerbate congestive heart failure in some patients and therefore patients should be monitored for signs and symptoms of heart failure. Patients with symptomatic heart failure should not take this medication.”

Nothing about bladder cancer. That’s despite the FDA issuing myriad reports about Actos/pioglitazone, recently recommending that “healthcare professionals should not use pioglitazone in patients with active bladder cancer, [and] use pioglitazone with caution in patients with a prior history of bladder cancer.” Patients are advised to “Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.”

The precise wording of the generic drugs’ label isn’t clear, as only the brand-name Actos label is currently on-line at the FDA’s website.

But the August 17th approval letter sent from the FDA to Mylan is online, and states that the content of the labeling must be “identical in content to the approved labeling (including the package insert, and any patient package insert and/or Medication Guide that may be required).” So the label for Mylan’s generic pioglitazone will have to mention the bladder cancer risk.

I guess that it’s just their press flacks who didn’t think it’s important enough to mention.