What Does Future Hold for Actos?

Washington, DCA decision this week by the US Food and Drug Administration (FDA) to implement long-expected restrictions to diabetes drug Avandia will further impact the fortunes of Actos—a rival Type 2 diabetes drug that has benefitted from Avandia's fall from grace, but remains encumbered by its own basketful of Actos side effects.

To that end, pioglitazone (Actos) has been linked to Actos bladder cancer and Actos heart failure. No one in the medical community has ever suggested that Actos is without risk. However, when compared to Avandia, Actos has long been considered the safer alternative.

The question remains if that position will be maintained or change as more Type 2 diabetes patients are expected to migrate to the Actos camp once the FDA restrictions on Avandia go into effect in November.

An FDA advisory committee voted overwhelmingly last year to either severely limit Avandia use or pull it from the market altogether. In the end, the FDA decided to take the former route. According to the May 19 issue of USA Today, restrictions go into effect November 18. In sum, only certified doctors will be allowed to prescribe Avandia as a drug of last resort to patients who are fully informed of the risks. Rosiglitazone (Avandia) will only be available from specific pharmacies.

The latter approach, which has been deemed "reasonable" by David Holmes, a Mayo Clinic physician and president of the American College of Cardiology, will most assuredly drive further traffic to Actos. The question remains, what might be in store for a groundswell of Actos diabetes patients once the Avandia restrictions are in place?

Type 2 diabetes, according to USA Today, affects some 23 million people in the US. With the majority now moving away from Avandia and potentially favoring Actos, what will the impact be on adverse reaction levels with regard to the potential for Actos congestive heart failure (Actos CHF) or Actos and bladder cancer?

When Actos was first deemed as the safer alternative when the Avandia bomb burst in 2007, rosiglitazone (Avandia) was at the time the runaway leader in the treatment for Type 2 diabetes. That tide has turned in massive fashion over the past four years, and will likely continue to evolve through November and beyond, when the long-awaited Avandia restrictions take effect.

How then, will Actos side effects shake out? What will be the numbers for adverse reactions to pioglitazone, as the numbers of patients continue to climb? Time will tell…