Many adults are impacted by Type 2 diabetes (sometimes referred to as adult-onset diabetes or non insulin-dependent diabetes). Type 2 diabetes is a chronic condition that affects the way your body metabolizes sugar. Left untreated it can be life-threatening. However, the condition can be managed. Often, it can be managed through diet and exercise. Unfortunately, sometimes medications are necessary.
The Mayo Clinic website has an excellent chart that lists various medications used to treat Type 2 diabetes. These medications fall into several different categories of drugs. Each category works to manage the condition through a different process.
Actos is in the category known as glitazones, that were designed to increase the cell's sensitivity to insulin. What other medications were in this same category? One medication in this category was Rezulin which was withdrawn from the market in 2000 due to issues with liver toxicity. Another was Avandia which has been severely restricted as a result of heart issues. I have written on prior occasions about the problems with Avandia. Since my last post on Avandia, there have been new developments concerning the potential harm of that drug.
After these other two drugs were removed or severely restricted in use, the number of Actos prescriptions grew substantially. How much money did Actos generate for Takeda, the Japanese company producing the drug? A 2011 article on pharmaceutical sales revealed that Actos recorded $3.58 billion in sales over just the first 9 months of 2010.
Now, we learn that Actos may also present considerable health risks. In September 2010, the FDA issued a safety announcement about the potential risk of bladder cancer after extended consumption of Actos. At that time, the FDA said it was reviewing data to determine the association between Actos and bladder cancer. According to the FDA safety announcement
An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as those exposed to the highest cumulative dose of Actos.
In June 2011, both French and German regulators suspended the sale of Actos in their countries citing studies linking the drug to an increased risk of bladder cancer. Also, in June 2011, the FDA issued a new safety announcement about Actos. In this announcement the FDA specifically warned consumers that
use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.
Since Takeda introduced Actos, millions of prescriptions have been issued. The physicians prescribing the medication were not aware of these risks until the FDA recently issued its safety announcements. This does not appear to be true for the manufacturer Takeda. In fact, evidence suggests that Takeda knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical studies, which showed an increase in drug-induced tumors in the bladders of rats. Yet, Takeda sold Actos without any warning of this increased risk until the FDA's recent actions requiring additional warnings. And yet, bladder cancer may not be the only problem associated with Actos. The latest studies indicate that bladder cancer is only one of Actos' potentially life-threatening side effects.
It is very difficult to hear the story of a patient who now suffers cancer after taking Actos for an extended period of time. Then, on top of that, you consider the evidence that the company may have known of problems and yet sold billions of dollars of pills without a warning. I think much more information will be revealed in the coming months about the impact of this drug on patients.