Actos controversy continues

The type 2 diabetes drug pioglitazone, or Actos as it is known by its brand name, has been at the center of a great deal of controversy lately. Studies have shown that it may carry a substantial risk of side effects, yet experts say it remains one of the most effective treatments for poorly managed blood sugar.

The European Medicines Agency recently affirmed that the medication should not be taken off the market, despite fears that it may increase the risk of bladder cancer, according to the Pharma Letter. The agency stated that the studies indicating increases in bladder cancer risk only showed a modest correlation, and pioglitazone is an invaluable medicine for managing blood sugar.

Many of the people who are prescribed pioglitazone are only given the drug after other medications have proven ineffective. This may mean that concerns about a slight increase in bladder cancer risk are the least of these patients' worries. They should be primarily concerned about poorly managed blood sugar.

For these reasons, the agency only recommended putting warning labels on the medication and letting medical professionals determine whether the risk is worth it. The U.S. Food and Drug Administration issued a similar warning about the medication over the summer, but also declined to pull Actos.

Still, some groups are concerned about the increased risks associated with Actos. The law firm Williams Kherkher recently initiated a suit against Takeda Pharmaceuticals, the company that makes the medication. Lawyers said the organization may be responsible for the pain, suffering and medical expenses of individuals who have developed bladder cancer while taking Actos.

Much of the concern over the potential side effects associated with Actos stems from a review of the safety and efficacy of the drug conducted by Takeda five years after it was approved by the FDA. The results initially showed little overall correlation between pioglitazone use and bladder cancer. However, when investigators dug deeper into the numbers, they found that those who had been taking the drug for extended periods of time appeared to have slightly higher rates of cancer.

The FDA now warns physicians to be aware of this risk and weigh them against potential benefits.