Will Actos Go the Way of Avandia?

Los Angeles, CAThe makers of Actos diabetes medication are probably feeling okay right now. Despite some concerns about Actos side effects, worry about the medication is not as strong as concern about rival drug Avandia was. And, despite a possible reported link between Actos and rhabdomyolysis, there has been no significant movement against Actos and no recall.

But, at some point, the makers of Avandia must have been feeling okay, too. At one point, Avandia was the highest-selling diabetes medication, making $3 billion in sales. Nowadays, GlaxoSmithKline, maker of Avandia, faces strict usage rules for its diabetes medication and lawsuits filed by patients who say they were harmed by the medications.

Bloomberg (05/04/11) reports that GlaxoSmithKline is about to settle another 1,000 lawsuits filed against the company. In the past year, the drugmaker agreed to pay approximately $700 million to settle around 12,000 lawsuits, which alleged the company failed to adequately warn patients about the risks of heart attacks and strokes associated with the medication.

Because of the strict limitations put on Avandia use, the expectation is that Actos will replace Avandia as the number one diabetes medication. A trial, called the Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial, which was meant to examine the safety of Avandia compared with Actos was halted, so how much safer Actos is than Avandia will never be known. One study, published in 2009 in the British Medical Journal, found that patients who took Actos had a lesser risk of developing heart failure or dying than patients who took Avandia.

The FDA has recently announced some potential safety issues with Actos. One potential safety issue is a possible link between Actos (known generically as pioglitazone HCL) and rhabdomyolysis. Rhabdomyolysis is a potentially serious condition, in which the patient's muscle fibers deteriorate and can possibly lead to kidney failure. A potential safety issue means that the FDA is aware that Actos is associated with a risk of rhabdomyolysis but has not been proven to cause the condition. The FDA is reportedly evaluating the issue to determine if any regulatory action should be taken.

Meanwhile, the FDA is also evaluating a possible link between Actos and bladder cancer. Much like the link between Actos and rhabdomyolysis, there has been no causation proven.