The well-respected Consumer Reports has weighed in on whether type 2 diabetes patients should take the generic versions of Actos (pioglitazone), which were approved last week by the U.S. Food and Drug Administration.
"… We say skip Actos as both a generic and brand-name medication, unless other options have not worked," the products-review publication states. "Other medications to treat diabetes, such as metformin, are a better first choice."
Actos has been linked to many serious complications including bladder cancer, congestive heart failure, lactic acidosis, macular edema and bone fractures in women. A recent Canadian study further documented the increased risk of bladder cancer among pioglitazone users, putting it at 62 percent higher than the general population.
Bladder Cancer Risk
Researchers believe bladder cancer is associated with diabetes, and that Actos increases the risk. Type 2 diabetes occurs when a patient does not produce enough insulin or does not use insulin efficiently. If left untreated, insulin levels in the body can soar. Insulin is a hormone that stabilizes blood sugar, or glucose. Insulin also is a growth hormone, and cancer cells have insulin receptors. This allows cancer cells to use the additional insulin to grow.
Actos, which is part of the thiazolidinedione class of drugs, allows adults to control their blood sugar when diet and exercise alone do not work. The drug make the body's cells more sensitive to insulin.
The concern over Actos' link to bladder cancer has been so widespread that on June 15, 2011, the U.S. Food and Drug Administration (FDA) issued an alert saying that Actos may lead to an increased risk of bladder cancer if it's taken for longer than a year.
Generic Actos Available
Takeda Pharmaceuticals earned almost $3 billion in the past year on Actos sales in the United States alone, so it's no wonder the competition for the right to produce the generic versions was fierce. In 2010, Takeda granted shared rights to Watson Pharmaceuticals, Mylan Inc. and Ranbaxy Laboratory when its patent expired this month. The three manufacturers would have exclusive rights to market generic versions of Actos for six months. However, the FDA did not approve Watson's version, and the manufacturer sued the agency last week.
Still, Consumer Reports states that the other generics are unlikely to be less expensive than the brand-name Actos because the number of manufacturers still is limited. The publication says an Actos prescription has a retail price of $377.
Because of the serious side effects and the cost, Consumer Reports does not recommend patients take the generic versions of Actos. "Our Consumer Reports Best Buy Drug recommendation is the drug metformin, either alone or with glipizide or glimepiride, for most people with type 2 diabetes, combined with a healthy diet, regular exercise, and losing excess weight. Those three generic medications can be usually found on the discount $4 generic drug lists at the pharmacy of most chain stores such as Kroger, Target and Walmart, and may be purchased for as little as $10 for a three-month supply."