Generic Actos Has Similar Risk Of Bladder Cancer. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is warning consumers that generic versions of Actos, like the brand name, carry an increased risk of bladder cancer and other complications.
The U.S. Food and Drug Administration (FDA) approved 15 mg, 30 mg and 45 mg doses of generic Actos last week. Generic drugs are therapeutically equivalent to the brand name, but the cost is significantly lower to due to the expired patent.
However, patients should be aware that the side effects associated with Actos will also apply to the generics; generic Actos will carry a warning about the increased risk of bladder cancer, heart failure and other complications.
Takeda Pharmaceutical and Eli Lilly & Co. gained clearance for Actos in 1999 to treat patients with Type 2 diabetes. Known generically as pioglitazone, Actos is part of a class of drugs called thiazolidinediones (TZD) and work by increasing the body’s sensitivity to insulin. In recent years, studies have linked the medication to bladder cancer.
Last summer, the FDA warned that using Actos for one year may significantly raise the risk of bladder cancer. Since then, research has continually confirmed this notion. The most recent study, published in the Journal of the National Cancer Institute, found that Actos users are two to three times more likely to develop bladder cancer compared to those taking sulfonylurea.
A STUDY IN THE BRITISH MEDICAL JOURNAL (BMJ) SUGGESTED THAT PATIENTS WHO TOOK ACTOS
The month prior, the Canadian Medical Association Journal (CMAJ) published a study showing that Actos was associated with a 22 percent increased risk. In May, a study in the British Medical Journal (BMJ) suggested that patients who took Actos for two years had double the risk of bladder cancer.
Actos is also linked to congestive heart failure, a side effect that was originally only associated with its sister drug Avandia.
Unlike with brand name medications, patients taking generic drugs cannot pursue litigation against the manufacturer for failing to warn about side effects. This is due to a Supreme Court ruling that took place last year; in a case known as Pliva v. Mensing (No. 09–993.), the Court decided that generic manufacturers cannot be held liable because they are required to have the same label as the brand name and have no power to change this information.