Actos faces generic competition; Actos victims face cancer

Come to think of it, maybe it could have been a better Valentine’s Day for the leaders of Takeda Pharmaceutical Company, the maker of the type-2 diabetes drug Actos (pioglitazone). The day before, Breckenridge Pharmaceutical brass announced an inherently competitive “immediate launch of pioglitazone hydrochloride tablets,” consistent with the incipient sunset on Takeda’s Actos patent.

Previously, the U.S. Food and Drug Administration may have put a damper on Takeda’s Labor Day weekend with its August 2012 announcement that it had “approved the first generic version of Actos (pioglitazone hydrochloride) tablets,” which Mylan Pharmaceuticals would market.

Nevertheless, while Takeda has pressed on against generic competition, many patients who claim that their bladder cancer has been linked to taking Actos have fought disease and related losses, among them insurance-depleting medical expenses that can tap family budgets.

Hence, the corporation has the free-market flexibility to develop more products. But the bladder cancer patient cannot develop another body. And that is food for thought as Actos lawsuits either are settled or otherwise make their way through the judicial process. Personal injury attorneys, such as the members of Reich & Binstock’s pharmaceutical injury litigation team, have fought hard to ensure that justice is served for the victims of a serious Actos side effect.

“[Takeda] and Eli Lilly & Co. have been named as defendants in lawsuits pending in U.S. federal and state courts in which plaintiffs allege they have developed bladder cancer as a result of taking pioglitazone-containing products,” according to Takeda’s 2012 Annual Report. “A proposed class action has also been filed in the Ontario Superior Court in Canada. The Company is vigorously defending the aforementioned lawsuits.”

The FDA approved Actos in 1999. The increased risk of bladder cancer, which plaintiffs assert the manufacturer should have known and had a duty to warn about, was made public by the FDA in 2011.

“The U.S. Food and Drug Administration,” reads one of the FDA’s August 2011 drug safety alerts, “is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.”

The administration in June 2011 issued a safety statement that read, in part, “FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.”

At no cost, one of the Actos attorneys at Reich & Binstock [www.reichandbinstock.com] can examine the circumstances of a current or former Actos patient diagnosed with bladder cancer and can explain whether there is an entitlement to compensation. One may call the law firm toll-free at 1-866-LAW-2400.

“Along with diet and exercise,” explained the FDA in an August 2012 statement, “pioglitazone is used to improve blood glucose control in adults with type-2 diabetes.”