Controversial Diabetes Drug Actos Still on the Market

Though research has shown an association between the type 2 diabetes drug Actos and serious side effects including bladder cancer, heart failure, liver failure, and bone fractures, the Food and Drug Administration (FDA) has stopped short of recalling Actos.

Actos (pioglitazone) has been pulled from the market in Germany, France, and India. In the U.S., the FDA has issued safety communications about potentially serious side effects and the drug carries a black box warning for heart failure. The FDA said it is closely following ongoing research studies in the United States and abroad. The law firm Parker Waichman LLP notes ongoing litigation involving Actos side effects, in particular bladder cancer.

Actos Background

Actos, which has been on the market since 1999, is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes. Actos works by lowering insulin resistance, a condition in which cells do not fully respond to insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels become abnormally high.

Pioglitazone is available as a single-ingredient product (Actos) and in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).

Early Evidence of Actos Side Effects

Actos, made by Takeda Pharmaceuticals, became the world’s best-selling diabetes drug in 2007 after rival drug Avandia (rosiglitazone), was linked to a higher risk of heart attack. Before the FDA approved Actos in 1999, premarket studies showed bladder tumors had developed in animals. Takeda launched a 10-year study to investigate the long-term bladder cancer risks. The first five years of the study showed an increased risk.

Soon after Actos came to market, the FDA started receiving adverse reaction reports claiming Actos had caused congestive heart failure and other cardiovascular problems. The FDA did not require a black box warning until nearly eight years later, after the Journal of the American Medical Association (JAMA) published a study that linked Actos to heart failure.

In 2011, French regulators ordered doctors to stop prescribing Actos because of the bladder cancer risk. The French Medicines Agency conducted a study, which found that users of the diabetes drug have a 22 percent higher bladder cancer incidence than those taking other diabetes drugs.

Takeda Study Prompts Calls for Actos Recall

In its drug-safety announcement, the FDA said it is continuing to evaluate the data from the Takeda Pharmaceuticals study. The FDA will also review the results of a French epidemiological study that monitored about 1.5 million diabetes patients. That four-year study showed a “statistically significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents,” according to

To issue a recall, the FDA must conclude that there is a “reasonable probability” that the drug in question will cause “serious adverse health consequences or death.” French medical regulators recalled Actos in June 2011.

The FDA updated the Actos drug label to include a warning that the use of pioglitazone for more than one year could be associated with an increased risk of bladder cancer, though the agency did not require the risk to be presented in a separate Medication Guide. The FDA recommends that patients with active bladder cancer should not use pioglitazone. The agency also said patients with a history of bladder cancer should use pioglitazone with caution.

Controversial Diabetes Drug Actos Still on the Market

Controversial Diabetes Drug Actos Still on the Market

In addition to the bladder cancer risk, experts cite serious side effects including heart failure, heart attacks, and serious liver problems as reasons why Actos should be recalled.

This year there has seen mounting legal action against Takeda and Eli Lilly & Co., which jointly marketed Actos originally. Bloomberg News reports that the two drug makers could face as many as 10,000 bladder cancer lawsuits. The U.S. judicial panel on multidistrict litigation decided that all Actos lawsuits pending in federal court should be consolidated and heard in U.S. District Court for the Western District of Louisiana.

In April 2016, Takeda agreed to a settlement program that would pay out  $2.37 billion if 95 percent of eligible plaintiffs agree to participate and $2.4 billion if at least 97 percent choose to participate, Bloomberg News reports. Each eligible plaintiff could receive more than $296,000.

Help for Those Who Suffer Serious Actos Side Effects

If you or someone you know taking Actos has suffered serious side effects, you should contact the experienced Actos attorneys at Parker Waichman LLP for a free, no-obligation case evaluation. Contact Parker Waichman by submitting the online form or calling 1-800-YOURLAWYER (1-800-968-7529).



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