Actos Recall Information


Even though the type 2 diabetes drug Actos (pioglitazone) has been linked to bladder cancer, heart failure and eye problems, U.S. drug regulators have not issued a recall.

Instead of implementing an Actos recall, the Food and Drug Administration (FDA) is continuing to closely follow ongoing studies in the United States and abroad. The FDA also has released a drug safety announcement that highlights potential Actos dangers. The drug was pulled from the market in Germany, France and then India.

Countries that recalled Actos



No Ban

The medication, which has been on the market since 1999, has been linked to an 83 percent higher risk of bladder cancer. It has also been linked to other serious side effects such as liver failure and bone fractures.

Although there has not been an Actos recall in the United States, you still have legal rights. If you developed serious health complications after taking Actos, like bladder cancer, you may have legal options for compensation to cover medical expenses as well as pain and suffering. For additional information about Actos lawsuits, please call (800) 452-0949 or fill out the form on this page.

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If you have bladder cancer after using Actos, ask about your legal options.

Actos Recall Background Information

Actos became the world’s best-selling diabetes drug in 2007 after rival drug Avandia (rosiglitazone), made by GlaxoSmithKline, was linked to a higher risk of heart attack. The active ingredient in Actos, pioglitazone, works by increasing the body’s sensitivity to insulin, a natural hormone that helps control blood sugar. Avandia and Actos come from the same family of drugs, thiazolidinediones (TZDs).

Before the FDA approved Actos in 1999, premarket studies showed bladder tumors had developed in animals. Actos manufacturer Takeda Pharmaceuticals soon launched a 10-year study to investigate the long-term bladder cancer risks. The first five years of the study showed an increased bladder cancer risk.

Although the FDA has not implemented an Actos recall, drug regulators in France and Germany have ordered doctors to stop prescribing Actos because of bladder cancer risks. The drug-regulation body in Europe, the European Medicines Agency (EMA), is performing its own safety review, saying the drug is safe in certain circumstances. The French Medicines Agency conducted its own study, which found that users of the diabetes drug have a 22 percent higher bladder cancer incidence than those taking other diabetes drugs.

FDA Study Leading Some to Call for an Actos Recall

Actos Recall FDA WarningIn issuing the drug-safety announcement, the FDA said it is continuing to evaluate the data from the Takeda Pharmaceuticals study. The agency also will review the results of an epidemiological study in France 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.”

To issue a recall, the FDA must generally 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.

While the FDA is reviewing the data, it has issued advisories for health care professionals and Actos patients. The agency also updated the Actos drug label to include safety information stating that the use of pioglitazone for more than one year could be associated with an increased risk of bladder cancer. In May 2012, however, the FDA dialed back its requirement that Actos risks be given to patients 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.

To issue a recall, the FDA must generally conclude that there is a “reasonable probability” that the drug in question will cause “serious adverse health consequences or death.”

“The benefits of blood-sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence,” the FDA stated.

In recent months, there has been mounting legal action against Takeda and Eli Lilly & Co., which jointly marketed Actos originally. Bloomberg News reports that the drugmakers could face as many as 10,000 bladder cancer lawsuits. Recently, a 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 Lafayette. U.S. District Judge Rebecca Doherty will oversee the pretrial proceedings.

Just because Actos has not been recalled does not mean you do not have legal options to seek compensation for injuries developed due to taking the diabetes drug. You still have legal rights. To learn more about Actos lawsuits and your legal rights, please call us at (800) 452-0949 or fill out the form near the top of this page.

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