Actos Recall

Although all medications carry the risk of some side effects, certain drugs, such as diabetes medication Actos, have been linked to potentially deadly complications, including cancer. Since these serious Actos complications came to light, more than 2,500 lawsuits have been filed in federal court, with additional Actos lawsuits filed in state courts.

Plaintiffs in these cases claim that Takeda Pharmaceuticals, the manufacturer of Actos, knew of the risks, yet concealed them. Numerous scientific studies have been conducted by independent researchers which substantiate the plaintiffs’ claims of an increased bladder cancer risk linked with 12 or more months of continual Actos use.

Because of these health concerns, Takeda’s popular type 2 diabetes drug has been removed from pharmacy shelves in France and Germany, leading market watchers to speculate about a potentital Actos recall in the United States.

About Actos

Actos (pioglitazone) is in a category of drugs known as thiazolidinediones (TZD). It is an oral medication prescribed for the treatment of type 2 diabetes. Along with an exercise program and diabetes diet plan, Actos is intended to help patients maintain stable blood sugar levels for long-term management of the disease.

Many plaintiffs who have filed Actos lawsuits against Takeda Pharmaceuticals claim they developed bladder cancer as a result of taking Actos. The link between cancer and the drug has been substantiated by independent studies and the U.S. Food and Drug Administration (FDA). Furthermore, Actos is known to cause and/or worsen congestive heart failure, characterized by rapid weight gain, edema, and difficulty breathing.

Some of the other serious side effects associated with Actos include the following:

• Vision problems
• Bloody urine
• Bone fractures
• Liver disease
• Allergic reaction 

Actos recall overseas

After reports of adverse Actos side effects began surfacing, government bodies overseas began investigating the drug. France was the first country to issue an Actos recall, banning the drug from use following a study by the French Medicines Agency. This study determined that the risk of bladder cancer in patients using Actos was 22 percent higher than in patients using alternative diabetes drugs. This ban was issued in June of 2011. Prior to the ban, about 230,000 patients in France had been taking Actos.

The European Medicines Agency had already begun its own review of Actos in March 2011. After the results of the French study were publicized, German drug regulators followed suit and ordered doctors to cease prescribing Actos.

In July 2013, the Indian Ministry of Health and Family Welfare issued its own Actos recall. They ordered all products containing pioglitazone removed from the market. The Madras Diabetes Research Foundation conducted a study on Actos, which found that for every 70 patients who were prescribed the diabetes drug, 13 of them were later diagnosed with bladder cancer. Those patients had not previously had bladder cancer.

The director of the research foundation suggested that even low dosages of Actos could be dangerous.

The recall of Actos in India is quite significant because until that point, pioglitazone had been considered to be the gold standard of diabetes treatment in the country, particularly since an alternative medication, rosiglitazone, had already been banned. Since the only other major treatment available in India is insulin, it is expected that the Indian government will consider reauthorizing the sale of Actos with a strong warning label.

FDA conducts ongoing safety review, issues warnings

In September 2010, the FDA began conducting its own safety review of Actos. Specifically, the agency evaluated the link between the long-term use of the drug and the formation of tumors. The 10-year epidemiological study will be accompanied by a rigorous review of the data from the French study.

Although the study is still ongoing, the FDA has already issued public safety announcements. In June 2011, the FDA determined that the use of Actos for longer than one year could be linked with a higher risk of bladder cancer. This determination prompted the revision of warning labels, which were approved in August 2011.

Failure to recall Actos in the U.S.

Despite the findings by the FDA, there has not been an Actos recall issued in the U.S., a fact that has caused alarm among patients and healthcare professionals. Takeda Pharmaceuticals has chosen not to suspend sales of the drug, despite facing thousands of lawsuits from plaintiffs who claim the company failed to issue adequate warnings.

So many Actos lawsuits have been filed that the Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) to streamline the litigation process. MDL No. 2299 is proceeding in the U.S. District Court for the Western District of Louisiana; Judge Rebecca Doherty is presiding. The parties are anticipating the first bellwether trial in the MDL to start on January 27, 2014, and the second trial to begin on April 14, 2014.

Some plaintiffs who filed lawsuits in state courts have already had their day in court.

Scientific studies substantiate need for recall 

As Actos litigation moves forward, the results of further clinical research regarding the safety of the medication continue to be published. These studies further solidify the link between Actos and life-threatening side effects.

One such study was publicized in July 2012. The study’s senior author was Jeffrey A. Johnson, who holds the Canada Research Chair in Diabetes Health Outcomes at the University of Alberta School of Public Health.

“The evidence suggests that this drug is associated with about a 22 percent increased risk of bladder cancer,” said Johnson. While the researchers were unclear exactly how Actos increases the risk, they used animal studies to form a hypothesis. The research from those studies suggests that the drug results in the formation of small crystals that cause bladder irritation, leading to an increased likelihood of cancer.

Another study, published on May 31, 2012 in the British Medical Journal, associated Actos use with a doubled risk of bladder cancer when the drug was taken for two years. The ongoing clinical research highlights the necessity of a safer alternative for diabetes patients.

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