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On January 25, 2013, the FDA approved three new related products made by Actos manufacturer Takeda, for the treatment of type 2 diabetes. Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride), and Oseni (alogliptin and pioglitazone) will now be available by prescription to patients struggling to control blood sugar levels.

The new drugs come on the market just as Takeda reported its operating profit down 53 percent and net profit down 14 percent in the nine months that ended December 31, 2012. Over the six-month period ending September 30, 2012, sales of Takeda’s previous type 2 diabetes drug, Actos (pioglitazone), dropped 46.2 percent from the previous year.

The drop in sales is attributed both to generic competition and to the increasing number of Actos lawsuits filed around the country. In June 2011, the FDA warned healthcare professionals and patients that taking Actos for more than a year could increase risk of bladder cancer.

Actos Linked with Bladder Cancer

The FDA approved Actos for the treatment of type 2 diabetes in 1999, but as early as 2005, studies indicated its potential link to bladder cancer. That year, the results of the PROActive three-year study were published. Researchers looked at cardiovascular outcomes in patients using the drug, but discovered during the course of the study that there was a significantly higher percentage of bladder cancer cases in patients taking Actos than those taking other similar drugs. These results were not published in the final paper, however, nor did Takeda alert physicians to the findings.

On September 17, 2010, the FDA issued a safety announcement stating it was reviewing the data from an ongoing, ten-year epidemiological study evaluating the association between Actos and bladder cancer. That review later concluded in June 2011 that patients taking Actos for more than 12 months were at a 40 percent increased risk of bladder cancer.

On August 17, 2012, the FDA approved the first generic version of Actos made by Mylan Pharmaceuticals.

Actos Lawsuits Consolidated

Following the FDA warning, many patients came forward to file an Actos lawsuit, claiming Takeda failed to adequately warn about the serious health risks associated with taking the drug for more than a year. In July 2011, France implemented an Actos recall because a study there reported similar results, but the drug remains available in the U.S.

As the number of lawsuits filed began to increase, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal cases consolidated into one court in the Western District of Louisiana. Over 1,200 Actos lawsuits are now pending there. The first bellwether trials are scheduled to begin in November 2014.

The first state case to go to trial began on February 18, 2013, in Los Angeles, where plaintiff Jack Cooper, who took Actos for more than three years, claims the company didn’t properly warn consumers that the drug could cause bladder cancer.

New Drugs May Boost Takeda’s Bottom Line

Takeda is likely looking to its new drugs to boost the bottom line as it faces rising litigation related to Actos. According to the FDA, “alogliptin” is a new active ingredient that helps stimulate the release of insulin after a meal, leading to better blood sugar control. Though this is a new ingredient, the other two drugs—metformin hydrochloride and pioglitazone—are already used to treat type 2 diabetes in the U.S.

The FDA has required postmarketing studies for Nesina, however, to further examine any links to cardiovascular problems, liver abnormalities, pancreatitis, and severe hypersensitivity reactions. They’re also requiring postmarketing studies for Kazano, to look at its effect on the liver and pancreas, as well. Patients may want to talk to their doctors about delaying any new prescriptions until the results from these studies are in.

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