Bladder Cancer Linked to Type 2 Diabetes Drug

From nearly the moment it was invented, the type 2 diabetes drug Actos has been linked to bladder cancer. During the drug’s clinical trials, bladder tumors showed up in male lab rats. Once the drug was released to the public, the disease started showing up in Actos patients. Yet, despite these Actos complications, the drugs’ sales shot through the roof.

With the help of tiny font, glitzy advertising and the downfall of its main competition, Actos rose to stardom, and the bladder cancer risk went largely unnoticed for years. By the time researchers had definitive proof, Actos had a hold on the market and the drug was established as a household name.

Actos Moves In

It began in 1999 when the U.S. Food and Drug Administration (FDA) approved Actos for sale. The active ingredient, pioglitazone, works by making the cells more receptive to insulin, a key component to type 2 diabetes control. While Takeda was trying to establish Actos as the go-to drug, another drug in the same family, GlaxoSmithKline’s type 2 diabetes drug, Avandia, was having its own problems.

At the time, Avandia was on the top of the type 2 diabetes drug food chain — that was, until it was linked to heart problems. Seeing their chance, Takeda executives pushed Actos as a safer alternative. The public bought into it.

Soon Actos owned the diabetes market. Doctors, convinced that Actos was a safer medication with few or no side effects, wrote millions of prescriptions – more than 100 million prescriptions globally by 2011.  Patients trusted it.

Actos-Bladder Cancer Link Revealed

While all this maneuvering was going on, Actos had a secret in plain sight. Written in tiny font on the drug’s label, Takeda revealed that the medication was shown to cause bladder tumors in male rats.  Even though the FDA knew of the risks, most of the public did not. The FDA ordered Takeda to launch a 10-year investigational study into the link at the same time the drug was made publically available. In 2007, Takeda said the initial results of the study showed that those taking the drug for longer than a year had 40 percent increased risk for bladder cancer.  About the same time, drug regulators in Germany and France revealed similar findings from their own Actos study. Some European countries banned or restricted the drug’s sales. The FDA’s response was to only added more wording to the drug’s label, underscoring the bladder cancer risk.

Actos Collapse?

Today, Actos has fallen out of favor with physicians and patients. Doctors don’t want to prescribe it, and patients don’t trust it. While the Takeda-run study won’t be completed until 2013, the latest independent study shows that Actos increases the bladder cancer risk up to 80 percent. At the same time, a whistleblower has accused Takeda of orchestrating the downfall of Avandia to promote Actos and skewing the FDA data to make the drug seem safer.
What’s left are the patients who are left diseased and worried after taking Actos? Many have started filing Actos lawsuits, against Takeda.

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