Will Actos Safety Profile Overshadow Perceived Benefits?

by GuestPoster on February 17, 2012

While the insulin-sensitizing effect of Actos (pioglitazone) is undisputed, its safety profile is crumbling down.

The aftermath of the 2007 findings about Avandia’s (rosiglitazone) 43 percent increased risk for heart attacks and 64 percent increased risk for dying due to cardiovascular problems, led studies to another discovery: the believed safer alternative Actos carries the same cardiovascular risk as its fallen rival Avandia.

In September 2010, the FDA informed healthcare practitioners and the public about an ongoing review of data from a 10-year epidemiological study that is still in progress up to this date. The agency believed that bladder cancer was a potential safety risk for Actos that merited comprehensive study. Based on the data available, FDA concluded that there was no statistically significant association between Actos and bladder cancer.

Nine months later, the French Health Products Safety Agency (AFSSAPS) issued an Actos recall. The drug’s withdrawal from the market came following the publication of findings of a three-year French epidemiological study with 1.5 million people. The study found that participants who took Actos the longest have significantly increased their risk for bladder cancer.

A day later, Germany limited prescription of Actos to existing users.

In June 2011, the FDA, yet again, issued a safety communication informing the public that subsequent data from the same on-going 10-year study conducted by Kaiser Permanente in Northern California established a 40 percent increased risk for the use of Actos longer than 12 months.

The findings prompted FDA to require Takeda to reflect the new development in Actos labels.

From congestive heart failure, black box warning for Actos now includes bladder cancer.

Actos, however, seemed to whether safety challenges. After surviving the rosiglitazone-instigated scrutiny, Actos is still standing tall in the face of mounting bladder cancer lawsuits caused by the FDA announcement.

In 2011, Actos sales were pegged at $3.4 billion, keeping the drug the title it held since Avandia’s fall: the best-selling diabetes drug.

Actos is still available in the U.S. market without restriction. The FDA believed that a further evaluation of subsequent data from the still ongoing 10-year epidemiological study is necessary as well as review of results from the French study.

Roughly 200 Actos-related bladder cancer lawsuits are currently under the charge of U.S. District Judge Rebecca Doherty of the Western District of Louisiana. All Actos claims were consolidated in the said federal court. Thousands of Actos-related bladder cancer lawsuits in California and Illinois have yet to be moved to Doherty’s district.

Actos maker Takeda is expected to battle more than 10 thousand lawsuits due to Actos users developing bladder cancer while or after using the diabetes drug.

Actos and Avandia belong to the class of diabetes medication called thiazolidinediones (TZDs). They act by lowering the insulin resistance in a type 2 diabetic.

Aside from heart ailments and bladder cancer, Actos can also cause weight gain, water retention, bone fracture, and  rhabdomyolisis.

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