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Actos Recall

Because of the link between Actos and side effects like congestive heart failure and bladder cancer, the FDA has added black box warnings and safety updates to the labeling. France and Germany have taken steps to recall the drug, preventing more people from being harmed by these adverse events.

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Popular diabetes drug Actos has been linked to bladder cancer and heart failure, but the FDA hasn’t issued a recall. However, in light of the drug’s serious side effects, the FDA is closely monitoring ongoing postmarket studies.

Actos Bladder Cancer Warning

In 2007, the FDA issued a black box warning highlighting the connection between ACTOS use and congestive heart failure. The warning urges that patients be closely monitored for excessive, rapid weight gain, shortness of breath, and edema, all signs of congestive heart failure.

On June 15, 2011, the FDA warned consumers that use of the drug for a period of more than a year could increase the risk of bladder cancer. The warning was based on a five-year interim analysis of an ongoing, ten-year epidemiological study of 193,099 patients with diabetes, conducted by the drug’s manufacturer, Takeda, in conjunction with insurer Kaiser Permanente.

The agency advised doctors not to administer Actos to patients with active bladder cancer, and to be cautious when prescribing it to patients with a history of bladder cancer. The FDA noted that, while the interim analysis did not conclusively support a statistically significant link between Actos use and bladder cancer, there was some correlation in patients with high/prolonged dosage. The agency added language about the link to bladder cancer to the WARNINGS AND PRECAUTIONS section of the ACTOS label.

Actos Recall in France and Germany

In 2011, both France and Germany issued a recall for Actos in response to a study authored by France’s national health insurance body that suggested an increased risk of bladder cancer in subjects taking the drug. The study followed approximately 1.5 million patients between 2006 and 2009. Like the Takeda study, it also demonstrated that risk factor rose as Actos dosage increased. The FDA’s 2011 warning, issued less than a week after the recall, acknowledged the results of this study.

France recalled the drug on June 9, 2011, with Germany quickly following suit. Officials in both countries advised patients currently on Actos not to suddenly discontinue use, as withdrawal could be dangerous.

Takeda Studies

A 2012 analysis of 10 previous studies, which in total looked at more than 2.6 million patients, concluded that Actos use correlated with an approximately 22% increase in the risk of bladder cancer. (Type 2 diabetes by itself increases risk of bladder cancer by approximately 40%.) The FDA acknowledges that the clinical evidence in support of an Actos–bladder cancer link in both human and animal subjects merits further analysis. The agency is monitoring the results of the ongoing Takeda study, and will continuously reevaluate its stance on Actos as more data becomes available.

Rezulin (troglitazone) Recalled

On March 21, 2001 Parke-Davis/Warner Lambert agreed to the FDA’s request to withdraw Rezulin, a medication similar to Actos, from the market. A review of safety data on Rezulin and two similar drugs, Avandia (rosiglitazone) and Actos (pioglitazone), showed that Rezulin is more toxic to the liver than the other two drugs that offer the same benefits as Rezulin without the same risk. 1

  1. FDA News Release on Rezulin Safety http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173081.htm