Actos® and the FDA

Actos®, the brand name of the diabetes drug pioglitazone is manufactured and distributed by Takeda Pharmaceuticals. Since the drug’s introduction by Takeda in 1999, the company has been forced to revise its official usage and recommendation labels several times by the U.S. Food and Drug Administration (FDA). Changes to the label were mandated by the FDA after reports from several studies showed that pioglitazone use may be linked to an increased risk of developing congestive heart failure and/or bladder cancer. The following drugs other than Actos® contain pioglitazone and are included in the FDA actions: Actoplus Met and Duetact.

Actos® and Congestive Heart Failure

The first FDA revision to the official prescribing information for Actos® and other pioglitazone-based drugs was made in August 2007. The revision includes a new boxed warning, updated warnings, and updated precautions and contraindications all related to the increased risk of congestive heart failure. The warnings came about after several reports of heart failure in patients taking Actos®. The increased risk of heart failure is thought to be related to one or more recognized side effects of the drug: fluid retention, edema and weight gain.

Patient Information – Healthcare practitioners and physicians are warned that all patients must be informed that Actos® may cause fluid retention, which can lead to congestive heart failure. Patients are also to be advised that any symptoms of congestive heart failure should be immediately reported to a physician. These symptoms include fluid retention, edema, rapid weight gain, fatigue, and difficulty breathing.

Recommendations – The FDA has determined that Actos® and all drugs in the classification of thiazolidinediones may cause or worsen incidents of congestive heart failure. Patients with a history of heart failure should not be prescribed Actos®. Physicians should monitor patients after prescribing or changing the dose of Actos®. If symptoms of heart failure develop, appropriate steps should be taken, including the consideration of discontinuing Actos® treatment.

Actos® and Bladder Cancer

The second FDA revision to the official prescribing information for Actos® did not occur until August 2011, but notices concerning a possible safety issue concerning an increased risk of bladder cancer were issued in September 2010. The notice was made after preliminary reports from the halfway mark of a 10-year study on Actos® and bladder cancer were analyzed by the FDA.

The FDA announced in June 2011 that the safety notice would be upgraded to an official warning and information about the risk of developing bladder cancer would be added to the official label for Actos®. The upgrade of the notice to a warning was made after further analysis of the preliminary reports from the 10-year study and analysis of a study in France that corroborated the evidence. Based on the French study, France has suspended the use of pioglitazone and Germany has issued a stern recommendation advising physicians against its use.

Patient Information – Patients should be informed of an increased risk in developing bladder cancer due to taking Actos®. Patients should not take Actos® if they are currently being treated for bladder cancer or have a history of bladder cancer. A physician should be notified in the event of any symptoms of bladder cancer. These symptoms may include blood in the urine, discolored urine, frequent or urgent need to urinate, pain while urinating, pain in the lower back, and abdominal pain.

Recommendations: Physicians are warned not to prescribe Actos® to patients with bladder cancer and discontinue use if bladder cancer develops while taking Actos®. Actos® must be used cautiously for patients with a history of bladder cancer, and the benefits of Actos® should outweigh the risks of a recurrence of the cancer. Adverse events in patients taking Actos® should be reported to the FDA through the MedWatch program.


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