Sunday, January 15, 2012

Actos® FDA Safety Review/Warning

On June 15, 2011, the United States Food and Drug Administration informed the public that using the drug Actos, commonly prescribed in the treatment of Type 2 diabetes, has been positively associated with an increased risk of bladder cancer. Actos is manufactured by a Japanese pharmaceutical company, Takeda Pharmaceuticals, and is typically sold either as a single-ingredient product or in combination with the drug metformin. Actos is prescribed, along with diet and exercise, to help control blood sugar in adults. Initially the FDA’s safety warnings were based on a five-year interim analysis of an ongoing ten year study regarding the risks for those taking Actos.

While the study at the five-year mark noted an increased risk of bladder cancer among those who had taken Actos in the highest dosages and for the longest periods of time, it was unclear about the overall increased bladder cancer risk. Two other countries, France and Germany, have taken more definitive actions regarding Actos, believing it poses serious health risks. While France has suspended the use of Actos altogether, Germany has recommended to physicians that they not start new patients on the drug. New Zealand is currently in the midst of recalling the drug, yet the FDA continues to maintain that further study is warranted before issuing more stringent warnings.

Summary of the Ten-Year Study
The study the FDA is basing their opinions on was actually conducted by Takeda Pharmaceuticals, the manufacturer of Actos. Takeda simultaneously conducted case-control studies on patients with Type 2 diabetes who were also members of Kaiser Permanente Northern California health plan. The participants in these studies were over the age of forty at the onset of the study, and any patients who had been diagnosed with bladder cancer prior to the study were excluded.

The larger cohort study included over 190,000 patients and the median duration of the Actos therapy was two years, with a range of three months to eight and a half years. Once the study was adjusted for age, sex, use of tobacco products as well as the use of other diabetes drugs it showed no significant increase in bladder cancer risk for those simply “exposed” to Actos. On the contrary, the risk appeared to increase significantly in those taking the drug for longer than twelve months or in higher dosages—as much as a 40% increase in the risk of bladder cancer.

French National Health Insurance Plan Study
The FDA also took a passing look at another cohort study conducted by the French National Health Insurance Plan which included approximately a million and a half patients with Type 2 diabetes and lasted for four years. After the normal adjustments for age, sex, and the use of other anti-diabetic medications, the French study showed a significant increase in the risk for patients taking Actos to contract bladder cancer as compared to other anti-diabetic drugs. The French study correlated a cumulative dosage of more than 28,000 mg of Actos or exposures of longer than twelve months with a significantly elevated risk of bladder cancer.

FDA Concerned With More Than Consumer Safety?
There is some speculation that our FDA is a bit too cozy with huge drug companies and is perhaps more concerned with corporate profits than consumer safety. One non-profit consumer advocacy group known as Public Citizen has gone head to head with the FDA time after time, believing the agency is too slow to recall defective drugs or issue appropriate warnings. This belief stems from the fact that governmental agencies in other countries typically ban drugs believed to be harmful or at least issue appropriate warnings much sooner than the FDA does.

How the Warning Label has Changed
In 2002 the FDA required that the Actos label carry the warning that when combined with insulin a small number of patients with existing cardiac disease were found to develop congestive heart failure. In 2004, the warning label was changed to add carcinogenesis, mutagenesis and impairment of fertility to the list of precautions. On August 4, 2011, the FDA approved major changes to the warnings and precautions section of the Actos label to include the increased risk of bladder cancer, and cautioned doctors to refrain from prescribing Actos for those patients with a history of bladder cancer.

Patient Warnings for Actos
Physicians are advised to not only be cautious in prescribing Actos for those with a history of bladder cancer, but to be vigilant in issuing relevant warnings to their patients. Patients should be advised to contact a medical professional immediately if they experience any symptoms of bladder cancer including blood in the urine, pain while urinating, urination urgency or pain in the lower abdomen or back. Patients should additionally be encouraged to read the entire medication guide received with their prescription of Actos, and physicians must report any adverse events in their patients using Actos to the FDA.

Author: Sullo & Sullo Attorneys

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