FDA approved Actos in the year 1999, on July 16th. It was sanctioned as an oral treatment for type II diabetic patients. This approval was based on a review of data that was compiled from 6 U.S. double- blind, placebo controlled studies. These studies were conducted on more than 4,500 patients suffering from type II diabetes. During these studies the results were amazing in comparison to other similar drugs. Actos produced statistically significant reduction in the glucose levels of blood, in almost all of the monotherapy trials and in the combination trials with insulin, metformin or sulfonylureas.

Then in the year 2007, FDA issued an alert which highlighted important revisions to the full prescribing information of Actos. This updated information included a “Boxed Warning” and some additional Warnings and Precautions that were updated to emphasize and educate the practitioners and consumers about the chances of heart failure that the drug may cause. This update was done post FDA’s analysis of the drug related data.

Following this alert, in the year 2011, FDA informed the public that using Actos for more than a year can cause bladder cancer. It was stated that all the Warnings, Precautions and even the Medication Guide will be updated to incorporate this piece of information. FDA carried out a ten year epidemiological study and during this study, a five year interim analysis and the data summary suggested that the increased risk of bladder cancer was amongst patients with either a long exposure or high amount of cumulative dose of pioglitazone. The agency was also conscious of the epidemiological study conducted in France, which also indicated a higher risk of bladder cancer with pioglitazone. France as a result of this study banned this medicine and Germany made a rule not to start with this medicine as a new prescription.

FDA had certain recommendations for all the healthcare professionals and Patients.

For instance, the recommendations for healthcare professionals included not to prescribe pioglitazone to patients with either active bladder cancer or with a previous history of bladder cancer. The practitioners should educate the patients effectively to keep a tap on the symptoms of bladder cancer like blood in the urine, urinary urgency, pain on urination, or back or abdominal pain. Thirdly, the patients should read the medication guide thoroughly to understand the benefits and repercussions of the drug. And lastly, report any kind of adverse events related to the drug to the FDA MedWatch program.

The recommendations for patients included not to take this medicine if undergoing the treatment of bladder cancer. Keep a close watch on any of the following symptoms as these could be one of the symptoms of bladder cancer:

  • Blood in urine
  • Urinary urgency,
  • Pain on urination, or
  • Back or abdominal pain

The medication guide provided with the drug should be read well by the patients before consuming the drug, to understand the pros and cons of the medicine. Serious side effects should be reported to FDA Med Watch program at the earliest.