The FDAs Many Updates Regarding Actos
Approved by the U.S. Food and Drug Administration on July 16, 1999, Actos, manufactured by Takeda Pharmaceuticals North America, was sanctioned as an oral treatment in conjunctions with diet and exercise for type II diabetic patients who are not insulin dependent. Approval was based on a review of data compiled from six studies. In these studies, more than 4,500 patients suffering from type II diabetes showed amazing results in comparison to those using similar drugs; they illustrated statistically significant reduction in the glucose levels of blood in almost all of the monotherapy and combination trials.
Yet, these amazing results proved too good to be true. Soon after its approval, the FDA was made aware of serious side effects as a result of Actos use through countless testimonials reported to the FDA’s Adverse Events Reporting System (AERS), a database containing information on harmful events and medication error reports. AERS, employed by the FDA in order to identify new safety concerns and evaluate a manufacturers’ compliance to rules and regulations, is strictly voluntary for healthcare professionals, such as doctors, nurses, and pharmacists, and consumers, including users and their family members—anyone who experiences an adverse effect from a medication can file a report with the AERS. However, if an adverse event is sent to the manufacturer, they are obligated to forward the information to the AERS. The FDA then utilizes these adverse event reports as a way of overseeing the safety of a product on the market. Based on the repeated reporting of excessive and rapid weight game, lack of endurance and shortness of breath by Actos consumers, the FDA issued its first alert in regards to Actos use and heart failure in August 2007. In addition to a public alert, significant revisions to the prescribing information of Actos were also to be made: a boxed warning, the strongest warning the FDA issues, and new wording in the Warnings and Precautions section of the medication insert. The new label and insert now included the phrase “may cause or exacerbate heart failure.”
Then, on September 17, 2010, the FDA notified healthcare professionals and current patients of another terrible and life-threatening side effect of Actos consumption: bladder cancer. The FDA stated it was conducting a “safety review” after Takeda submitted results at the half-way mark of an on-going, ten year epidemioloical study, running from January 1, 1997 through April 30, 2008. The manufacturer reported no statistically significant association between Actos and bladder cancer, yet the FDA determined the study did indicate an increased risk in those using Actos long term (for more than one year) and that further study was needed.
Less than nine months later, in June 2011, the FDA, based on an independent French study, announced that the “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer” and required another label and Warnings and Precautions update. The French study following 1.5 million patients enrolled in the French National Health Insurance Plan for four years (2006-2009) and found a statistically significant increased risk of long-term use (more than one year) and bladder cancer and an increased risk of higher cumulative dosing (28,000 mg or greater) and bladder cancer. The European community took this study seriously and acted immediately. John Gever, Senior Editor at MedPage Today, reported on June 10, 2011, that the French study was completed on a Tuesday, use of Actos in France was suspended the following Thursday, and by that Friday, Germany had followed suit and also halted use in new patients.
During this same time period, the FDA, on January 31, 2011, in its quarterly list of investigations following the reporting period from July-September 2010, once again identified Actos as a “potential safety issue;” this time in regards to liver damage as a result of rhabdomyolysis, the release of muscle fibers into the blood stream. At the time of this statement, the agency did not consider Actos a risk, but identified it as a potential link that needs further study.
The FDA has certain recommendations for all the healthcare professionals and patients.
Healthcare professionals should not prescribing Actos or any pioglitazone-type product to patients with either active bladder cancer or with a previous history of bladder cancer and should educate patients about monitoring for the symptoms of bladder cancer like blood in the urine, urinary urgency, pain on urination, or back or abdominal pain.
Patients should not take this medicine if undergoing the treatment of bladder cancer, should read the medication guide thoroughly to understand the benefits and repercussions of the drug, and should keep a close watch on any of the following symptoms as these could be one of the indications of bladder cancer:
- Blood in urine
- Urinary urgency,
- Pain on urination, or
- Back or abdominal pain
Both healthcare professionals and patients should report any kind of adverse events related to the drug to the AERS.
Have You Been Affected by Actos?
Any individual or the relative of an individual who has suffered due to Actos’ side effects is permitted to file a lawsuit. The lawyers can help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered). If you need further information about the harmful side effects of Actos or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.