Actos is a prescription diabetes medication used by millions of patients around the world. As with any prescription medication, there are a number of side effects associated with Actos. Unfortunately, one more has recently been added to the list. The FDA has issued a statement warning patients that Actos may increase their risk of bladder cancer.
All details herein provided for informational and educational purposes only, contact experienced Actos attorneys for additional information.
Why the FDA Warned the Public
The FDA issued their warning after reviewing data from an ongoing 10-year study performed by Takeda Pharmaceuticals. This study, which was review at its halfway point, is dedicated to testing the long-term effects of Actos on users. After reviewing the collected data, the FDA has found that people exposed to Actos for a prolonged period are at an increased risk of developing bladder cancer. As many are aware, bladder cancer is a serious form of cancer that kills thousands each year.
However, using Actos does not necessarily increase a patient’s risk of bladder cancer. Instead, prolonged exposure, of one or more years, is what increases patients’ risk. High doses of pioglitazone, which is the drug’s active ingredient, may also put a patient at a higher risk.
As of July 11, 2011, France and Germany have suspended the sale of Actos. Due to the new concern, the European Medicines Agency and the FDA are reviewing the safety of the drug. While a decision has not yet been made on whether to suspend Actos, patients are warned that they may be putting themselves in danger.
What This Warning Means for Actos in the Future
Actos is not the first drug in its class to be linked to serious side effects. Avandia, which also belongs to the thiazolidinedione class, was recently put on strict restrictions. Avandia was found to increase patients’ risk of heart attack, which forced the FDA to restrict its use to patients that were unresponsive to Actos.
These restrictions and concerns have many people wondering what will be done with Actos in the future. Many believe that physicians will be less likely to prescribe Actos to their patients. Patients may also be less willing to take the drug due to concerns over the possible side effects. Of course, that is assuming that the drug is not recalled, as it has been in France and Germany.
The future of Actos will become clear as the FDA continues to study the drug. The study that raised these concerns is currently ongoing, which means that more information will be made available in the future. Until the FDA knows more, patients and physicians must decide whether the benefits of Actos are worth the potential risks.
Goldberg & Osborne, a personal injury law firm, has provided this article for informational purposes only, written by an independent author, and has not reviewed or edited this article and is not responsible for its content or accuracy.