Classified as a thiazolidinedione drug and generically referred to as pioglitazone, Actos is an oral medication prescribed to treat type-2 diabetes. By improving the body’s ability to respond to insulin, Actos can effectively help diabetic patients improve their control over their blood sugar levels when taken in conjunction with regular exercise and a healthy diet. In the U.S., Actos is produced by the Takeda Pharmaceutical Company (and co-marketed by Eli Lilly Pharmaceuticals) and was the tenth most popularly sold drug in 2008 (with earnings of more than $2.4 billion).
Actos Side Effects
Research indicates that, despite being effective at treating type-2 diabetes, Actos can increase patients’ risk of sustaining congestive heart failure (CHF), a condition in which the heart is unable to pump enough blood to meet the body’s needs due to a heart attack, cardiac arrest, or some other trauma. Actos has also been reported to cause hypoglycemia and anemia.
In 2010, Takeda Pharmaceutical Company released preliminary data that indicated that Actos could be linked to the development of bladder cancer in some patients. Following the release of these initial findings, the Food and Drug Administration (FDA) ordered a safety review for Actos in September of that same year.
Actos Black Box Warning
In June 2007 during a hearing of the U.S. House of Representatives, the FDA announced that it was mandating Black Box warnings on all Actos packaging and advertising. These Black Box warnings, the most serious warning label issued by the FDA (and the last step before the drug is recalled), were aimed at highlighting the risks of sustaining serious, life-threatening heart injuries as a result of taking Actos.
While it seems as though the FDA has taken adequate measures to respond to the dangers of Actos, before mandating Black Box warnings for Actos in 2007, the FDA had two strong warnings from industry leaders regarding serious, potentially fatal, Actos side effects. In 1999, Dr. John Buse, the president of the American Diabetes Association, highlighted the heart-related dangers associated with Thiazolidinediones. Despite Dr. Buse’s prominence and the weight of his warning, no action was taken to investigate Actos side effects. The second warning came from an FDA safety advisor, Dr. Rosemary Johann-Liang, who urged that the FDA mandate Black Box warnings for Actos.
Such negligence likely increased the number of patients who sustained Actos heart problems, and those who have been injured may have a compelling case against Takeda Pharmaceuticals. Actos lawsuits are defective drug cases focused on securing the maximum possible compensation for the losses and injuries of those who have suffered from serious Actos side effects.
If you or a loved one have used Actos and suffered from any side effect including heart disease, congestive heart failure, severe allergic reaction, liver damage, or diabetic ketoacidosis you should contact our Actos lawyers immediately for a free and confidential case review. You may be entitled to compensation and we can help.