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Actos® is a drug prescribed to treat Type II Diabetes. It was originally approved for use by the Food and Drug Administration (FDA) in 1999. The primary ingredient in Actos, pioglitazone, increases the body’s sensitivity to the hormone insulin, which helps naturally regulate blood sugar levels. Combined with diet and exercise, it was believed that Actos could help patients with Type II Diabetes better control and manage their condition.
Risks Associated with Actos
Multiple studies by the FDA concluded that Actos® can, in fact, lead to serious and potentially deadly side effects in patients.
One of the most dangerous side effects of this medication is that Actos has been closely linked to an increased risk of bladder cancer in patients. In 2011, the FDA concluded that using the drug Actos for a period of 24 months or longer correlated to roughly a 40% increase in a patient’s risk of developing bladder cancer.
Other serious and potential side effects of Actos include:
Increased risk of congestive heart failure
Eye disease and eye swelling is also known as Macular Edema
Increased risk of bone fractures in female patients
Liver and kidney disease and failure
Warnings to Patients
Actos was never officially recalled from the U.S market, despite the many known dangers and risks it posed to patients.
In 2007, Actos received a Black Box warning from the FDA. This boxed warning label alerted patients about the potential increased risks of developing congestive heart failure while taking the medication; however, this Actos warning label made no mention of the increased risk of bladder cancer.
In 2010, the FDA finally issued a formal safety announcement about Actos and the associated risks of patients developing bladder cancer. The FDA announced that after conducting a ten-year study on the drug, they had determined that higher levels and longer periods of exposure to Actos had a strong link to bladder cancer.
Despite these multiple red flags about the safety of this drug, Actos remained available to patients in the United States, even after it had been deemed unsafe and recalled in other major markets such as Germany and France.