Actos Side Effects
Actos, also known as pioglitazone hydrochloride, is a prescription drug in the thiazolidinedione (TZD) class. It is used to treat diabetes mellitus type 2, or non-insulin-dependent diabetes mellitus (NIDDM), and works by increasing the body’s sensitivity to available insulin.
Actos has been available in the United States since 1999, when the Food and Drug administration (FDA) first approved it for use. In 2008, it was the tenth-bestselling medication on the U.S. prescription drug market. While it was originally thought to be a comparatively safe alternative to other TZD drugs, Actos has since been linked to serious side effects, among them heart failure, Actos bladder cancer, and bone fractures.
Actos Heart Failure
In 2005 on Actos side effects, a study published in the Lancet revealed that high-risk patients taking Actos showed a high risk of heart failure. Later, a separate study concluded that almost 10 percent of patients taking Actos had experienced congestive heart failure resulting in overnight hospitalization; patients taking comparable medications (glyburide, for example) had only a 5 percent rate of congestive heart failure.
In 2007, the FDA ordered Takeda Pharmaceuticals, the manufacturer of Actos, to include a black-box warning on its product. The warning explained that Actos could cause congestive heart failure, as well as edema and fluid retention.
Actos Bladder Cancer
In 2010, the FDA began analyzing data collected by Takeda Pharmaceuticals. The FDA took into account the first five years of data in a ten-year Actos safety study, and concluded that there was a positive link between the drug and bladder cancer: Study results showed that patients who had taken Actos for more than a year, or who had taken high dosages, had a 40 percent greater risk of bladder cancer. On June 15, 2011, the FDA issued a public warning regarding Actos and its association with bladder cancer.
The first Actos bladder cancer lawsuit was filed in August 2011. Many are expected to follow.
Actos Bone Fractures
In 2007, the FDA also warned consumers and doctors that Actos incurred an increased risk of bone fracture in the hands, feet and arms for female patients. In 2010, the Journal of Clinical Endocrinology & Metabolism published a study that supported this warning, concluding that Actos patients, especially postmenopausal women, had an elevated risk of bone fracture.