Actos Side Effects
Initially approved by the FDA in 1999 to treat diabetes, Actos has been found in studies to increase the risk of several serious side effects, including heart failure, fractures, and most recently, bladder cancer.
Actos (pioglitazone hydrochloride) belongs in the class of thiazolidinedione (TZD) drugs, which help control blood sugar levels in patients with diabetes. It works by helping the body’s cells become more sensitive to the insulin available.
Actos bladder cancer
On June 15, 2011, the FDA released a new warning concerning Actos bladder cancer. The agency has been following the potential link for a while, announcing in 2010 that they were looking into it. Prior to releasing the 2011 warning, they analyzed data from the first five years of a ten-year Actos safety study conducted by the manufacturer, Takedo. The data showed that risk of Actos bladder cancer was 40 percent higher in those patients taking the medication for longer than a year, or who had the highest cumulative dose.
A study in France also suggested a link between pioglitazone and bladder cancer. Both France and Germany later suspended sales of the drug.
Actos heart failure
A 2005 study published in the Lancet found that patients in a high-risk group taking Actos had an increased risk of heart failure. A later post-marketing safety study found that nearly 10 percent of patients on Actos experienced overnight hospitalization for congestive heart failure, compared to nearly 5 percent of patients on a comparable medication (glyburide).
In 2007, the FDA required a black-box warning for all pioglitazone hydrochloride medications, including Actos, alerting the public to the possibility that the drug could cause or exacerbate congestive heart failure, particularly in certain populations. Updated label information also warned of Actos fluid retention and edema, which can exacerbate or lead to heart failure. Critics complained the warning was late, however, since Dr. John Buse, who served as president of the American Diabetes Association, warned about the cardiovascular risks as early as 1999.
Though some later studies implied that Actos had a lower risk of heart problems than similar diabetes drug, Avandia (also a TZD drug), a 2010 study published in Circulation: Cardiovascular Quality and Outcomes found that the heart risk from Actos was just as great as that from Avandia.
Actos limb fractures
Along with concerns about Actos heart failure, the FDA also informed physicians in 2007 about an increased risk of arm, hand, and foot fractures among women taking the drug. In 2010, another study published in the Journal of Clinical Endocrinology & Metabolism again found an increased risk of fracture in patients taking Actos. The risk was particularly high in postmenopausal women. Those suffering from factures were 70 percent more likely to be taking a TZD drug.
Actos lawyers pursuing Actos lawsuits
According to The Washington Post, the first Actos bladder cancer lawsuit was filed in August of 2011. The FDA warning will likely increase awareness and result in more Actos lawsuits to follow. Actos lawyers are expected to claim that Takeda failed to adequately warn about the serious side effects.
Meanwhile, about 13,000 Avandia lawsuits have been filed across the country. Avandia is linked with similar side effects including heart failure and bone fractures.