The FDA approved diabetes drug Actos in 1999, but since then, post-marketing studies and analyses have revealed greater Actos dangers than originally reported, including an Actos cancer risk. If you’re taking this drug to help control your blood sugar, it pays to be aware of the potential Actos dangers.
Early Actos Dangers Included Risk of Heart Failure
The first of many Actos dangers that received a great amount of attention was Actos heart failure, indicated in a 2005 study published in Lancet. Patients in that study had an increased risk of heart failure, as well as edema and weight gain. A post-marketing study also found that overnight hospitalization for congestive heart failure occurred in 9.9 percent of patients on Actos.
In 2007, the FDA required that manufacturer Takeda update their product information to include a black-box warning alerting patients to the risk of congestive heart failure, fluid retention, and edema. A later study in 2010 published in Circulation confirmed the risk of Actos dangers to the heart.
Actos Cancer Danger Confirmed in 2011
Meanwhile, early studies indicated the possibility of a link between Actos and bladder cancer. An early animal study found tumors in male rats that received the drug at doses equivalent to clinical doses in humans. In 2005, a three-year study on Actos implemented to examine Actos dangers like heart failure, found a statistically significant Actos cancer risk as well. In September 2011, the FDA announced it was looking into the issue.
In April 2011, the American Diabetes Association published a study that again indicated an Actos cancer danger, and they recommended more studies. In June, the drug was recalled in France due to Actos cancer risk, and on June 15, 2011, the FDA warned the public and healthcare professionals of the risk of Actos bladder cancer. For patients taking the drug longer than a year, or at high doses, the increased risk was as high as 40 percent. The FDA suggested physicians carefully monitor their patients, and refrain from prescribing Actos to those with a history of bladder cancer.
Other Actos Dangers
Though heart failure and Actos bladder cancer are the more serious Actos dangers, the diabetes drug also has been linked to a rare condition called rhabdomyolysis. This condition results in muscle deterioration, weakness, aches and pains, and left untreated, can lead to kidney failure. So far the FDA has yet to establish a direct link between Actos and rhabdomyolysis, but they have warned that the drug is associated with the risk.
Actos dangers also include arm, hand, and foot fractures, which are particularly concerning in post-menopausal women. The FDA informed physicians about this risk in 2007, and a later 2010 study confirmed the risk.
An Actos Dangers Lawyer May be Able to Help
If you or a loved one has experienced an injury as a result of Actos dangers, you may be eligible for compensation in an Actos lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.