Is Actos Safe for the Treatment of Diabetes?

Recent Actos news, including an FDA warning about side effects, has many diabetes patients asking, “Is Actos safe for me to take?”

Diabetes Drug Actos Used to Lower Blood Sugar

The FDA approved Actos (pioglitazone) in 1999 for the treatment of type 2 diabetes. In a class of drugs called thiazolidinediones, Actos works to increase the body’s sensitivity to insulin, thereby helping to control blood sugar levels.

Like many drugs, Actos comes with some side effects. Minor ones include headache, muscle pain, sore throat, and indigestion. More serious Actos side effects, however, like heart failure and bladder cancer, have led some to believe that Actos may not be safe.

Is Actos Safe? France Says “No”

In 2007, the FDA required a black-box warning on Actos alerting the public to its potential to cause or worsen congestive heart failure. A scientific study reviewing data from 20,000 patients with type 2 diabetes or pre-diabetes, published in Lancet, found the risks were highest for those patients with a history of heart disease and heart failure, and less for those who had no heart problems.

The serious warning helped physicians make informed choices for their patients, but the benefits of the drug were still considered to be greater than the risks”until 2011. After reviewing the data from an ongoing 10-year epidemiological study, the FDA announced that Actos is associated with an increased risk of bladder cancer. The French Medicines Agency had reviewed research of their own that showed similar results. They took it more seriously, and actually implemented an Actos recall.

What Dose of Actos is Safe?

Is Actos safe? The FDA seems to still think so, though they’re continuing to review the data. They warned about the risk of Actos bladder cancer, but they did not indicate that they would be pursuing a recall. Instead, the agency stated they will continue to evaluate data from the ongoing 10-year study, and will also review the results of the French study. After that, if they come up with any new information, they will provide updates at that time.

Meanwhile, patients may wonder: What dose of Actos is safe? According to the FDA review, Actos didn’t increase the risk of bladder cancer overall. Instead, those who took the drug for more than a year, or who took high doses, experienced a 40 percent greater risk. As a result, patients may want to discuss with their healthcare practitioners ways to limit their use of the drug to less than one year. Actos is available as a 15 mg, 30 mg, or 45 mg tablet, so taking the smallest dose possible might also help reduce risk.

Bottom Line: Is Actos Safe?

Whether or not Actos can be deemed “safe” or not still remains to be seen. As the FDA stated, more research needs to be completed before anyone can say for sure what the real risks are. In the meantime, those with heart disease or a history of cancer may want to ask their doctors about alternative types of treatments. Individuals who have already taken Actos and experienced serious Actos side effects may want to consider legal counsel in order to recover medical expenses.

An Actos Lawyer May be Able to Help

If you or a loved one has suffered from an injury caused by Actos, 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.