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FDA Issues Warning About Risks of Diabetes Drug Actos

This past July, the Food and Drug Administration (FDA) warned users that taking the diabetes-treating drug Actos for more than one year could increase their risk of developing bladder cancer. The FDA issued the warning after reviewing the midpoint data of a ten-year study of the drug.

According to MedPage Today, the 10-year FDA study began in 2002 and the midpoint review includes data on over 193,000 patients taking the drug. The results, which the FDA say are of "nominal" statistical significance, show that the use of Actos, compared to non-use of the drug, increased the number of incidences of bladder cancer of 27.5 per 100,000 people.

While the results of the data at the five-year point of the study were sufficiently alarming for the FDA to issue the warning, a recall of the drug was not made in the United States and doctors are still able to prescribe Actos-which, according to Bloomberg, is the best selling diabetes-treating medication in the world-to diabetes patients.

However, according to an article on PRWeb, the drug's use was banned by French and German authorities after a study of Actos was conducted by the French Medicines Agency (FMA). Like the early results of the FDA study, the FMA study found that using Actos increased the risk of developing bladder cancer. In fact, the study found that the using Actos for more than one year increased this risk by approximately 40 percent.

Bladder cancer, according to the Mayo Clinic, is very treatable when caught early; however, even after being successfully treated, it is likely to redevelop. The National Cancer Institute estimates that in 2011 there have been over 69,000 new cases of bladder cancer (with vastly more men than women developing the cancer) and an estimated 15,000 people dying from the disease.

Not the First Dangerous Diabetes Drug

This is not the first time that a diabetes-treating drug has been linked to adverse health issues. Avandia, a competitor of Actos, was linked to an increased risk of heart attack in patients in recent years. Both drugs are of the same medication class, thiazolidinedione (TZD).

In September 2010, special restrictions on the use of Avandia were issued by the FDA, and the drug was banned from sale in Europe. According to a study reported in the New York Times, there were an estimated 47,000 Avandia-related fatalities between 1999 and 2009.

After the side effects of Avandia began to surface, a large number of personal injury lawsuits were filed against the drug's manufacturer. And, the same may be true of the manufacturer of Actos if people continue to develop complications such as bladder cancer.

Dangerous Drug Lawsuits

Drug manufacturers are required to conduct safety testing of all new drugs prior to approval for use by the FDA. However, pre-approval testing sometimes results in questions about trial data, which is one of the reasons for the continued studies of Actos by the FDA.

When people are injured by a drug that was not fully tested by the drug manufacturer or patients are not fully warned of the potential risks of taking the drug, people may be entitled to compensation against the drug manufacturer for their injuries.

A Drug Manufacturer's Liability

In order to show that a drug manufacturer was negligent, an injured patient must prove:

  • The manufacturer had a duty to exercise reasonable care in the process of manufacturing the drug;
  • The manufacture breached that duty;
  • The breach of that duty was a causal factor in peoples' injuries, and
  • People actually suffered injuries.

If You Have Been Injured...

Even though the FDA has issued a warning about the risks involved in taking Actos, do not stop taking it-or any other prescription drug-without first talking with your doctor. By discontinuing your diabetes medications (Actos) without first speaking with your doctor and establishing a new regimen to treat the disease, you could be putting yourself at risk of serious health complications.

Personal injury lawsuits involving drugs are very complex; therefore, if you have developed bladder cancer or any other adverse health effect after taking Actos, speak with an experienced personal injury attorney in Texas about seeking compensation for your medical bills and pain and suffering. Because there is a statute of limitations on bringing a claim against a drug manufacturer, it is important to discuss your situation with an attorney soon after learning that you are suffering from adverse side effects of a drug.