Ensuring Unsafe Drugs Are Restricted – The Actos Example

Popular drugs are not necessarily safe. It is the work of experienced drug recall lawyers that helps uncover the dangers posed by these drugs and opens the eyes of the FDA and the general public. This is what happened in the case of the diabetes drug, Actos.

Actos rose to prominence in 2007 as the best-selling drug to combat diabetes. Its chief rival, Avandia, was found to increase the risk of heart attack. The effectiveness of Actos is due to its active ingredient pioglitazone that increases the sensitivity of the body to insulin, a natural hormone for controlling blood sugar. Both Actos and Avandia are from the same family of drugs, called TZDz (thiazolidinediones).

Actos was approved by the FDA in 1999 and was subsequently launched in the market. However, clinical studies conducted later showed an increased percentage of bladder cancer when humans or animals consumed the drug regularly. Takeda Pharmaceuticals, manufacturer of Actos, conducted further research lasting for up to 10 years to investigate the connection between the drug and bladder cancer. Within the first five years of the research, an increased risk of bladder cancer was proved. The efforts of drug recall lawyers were significant in leading the manufacturer to conduct the research.

The drug has already been banned in Germany and France but the U.S. has yet to follow suit. The results of the research conducted by the French Medicines Agency indicated that people consuming the Actos diabetes drug have a 22 percent greater incidence of bladder cancer than those consuming other diabetes medication. The European Medicines Agency (EMA) is presently conducting its own review of the drug’s safety and claims that in some circumstances, the drug is safe.

The FDA is evaluating results from the study conducted by Takeda Pharmaceuticals, as well as those from an exhaustive French epidemiological study that surveyed around 1.5 million individuals with diabetes. The study was conducted over a period of four years and revealed a significant rise in bladder cancer risk for patients consuming pioglitazone, the active ingredient in Actos, when compared to the other diabetes drugs.

Prior to recalling a drug, the FDA needs to prove the existence of a reasonably significant probability of that drug to cause death or some serious health consequences. The drug was recalled in France in 2011. The FDA already issued advisories to Actos patients and healthcare professionals. It also provided updated safety information on the label of the drug, explaining that consuming pioglitazone for more than a year could increase the risk of bladder cancer.

The FDA is currently asking patients with active bladder cancer not to consume pioglitazone and patients with a history of bladder cancer to use it with caution.

Legal action continues to mount against the manufacturer of Actos, thanks to the efforts of drug recall and personal injury attorneys. There are already at least 10,000 lawsuits in the U.S. against the two manufacturers that originally marketed Actos. Though Actos has not been officially recalled by the FDA, patients injured by the drug can still seek compensation.

These lawsuits have already resulted in the pharmaceutical company losing significant earnings as Actos began losing market share to other diabetes drugs. It contributed to about 20 percent of the manufacturer’s revenue, so the 46.2% decline in sales from 2011 led to the manufacturer’s stock falling to an 11-year low.

Experienced Actos attorneys at Pintas & Mullins Law Firm can explain your legal rights if you or a loved one were diagnosed with bladder cancer or experienced other serious Actos side effects.