FDA's Role With Actos

The FDA Is Not a Guarantor of Drug Safety

Many people assume that approval by the federal Food and Drug Administration (FDA) means that a drug is safe. Unfortunately, that is not true. The FDA does not test anything. Rather, it gets information supplied by the manufacturers and makes its approval decisions based on that information.

Drug approval based on data from the drug companies

In the case of the diabetes drug Actos (pioglitazone) as with other cases, the FDA relied on information provided by the manufacturer, Takeda. The FDA simply does not have the testing facilities or the personnel to assure that every drug is properly tested for safety and effectiveness, and FDA safety alerts are usually based on the findings of external labs and agencies.

FDA issues Actos safety alert

However, in 2011 the FDA did require Takeda to take part in a 10-year study of the side effects of Actos as a result of pre-approval indications that Actos caused an increased rate of tumors in male laboratory rats who were given a dose equivalent to the prescribed human dose. The five-year interim review of results showed that the risk of bladder cancer increases with increasing dose and duration of Actos use. As a result, the agency issued an Actos FDA warning and required Takeda to include information about this risk on the label. As yet, however, there has been no Actos FDA recall.

The only language Takeda seems to fully understand is money. That is why the lawyers of Girardi | Keese have filed suit against the company. If you have a client, patient or family member who has been harmed by Actos, contact us to speak with a California attorney about the Actos lawsuit.