Various Governments Withdraw Actos, Issue Warnings

In 2008, the drug Actos was the tenth-bestselling drug in the United States, brining in over 2.4 billion dollars in revenue. The drug works by altering the transcription of insulin-sensitive genes, reducing insulin resistance. This helps diabetics control their blood sugar. It has also been found to reduce the risk of pre-diabetes converting to full-blown type-2 diabetes. Additionally, Actos originally appeared to cause fewer serious side effects than some similar diabetes drugs. However, these benefits could be offset by the risk of life-threatening bladder cancer.

Evidence of Actos Bladder Cancer Mounts

However, evidence is mounting that Actos may be associated with an increased risk of bladder cancer. First, in 2011, the French Agency for the Safety of Health Products withdrew Actos from the market in France, based on concerns stemming from an epidemiological study that found a link between Actos and an increased risk of bladder cancer. The same year, Germany’s Federal Institute for Drugs and Medical Devices advised doctors not to prescribe the drug to new patients until the risk of cancer could be more thoroughly studied.

In the United States, the Food and Drug Administration (FDA) has issued safety information advising physicians to not use Actos in patients with active bladder cancer, and use caution in patients with a history of cancer. The FDA is still evaluating an ongoing epidemiological study, but have already collected five years’ worth of data. The preliminary data has indicated that Actos is linked with a 40 percent increase in the risk of bladder cancer. Based on this FDA has already added warnings to the information included with the drugs. The link between Actos and bladder cancer appeared to be linked with dosage and the length of time the patient took the drug.

The FDA has not recommended that patients currently taking Actos to stop using the medication without consulting their physicians, but they have advised that patients and their physicians watch for early warning signs associated with bladder cancer. These symptoms include pain when urinating, frequent urination, blood in their urine, and pain in the back or abdomen. Patients experiencing these symptoms should immediately consult their primary care physicians. The FDA has based these concerns on their own ongoing study, as well as the French National Health Insurance Plan’s epidemiological study, the same study that led to the drug’s withdrawal in France.

Multi-district litigation has been created to handle the growing number of drug injury lawsuits filed against the manufacturers of Actos. These lawsuits allege that the manufacturer knew, or should have known that Actos could potentially cause cancer. The Actos lawsuits further allege that the manufacturer downplayed these risks, preventing patients and prescribing physicians from having the information they needed to make an informed decision regarding their medical care. Plaintiffs are seeking damages related to medical problems suffered after using Actos.