The United States Food & Drug Administration and the European Medicines Agency have issued urgent safety alerts regarding the type-2 diabetes drug, Actos® (pioglitazone). Analysis of clinical studies in both the United States and Europe have revealed an increased risk of bladder cancer among patients prescribed Actos®. If you have been taking this medication, you may have a viable claim and you need to speak with a mass tort attorney before it is too late.
On June 15, 2011, the FDA issued an urgent health warning to doctors and patients that Actos® could increase the risk of bladder cancer by as much as 40 percent. Long-term users of Actos® and those exposed to higher cumulative doses are among those at the greatest risk.
The FDA now requires that information about this increased risk be added to the “Warnings and Precautions” section of the label for Actos® and other pioglitazone-containing medicines. However, the agency has stopped short of issuing an Actos® recall. The FDA “stresses that there is no definitive proof that Actos® causes bladder cancer and that patients who are currently taking it should continue to do so unless otherwise advised by their healthcare provider.”
In June 2011, French authorities decided to suspend the use of pioglitazone-containing medicines such as Actos® after a four-year study of 1.5 million diabetics found a 22 percent increased risk of bladder cancer among patients who had ever been exposed to the drug. Patients prescribed the drug for more than a year had a 34 percent increased risk of developing bladder cancer, and those exposed to the highest cumulative doses had a 75 percent increase in risk.
The finding of the French study has prompted the European Medical Association to implement an immediate review of the safety of Actos® across the entire European Union. Germany, for example, has since issued new restrictions on the use of Actos®.
If you suspect this drug has led to a diagnosis of bladder cancer of someone in your family, contact a litigation attorney quickly by calling the Wyoming office of Burg Simson at 307-527-7891 or fill out our Free Case Evaluation form to discuss your case.
Actos® originally received FDA clearance in 1999. At the FDA’s request, Takeda Pharmaceuticals agreed to undertake a 10-year epidemiological post-market study in 2002, investigating the questions raised about Actos® and bladder cancer.
An interim analysis of the data produced from the study showed an increased likelihood of bladder cancer developing in patients who took Actos® for the longest periods of time and at the highest cumulative doses. The FDA has informed the public that “…use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”
According to the FDA’s warning, “Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk.”
Symptoms of Actos®-related bladder cancer may include:
- Blood in urine, sometimes creating a change in urine color.
- Frequent urination.
- Painful urination.
- Urinary tract infection.
If you or a loved one have exhibited any of these symptoms, call Burg Simpson Wyoming at 307-527-7891 so that you can get the legal assistance your family needs.
Roughly 20 million Americans suffer from Type-2 Diabetes and more than 2.3 million people were prescribed Actos® in 2010.
Actos® belongs to a family of drugs known as Thiazolidinedione, which are drugs used to lower blood sugar levels and increases the body’s sensitivity to insulin. The active ingredient in Actos® (pioglitazone) is also used in combination with other Type-2 diabetes therapies in other medicines such as Actoplus met®, Actoplus met® XR and Duetact®.
Actos® became the world’s most popular Type-2 diabetes medicine in 2007 after medical studies linked Avandia®, a similar drug produced by GlaxoSmithKline, with a 40 percent increased risk of heart attack. According to the National Cancer Institute, there were more than 70,000 cases of bladder cancer in the United States in 2010, resulting in 14,680 deaths.
If you have lost a loved one to bladder cancer, and they had been taking this medication to treat their diabetes, contact Burg Simpson today by calling 307-527-7891.
Call Burg Simpson’s Wyoming Attorneys Today
If you or someone you know has developed bladder cancer after taking Actos®, you may be able to claim compensation for any current and future medical expenses. Fill out our Free Case Evaluation Form HERE or call us at 307-527-7891 to speak with a trial attorney quickly.