Posted In: Drug Litigation

What is Actos?

Actos is an oral diabetes medicine that helps control blood sugar levels.

Actos is for people with type 2 (non-insulin-dependent) diabetes. Pioglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

The Adverse Effects of Actos

The FDA has issued a warning that Actos may be linked to an increased risk of bladder cancer, especially in patients who use the medication for more than one year. Information about the risk of bladder cancer will be added to the Actos warning label. Preliminary results from a long-term observational study found an increased risk of bladder cancer in patients with the longest exposure to Actos and the highest cumulative dose of the drug. Patients who have bladder cancer are urged not to use Actos, while the medication should be used with caution in patients who have a prior history of bladder cancer, the FDA warns.

Meanwhile, both Germany and France have suspended sales of Actos. The Actos suspension is effective July 11, 2011. Actos (pioglitazone), along with another diabetes drug made by Takeda Pharmaceutical, Competact, came under fire in Europe after a study revealed an increased risk for bladder cancer among diabetes patients who were taking the medication. The announcement of the suspension for Actos bladder cancer concerns may affect an estimated 230,000 individuals who currently use Actos or Competact in France alone, and those who have been prescribed Actos or Competact will now need to switch to another diabetes medication.

Possible signs or symptoms of bladder cancer from Actos may include:

  • Blood in the urine
  • Pain during urination
  • Frequent urination
  • Feeling of need to urinate without results

The FDA’s decision to request the addition of an Actos Black Box Warning was announced during a June 2007 US House of Representatives hearing. This hearing was convened in light of concerns that the FDA knew about Actos and Avandia cardiovascular risks, but failed to respond adequately. Several lawmakers and health experts have criticized the FDA for failing to warn the public about known cardiovascular risks associated with Actos and Avandia.

The FDA seems to have had ample evidence about the risks associated with Actos and Avandia. In 2006, FDA drug safety advisor Dr. Rosemary Johann-Liang urged the agency to add a black box warning to Actos and Avandia because of serious cardiovascular risks. Instead of heeding her warning, however, the agency reprimanded Johann-Liang and did nothing to adequately inform consumers about the possible risks associated with Actos and Avandia.

As early as 1999, when Avandia first hit the market, Dr. John Buse, prominent endocrinologist and incoming president of the American Diabetes Association, warned about the cardiovascular risks associated with this class of drugs. Dr. Buse’s concerns were met with threats by the makers of Avandia, who accused Buse of hurting their market prospects. No action was taken to investigate these serious concerns over Actos cardiovascular side effects.

Representative Henry Waxman has accused the FDA of “dropping the ball” with regards to overseeing the safety of Avandia and related drugs like Actos. He has also declared that the FDA’s shortcomings over Avandia and Actos represent a “failure of the current system” to adequately determine and communicate the serious risks associated with widely used prescription medications.

If you or a loved one has suffered from bladder cancer while taking Actos, you may wish to contact a qualified and experienced Actos bladder cancer attorney who can evaluate your case to determine your legal rights and options to file an Actos lawsuit.

Do I have an Actos Lawsuit?

Slater Slater Schulman LLP is dedicated to the representation of plaintiffs in Actos bladder cancer lawsuits. Our firm is handling litigation related to these injuries nationwide.

If you or someone you love has taken Actos, you should contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling us at (800) 251-6990.

Medical disclaimer: Please note that any change in medications should be made only after consulting with your doctor about the risks and benefits of doing so, and should not be based on any information contained in this web site.

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