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FDA Delays Actos Combo Drug Review as Actos Bladder Cancer Lawsuits Continue to Mount

12-12-2011 04:50 AM CET | Health & Medicine

Press release from: Nadrich & Cohen LLP

Los Angeles, CA, December 9, 2011 – As Actos bladder cancer lawsuits continue to mount, the Food and Drug Administration has opted to delay its review of a new Type 2 diabetes drug that combines Actos with algoliptin. The FDA’s decision represents another blow to Japanese drug-maker Takeda Pharmaceuticals, who may face as many 10,000 lawsuits from Actos users who claim they developed bladder cancer after taking the drug.

The FDA did not specify why the review, which was originally scheduled for January 25th 2012, was pushed back until April. The federal regulatory agency has been conducting an going safety review of Actos since 2010, when scientific research indicated that use of the drug may potentially lead to an increased risk for developing bladder cancer. In June 2011, the FDA issued new safety warnings advising Actos users that the bladder cancer risk was greatest among those individuals taking the drug for one year or longer.

Actos is currently one of the biggest moneymakers for Takeda Pharmaceuticals, generating nearly $5 billion in revenue in 2010 alone. The drug’s patent is expected to expire next year, leaving other drug manufacturers free to develop generic versions of Actos. The outcome of the pending litigation, however, may have a significant impact on the future sale of the drug.

There are currently an estimated 4,000 lawsuits filed in state and federal courts across the country on behalf of Actos users and their families who claim that the drug caused bladder cancer and other serious side effects. Attorneys for the plaintiffs and Takeda are currently working to have the suits consolidated into a multidistrict litigation in federal court for pretrial purposes.

The FDA says it will continue to monitor the safety of Actos in the U.S. The drug has already been recalled in both France and Germany, despite the European Medical Agency’s stance that Actos is still a suitable treatment for diabetes patients for whom other methods have proven ineffective.

National law firm Nadrich & Cohen is currently investigating Actos users in all 50 states who experienced serious side effects after taking the drug. The firm has created an online resource center at www.SideEffectActos.com to provide the latest news, updates and information to concerned Actos users. Free initial case evaluations are available by calling the Injury Hotline at 1-800-722-0765 or by visiting www.SideEffectActos.com.

If you or a loved one has developed bladder cancer after taking Actos, the law firm of Nadrich & Cohen urges you to contact them today to discuss your claim. All cases are accepted on a contingency basis, meaning there is never a fee unless a judgment is recovered on your behalf.
###

Jennifer Poole

National Client Intake Coordinator

Nadrich & Cohen LLP

12100 Wilshire Blvd. Suite 1250

Los Angeles, CA 90025

800-718-4658

www.personalinjurylawcal.com

Nadrich & Cohen LLP is a national law firm specializing in assisting clients who've been injured by defective medical devices, harmful prescription drugs, car accidents, motorcycle accidents, bicycle accidents and dog bites.

Nadrich & Cohen LLP
12100 Wilshire Blvd
Suite 1250
Los Angeles, CA 90025
800-718-4658
www.personalinjurylawcal.com
Jennifer Poole
National Client Intake Coordinator

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