FDA Delays Actos Combination Drug Review
The U.S. Food and Drug Administration has announced it will delay its review of algoliptin, a new Type 2 diabetes medication, and a fixed-dose combination form of the drug that includes Actos.
Takeda Pharmaceuticals, the maker of Actos, recently announced that the FDA had pushed back its review of the new diabetes medications until April 2012. The review was scheduled to take place in January 2012. No reason has yet been given as to why the FDA chose to delay the review.
The FDA’s decision may signal more bad news for the Japanese drug-maker. The company is currently facing numerous lawsuits which allege that Actos caused bladder cancer and other serious side effects in patients who used the drug. A hearing is scheduled in December at which time the U.S. Panel on Multidistrict Litigation will decide whether to consolidate the Actos lawsuits for pretrial proceedings.
The lawsuits stem from an FDA warning issued earlier this year, which advised patients and physicians that long-term use of Actos could potentially lead to an increased risk of developing bladder cancer. The drug has already been pulled off the market in both France and Germany but the FDA has yet to make a decision regarding the future sale of Actos in the U.S.
Algoliptin was approved for medical use in Japan in 2010. The combination drug which includes algoliptin and Actos is was approved for sale in Japan in July 2011. In August 2012, Actos is expected to lose its patent protection, meaning other pharmaceutical companies will be able to manufacture generic versions. However, the outcome of the pending Actos litigation may potentially affect the continued sale of the drug. In 2010, sales of Actos generated nearly $4 billion in revenue for Takeda Pharmaceuticals.
Actos was first approved for the treatment of Type 2 diabetes by the FDA in 1999. In September 2010, the FDA announced that it would be conducting an ongoing safety review of the drug. In June of this year, the results of a ten-year research study linked Actos to bladder cancer, leading to the most recent safety warnings.
If you or someone you love has developed bladder cancer after using Actos, you need to speak to an experienced personal injury attorney. Each state has different limitations on how long Actos users may have to file an injury claim and an Actos attorney can advise you of your rights.
The law firm of Nadrich & Cohen, LLP is currently investigating claims from Actos users in all 50 states. We specialize in assisting Actos users who’ve experienced serious adverse health effects get the compensation they’re entitled to for their injuries.
Call our Injury Hotline today at 1-800-722-0765 to speak with a member of our Actos legal team. You may also visit www.SideEffectActos.com for the latest news, updates and information on the Actos litigation. Don’t hesitate to contact our Actos injury experts today to discuss your case. Your initial case evaluation is absolutely free and there is never a fee unless we recover a judgment on your behalf.