Earlier this year, the first of 3000 injury cases against Japanese pharmaceutical company Takeda was heard in a Los Angeles court. The allegation: their flagship product, Actos, had caused plaintiff Jack Cooper to develop bladder cancer. Although Mr.
Actos Bladder Cancer
Recent activity by the United States Food & Drug Administration (FDA), as well as its European counter-part, the European Medicines Agency (EMA), has both doctors and users of the Type 2 Diabetes drug Actos (Pioglitazone) severely concerned.
As of June 10, 2011 the drug Actos has been removed from shelves in France and German doctors have been instructed not to prescribe Actos to their patients. These efforts come in response to recent studies that show an increased rate in bladder cancer amongst users who have undergone treatment for their Type 2 Diabetes using Actos.
Although the occurrence of such cancers in animal test subjects during pre-market studies was well know to regulatory agencies and the manufacturer, Takeda, Inc., the drug Actos, as well various combination therapy regiments that incorporate Actos, have been used to treat Type 2 Diabetes since 2000. More than 2.3 million prescriptions for the drug were issued in the United States in 2010, and Actos been considered one of the top selling drugs in the American marketplace. The active ingredient in Actos, Pioglitazone, is also used in ActoPlus met, ActoPlus met XR and Duetac to treat Type 2 Diabetes.
On June 15, 2011, in a move less drastic then that of the European regulatory agencies, the FDA issued an urgent health warning to users and prescribers of the drug Actos acknowledging the recent statistical data that shows up to a 40% increase in risk for bladder cancer in users of Actos. The studies further show that the risk of bladder cancer increases with higher dosages and longer courses of treatment with Actos.
The FDA will now require that these recent findings and risks be included in warnings attached to the drug packaging and future marketing materials. Invoking a wait and see approach, the FDA has insisted that it will continue to monitor the data being released by various ongoing studies into the long term health effects of Actos (Pioglitazone). In the meantime, Actos remains available to consumers in the United States despite these newfound risks.
- Questions and answers on the review of pioglitazone-containing medicines (Actos, Glustin, Competact, Glubrava and Tandemact)
- European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer
- Takeda Pharmaceutical Company Limited Financial Highlights
- Actos FDA Approval Letter 1999
In The News
Late last month, a Los Angeles jury decided that Takeda executives were in fact aware of the cancer risk from its flagship product, Actos – and ordered the Japanese pharmaceutical giant to pay $6.5 million to plaintiff Jack Cooper and his wife. Cooper's lawyers presented the court with evidence demonstrating that Takeda executives were aware of the risks associated with Actos as far back as 2004 – yet spent the next seven years hiding this information from regulators.
Jack Cooper, a retired communications worker, states that at age sixty-four – prior to being prescribed the diabetic drug Actos – he was in good health and looking forward to many more years with his wife of nearly fifty years and his grandchildren.
Just two years ago, Takeda Pharmaceuticals' Actos (dabigatran) was the top-selling diabetic drug in the world. With over $4.5 billion in sales, it accounted for 27% of the company's revenue.
Today, the drug has been been implicated in the development of bladder cancer. It has been pulled from pharmacy shelves in the E.U. and is under increasing scrutiny by the U.S. Food and Drug Administration (FDA). The British Medical Journal (BMJ) recently published a study which demonstrated an increasing risk of developing bladder cancer with long-term use.
Several law firms across the country have issued press releases across the Internet with the news many bladder cancer victims have been waiting for. The first trial involving Takeda Pharmaceuticals and their allegedly-defective diabetic drug, Actos, will commence on 19 February, 2013.
The case involves one Jack Cooper and other parties, and will be overseen by the Honorable Judge Kenneth R. Freeman.
An example arose in West Virginia recently illustrating how a party other than a drug manufacturer can bear potential liability – in this case, the pharmacy that sold the prescription.
If you have been prescribed a dangerous drug or received a defective medical device – such as a hip or joint implant or a pelvic mesh, both of which have been demonstrated to cause serious health problems – you understand that you have a right to sue the manufacturer for damages.
Awhile back, we brought you an article about Takeda Pharmaceuticals, maker of the diabetic prescription drug Actos, discussing allegations of whether or not the company knew of the dangers of their flagship product. Central to the story is one Dr. Helen Ge, who worked for Takeda as a product reviewer. According to Dr.
IN August, when Takeda's patent on the diabetic drug Actos expired, the Food and Drug Administration (FDA) granted three pharmaceutical firms – Mylan, Ranbaxy and Teva – authorization to market their own generic version of the medication. One company's application was denied, however. That company – Watson Pharmaceutical – filed a lawsuit against the FDA in response.