By William Bill Hurst
Takeda Pharmaceutical Company is Asia’s biggest drug maker and they face tens of thousands of lawsuits in the United States courts over allegations that the Actos diabetes drug causes bladder cancer. This drug was marketed for Takeda in the United States by the Indianapolis based Eli Lilly & Company from July, 1999 until March, 2006 and in several other companies up until this year. This drug, coupled with diet and exercise, was used as therapy to improve glycemic control for Type II diabetics.
U.S. regulators found in June that an analysis of a company sponsored study showed that some users of Actos faced an increased risk for developing the potentially fatal disease. There has been other evidence linking Actos to an increased risk of other serious side effects such as blindness and macular edema. Personal Injury Attorneys across the nation are indicating that they are getting calls every day and believe that it may result in as many as 10,000 lawsuits.
Takeda officials this year recalled Actos, its top-selling drug, off the market in Germany and France because of the linkage to increased cancer risk. The medication had sales of 4.8 billion in the last fiscal year and was 27% of the Japan based company’s revenue.
Pioglitazone hydrochloride, (Actos) was developed by Takeda and was distributed in markets since 1999. Actos oral tablets were marketed as a medication which would help the body use insulin more efficiently. There were a lot of warnings and contraindications that accompanied the drug and users were cautioned to have regular blood tests to monitor potential damage to their liver. However, this list did not include the increased risk of cancer. According to a December 1, 2011 article by the Associated Press in the Indianapolis Star, Eli Lilly, one of the distributors, lobbying costs in the third quarter of 2010 approached 2.3 million focusing on patent reform, trade issues and hospital discounts. Actos sales in this article in 2010 were shown to be approximately 3.35 billion dollars with the drug going generic in 2012. It is noted that not withstanding Takeda’s patent for Actos actually expiring last January, 2011, Takeda, and possibly Lilly and Glaxos Smith Klein, may be battling the forthcoming tide of Actos lawsuits. Despite that Takeda has already agreed to several generic drug makers on the future marketing of a generic form of Actos.
Both Germany and France have suspended sales of Actos. The suspension was effective July 11, 2011. The Food and Drug Administration recently released a safety alert and required a label change for Actos regarding the risk of bladder cancer for users taking the medication for more than one year or taking it in the highest dose. According to the FDA announcement, Actos can lead to a 40% increased risk of bladder cancer based on a study of more than 200,000 patients with Type II diabetes. Since 2007 the competing diabetes drug Avandia was shown to increase the risk of heart attack the Actos sales have escalated to approximately 4.3 billion in 2010 alone.
The France Medicine Agency has suspended the sales of Actos after reviewing a cohort study conducted by the French Health Insurance linking Actos to bladder cancer. Drug regulators in Germany have also disallowed new prescriptions for Actos pending further investigation. The European Medicine Agency began a review of Actos in March, 2011 which has not yet concluded but may ultimately yield similar findings. Between January and October of 2010, 2.3 million patients filled prescriptions for Actos according to the FDA. Based on the 40% increase of risk the number of people who may develop bladder cancer since the drug’s approval in 1999 could easily number in the thousands.
On December 29, 2011, the U.S. Judicial Panel on Multidistrict Litigation ordered that all Actos lawsuits pending in Federal Courts nationwide be consolidated and centralized in the nearest District Court for the Western District of Louisiana and assigned to the Honorable Rebecca Dougherty. This is a consolidation of all Actos lawsuits filed by individuals alleging that the Type II diabetes medication caused them to develop bladder cancer. When reaching the decision to consolidate the Actos lawsuits the Panel determined that there were common questions of fact to warrant the transfer of these actions into one Federal District Court for coordination, consolidation and pretrial proceedings thereby eliminating duplicative discovery and consistent pretrial rulings and conserve the resources of the parties, their counsel and the judiciary. At that time there were only a few, perhaps less than 20, Actos lawsuits currently pending in Federal Courts nationwide. All of these lawsuits were filed after the June, 2011 determination by the U.S. Food and Drug Administration that Actos users are at increased risk for developing bladder cancer.
See the side effects of Actos here.
For several previously known side effects of Actos, including problems such as headaches, sinus infection, and upper respiratory infections. More serious side effects would include low blood sugar, rapid weight gain, vision changes, pain, tooth problems, sore throat, water gain, edema. Actos was also promoted as increasing the good cholesterol and decreasing triglycerides. www.Actos.com