Despite a reported link to an increased risk of bladder cancer, European drug regulators have determined that a recall of the diabetes drug Actos is not necessary. On October 21, 2011 the European Medicines Agency issued a clarification of its position on Actos, also marketed as Glustin in Europe. The EMA is now urging doctors to only recommend the drug to patients if other medications for diabetes have proven effective.
Due to the risk of bladder cancer, patients should be started on a lower dosage of the medication. The EMA statement is a clarification of a previous statement made in July, 2011. The EMA’s Committee for Medicinal Products for Human Use confirmed an increased risk of bladder cancer as an additional side effect of Actos.
CHMP confirmed that the risk of bladder cancer does exist, and recommends regular monitoring by the patient’s doctor including blood tests and careful monitoring for signs of bladder cancer. CHMP must still adopt the opinion, including the clarification, as an official decision. Some European countries have not readily accepted the findings. France recalled the diabetes drug in June, 2011 due to the bladder cancer risk.
Actos (officially known as pioglitazone) was first introduced as a treatment for type 2 diabetes in 1999. By 2008, it was the tenth-best selling drug in the United States with annual sales of nearly $2.5 billion. Worldwide sales were at nearly $4 billion in 2010. Prior to recalls and warnings of side effects, Actos was Takeda Pharmaceuticals’ best-selling drug. The medication is not considered effective for treatment for type 1 diabetes. Additional side effects of Actos may include mild weight gain, anemia, headaches, dental problems, fluid retention and upper respiratory tract infections.
U.S. Food and Drug Administration officials launched an investigation into the increased risk of bladder cancer in September of 2010. Initial data suggesting the bladder cancer link came from a decade-long study on users of the drug. New Actos warnings were approved in the U.S. in August, 2011 noting that patients taking the medication for more than one year may face an increased risk of developing bladder cancer. The warning includes recommendations for regular monitoring. Several users are already pursuing lawsuits against Takeda regarding the new warning. The lawsuits contend that Takeda failed to provide proper warnings after they first became aware of the risk.
The majority of complaints in the lawsuits claim that Takeda should have voluntarily removed the medication from the market once they became aware of the link to an increased risk of bladder cancer. A group of judges is scheduled to meet December 1, 2011 to determine if all cases pending in federal courts throughout the U.S. should be consolidated into a single class action lawsuit. The patient Medication Guide for Actos will be updated to include the bladder cancer warning.
If you or a loved one has suffered from severe side effects, including symptoms of bladder cancer, as a result of using Actos, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication use. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.