actos France's move came in the wake of an official study, which found that Actos and its sister drug Competact appeared to slightly boost the risk of bladder cancer. After reviewing the French study, Reuters reports, Germany's Federal Institute for Drugs and Medical Devices announced that while patients currently using the drug should continue until they see their doctors, no new scrips should be written.Sign up for our FREE newsletter for more news like this sent to your inbox! The European Medicines Agency started its review of Actos safety in March.
after FDA launched its own analysis last fall. European experts are slated to discuss the latest data at a meeting beginning June 20, the news service reports. Meanwhile, Japanese authorities say they have no plans to recall Actos, which accounted for 27 percent of Takeda's revenues, with global sales of $4.8 billion.The decision was based on a study by a national French insurer and examined nearly 1.5 million people between 40 and 79 years old who were treated between 2006 and 2009 (read the statement). The move by the AFSSAPS will by the European Medicines Agency. Actos was approved in Europe in 2000 as an option for patients who do not benefit from metformin, a standard treatment, or metformin and insulin. of bladder cancer is real and balancing this potential risk of bladder cancer with Actos’s known benefits,” a source familiar with the med and regulatory procedure tells us. “We have no convincing evidence from randomized clinical trials that pioglitazone reduces the macrovascular risks associated with type-2 diabetes.”
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