No European Actos Recall
Charles Pulikowski | January 24th, 2012 | Posted in Actos Bladder Cancer News
Despite affirmative action by France and Germany, the European Medicines Agency (EMA) will not issue a European recall of the controversial diabetes drug Actos. In the United States, Actos bladder cancer lawsuits continue to be filed.
Actos is a drug used to treat diabetes. Many patients who cannot otherwise control their diabetes have been prescribed Actos. However, a June, 2011 FDA drug safety communication warned healthcare practitioners that there may be a connection between Actos bladder cancer. A five-year interim study of a ten-year analysis of Actos use also determined that patients who took Actos for more than one year had an increased risk of developing bladder cancer.
In June, 2011, Frances issued an Actos recall, while Germany suspended sales, but did not recall Actos. And, Actos lawsuits have increased in the United States, which has led to speculation that Actos may be recalled, in Europe or the United States.
However, on October 21, 2011, the EMA announced that it would not recommend recalling Actos.
In August, 2011, the first Actos lawsuit was begun in the United States. Plaintiffs have complained that the manufacturer, Takeda, failed to warn of potential health risks, such as bladder cancer. The FDA study had noted that patients may have a 40 percent increased risk of developing bladder cancer. The U.S. Judicial Panel on Multidistrict Litigation is considering consolidating Actos bladder cancer lawsuits into one court for per-trial proceedings.
Yet, although France and Germany have taken action, the EMA continues to permit Actos sales. The EMA seems to justify their decision on the fact that Actos is a valid diabetes treatment. The EMA does, however, recommend that Actos be taken only when other diabetes medications fail. The EMA also believes that the bladder cancer danger is well known, and patients are therefore aware of the risk. However, the EMA has notified physicians that Actos patients should be monitored for bladder cancer.
The EMA stance was somewhat surprising. Many expected the EMA to issue an Actos recall. Attorneys filing Actos bladder cancer lawsuits may want to keep informed of any further EMA actions.
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