Friday, October 28, 2011

Bladder Cancer is Acknowledged as Main Actos Side Effect


Actos was first presented as a safer alternative to Avandia as a type 2 diabetes treatment. In recent years though, information has come to light that has thrown that assumption into question. Early data from an on-going 10 year study of Actos side effects conducted by Takeda Pharmaceuticals has suggested that users of the diabetes drug may face an increased risk of cancer when the medication is taken for more than a year. According to a separate five-year data from the study, which involves 193,099 patients with data, patient taking the drug for 12 months or longer had a 40% increased risk of developing Actos bladder cancer. The risk increased with both dose size and duration of treatment.

Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from Avandia, which generated $3.3 billion of sales before the findings. Actos is now the second medication in the thiazolidinedione (TZD) class to be associated with serious side effects within the past year. Last fall, the use of Avandia was severely restricted in the U.S. because of concerns about an increased risk of heart attack. In June 2011, an Actos recall was issued in France after health authorities ordered doctors to stop prescribing the drug due to the possible risk of bladder cancer. A French study of public insurance data confirmed that there is a slight increase in the risk of bladder cancer with Actos use, adding to the prior concerns about long-term use of the medication.
Under the FDA's restrictions last fall, Avanida is to be used only in patients who have failed therapy with Actos. On June 16, 2011, the FDA announced that new warnings about the risk of bladder cancer from Actos will be added to the medication label in the warnings and precautions section. Similar warnings will also be added to other medications that contain pioglitazone, the active ingredient in Actos; including, Actoplus Met, ActoplusMet XR and Duetact. Because of these new findings, dozens of of individuals suffering with bladder cancer after taking the drug have filed an Actos lawsuit seeking compensation for their injury. In fact, a class action lawsuit has recently been filed in Louisiana against Takeda pharmaceuticals claiming that information about the danger of Actos bladder cancer was suppressed or hidden from the general public. 

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