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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