Sales of Actos have increased significantly in recent
years, due to potential concerns about side
effects of Avandia. However, recent research suggests that Actos side effects
are also a potential concern for diabetes patients. Concerns about the
potential risk of Actos cancer side effects first surfaced when it was
discovered that rats given the drug had a higher rate of bladder tumors. Recent
results from an on-going 10 year study, involving nearly 200,000 patients with
diabetes, suggests that there may be a risk of Actos bladder cancer the
longer the medication is taken. All of the Actos lawsuits involving cancer include similar
allegations that Takeda failed to adequately research their medication
or warn about the increased risk of Actos causing bladder cancer when it is
used for more than a year.
In June, the FDA mandated that new information
regarding bladder cancer be added to the “Warnings and Precautions” section of
the Actos label, based on the review of the Takeda study that it started in
September 2010. Just days earlier, France, and then Germany, suspended sales of
Actos in those countries, after a separate study commissioned by the French
government found an increased risk of bladder cancer among people who took
Actos the longest, and at the highest cumulative doses. Also 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.
Actos was approved by the FDA to treat Type 2 Diabetes in July,
1999. It is a once-a-day pill that increases the body’s sensitivity to insulin.
After the first reported Actos bladder cancer lawsuit was filed in early August, the number
of complaints filed in various federal district courts has steadily increased,
with more than 25 complaints filed against Takeda Pharmaceuticals so far in
September with many Actos lawyers claiming to have dozens more waiting to file.
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