The FDA issued warnings in 2011 about an association between the diabetes drug Actos and bladder cancer. In September 2010, the FDA first notified the public of Actos' link to bladder cancer but did not recommend stopping its prescription. It was not until June 2011 that the FDA issued an updated warning, recommending caution in prescribing Actos to patients with a history of bladder cancer. In August 2011, the FDA finally added a safety warning about the potential increased risk of bladder cancer from long-term Actos use to the drug's label.

1. S A D A K A R E P O R T : I S S U E B R I E F
Actos & Call Us
Bladder Cancer 1-800-810-3457
The Food and Drug Administration (FDA) issued Actos Bladder Cancer Timeline
a warning on June 2011 that Actos (pioglitazone) September 2010 FDA Notifies Public
is associated with an increased risk of bladder June 2011 ! FDA Issues Updated Warning
cancer.
August 2011 Warning added to label
The FDA first notified the public about Actos’ link to
bladder cancer in September 2010. At that time, the
FDA did not recommend that healthcare providers Why Sadaka Associates?
discontinue prescribing Actos. It was not until close
1. Experience. Sadaka Associates has
to a year later that a change to the warning label was
represented both American and foreign companies
made.
in business disputes as well as thousands of
June 15, 2011 Updated Warning individuals harmed by pharmaceuticals, medical
devices and vaccines.
On June 15, 2011 the FDA issued an update on it’s
investigation of the association between Actos and 2. Expertise. Mr. Sadaka’s educational
bladder cancer. This time the FDA recommended that background and legal expertise in complex
healthcare professionals should not use Actos in litigation has made him a nationally recognized
patients with active bladder cancer, and use the drug trial lawyer and trusted counsel for nearly a
with caution in patients with a prior history of decade.
bladder cancer..
3. Execution. Mr. Sadaka brings a combination
FDA Finally Adds Actos Bladder Cancer To Label of expertise in both science and law that makes
him a highly valued, trusted counsel to his clients.
In August 2011 FDA updated the labeling of this
medication, to include safety information that the use
of Actos for more than one year may be associated
with an increased risk of bladder cancer.
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