FDA Drug Safety Communication: Risk of Bladder Cancer in Patients taking Actos (Pioglitazone):

Actos FDA Warnings

On June 15, 2011, the Food and Drug Administration released a safety communication to inform the public of a possible increased risk of bladder cancer in patients taking Actos for longer than one year. The FDA based this communication on its safety review of data from an ongoing ten-year study of the long-term risk of bladder cancer associated with taking Actos.


The ten-year study is looking at the incidence of bladder cancer associated with taking Actos among a group of over 193,000 patients enrolled in the Kaiser Permanente Northern California (KPNC) health plan. A five-year interim analysis reviewed by the FDA showed no overall increase in bladder cancer in patients taking Actos compared to patients never having taken Actos. Significantly increased risk of bladder cancer was seen, however, with the highest Actos doses and with taking Actos over extended periods of time. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

The FDA is also conducting a comprehensive review of a study by the French National Health Insurance Plan. This study followed approximately 1.5 million patients with diabetes for a period of four years. The results indicated a significantly higher risk of bladder cancer in male patients taking Actos compared to patients taking other diabetes drugs, with the greatest risk occurring with higher Actos dosage and duration of treatment.

While the FDA will continue to review the available data and update the public accordingly, the FDA has not yet concluded that Actos increases the risk of bladder cancer. It has stated in the interim that healthcare professionals should continue to follow the recommendations in the drug labeling when prescribing Actos, and that patients should continue taking Actos as prescribed unless told otherwise by their healthcare professional. Patients concerned about their risks from taking Actos are encouraged to speak with their healthcare professional.

In the meantime, the FDA has approved updated drug labels for drugs containing Actos as a warning to healthcare professionals and patients of a possible increased risk of bladder cancer when taking Actos for longer than one year. Drugs containing Actos include Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended-release), and Duetact (pioglitazone/glimepiride). The updated labels recommend that healthcare professionals should not prescribe Actos drugs to patients having bladder cancer and to use caution in patients with a prior history of bladder cancer. Patients are encouraged to contact their healthcare professional if they see any signs of blood in their urine, new or worsening pain on urination, urination urgency, or pain in the back or lower abdomen since taking an Actos drug, as these symptoms may be signs of bladder cancer.


To tell us about your case, please fill out the 'Free Consultation' form in the right pane.


● Helpful Articles

Free Consultation  Call Now
Receive an Immediate Response
ANDREW SULLO IS A TOP 100 NATIONAL TRIAL LAWYER | 2013 • 2014 • 2015 • 2016 • 2017
Obtener una Respuesta Inmediata
Andrew Sullo – 100 Mejores Abogados Nacional | 2013 • 2014 • 2015 • 2016 • 2017

Justice

Andrew Sullo is a Member of the

AMERICAN ASSOCIATION
FOR JUSTICE

2013 2014 2015 2016 2017
MORE THAN 1000 CASES TRIED & MORE NOT GUILTY JURY VERDICTS
at Houston Municipal Court than any other Law Firm in 2009, 2010, 2011, 2012, 2013, 2014...

Trial Lawyers

Andrew Sullo has been named a
TOP 100 NATIONAL TRIAL LAWYER
by the National Trial Lawyers in
2013 2014 2015 2016 2017

CALL NOW FOR A FREE LEGAL CONSULTATION (800) 730-7607 CALL NOW FOR A FREE LEGAL CONSULTATION (713) 839-9026
IF YOU OR A LOVED ONE WERE SERIOUSLY INJURED DUE TO THE NEGLIGENCE OF ANOTHER, CONTACT SULLO & SULLO IMMEDIATELY.
CALL NOW
(800) 730-7607
CALL NOW
(713) 839-9026

GET LEGAL HELP

image
Live CHAT

Chat Online with a Knowledgeable Representative About Your Case.