Actos Linked to Bladder Cancer

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FDA Warns of Bladder Cancer Risk With Actos

Actos News

Patients taking the diabetes drug Actos for more than a year may have an increased risk of bladder cancer, according to an FDA interim review of an ongoing epidemiological study..
The warning comes just days after two European countries banned use of the drug. The European Medicines Agency (EMA) has yet to release any guidance on use of Actos.
The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
Officials say information about this risk will be added to the label of the drug as well as the patient medication guide. FDA officials say in light of this new information, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.

New Warning for Actos

In September, the FDA launched a safety review of Actos after initial data from the manufacturers ongoing 10-year study suggested that the drug may increase the risk of bladder cancer. The agency says it is also aware of a recent epidemiological study in France that also suggests an increased risk of bladder cancer associated with Actos. Based on this study, France has suspended use of the drug and advised not starting Actos in new patients. Actos is part of a class of drugs known as thiazolidinediones that is used to treat type 2 diabetes. It is designed to help control blood sugar levels by increasing the bodys sensitivity to insulin.
The FDA says people currently taking Actos should continue taking it until advised otherwise by their health professional. Those who are concerned about the possible risk of bladder cancer should talk to their health care provider.

FDA Alert

Possible signs/symptoms of bladder cancer from Actos may include:
Actos Side Effect: Blood in the Urine
Actos Side Effect: Pain During Urination
Actos Side Effect: Frequent Urination
Actos Side Effect: Feeling of Need to Urinate Without Results

What is Actos (Pioglitazone)?

Actos (Pioglitazone) is a prescription drug of the class thiazolidinedione (TZD) with hypoglycemic (antihyperglycemic, antidiabetic) action. Pioglitazone is marketed as trademarks Actos in the USA, the UK and Germany, Glustin in Europe,"Glizone" and "Pioz" in India by Zydus CND and USV respectively and Zactos in Mexico by Takeda Pharmaceuticals. Actos was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion.[1] Its cardiovascular safety profile compares favorably with rosiglitazone (Avandia), which was withdrawn after concerns about an increased risk of cardiac events, but pioglitazone has subsequently been found to be associated with bladder tumors and has been withdrawn in some countries.

FDA SAFETY WATCH ON Actos
Actos (Pioglitazone): Bladder Cancer Risk
[Posted 08/04/2011]
 
See Drug Safety Communication for additional information, including a data summary and recommendations for healthcare professionals and patients.
http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm