A large new study has contradicted earlier ones that linked the diabetes drugs Actos and Avandia to bladder cancer, according to Science Daily.
The most recent study, published in December 2014 in Diabetologia (the journal of the European Association for the Study of Diabetes), found no link between pioglitazone (Actos) or rosiglitazone (Avandia) and bladder cancer.
More than one million people in six worldwide populations were part of this large-scale study.
Actos and Avandia — top-selling medications used to treat Type 2 diabetes by decreasing blood-sugar levels — have been shrouded in questions about their safety. Some preclinical studies found that male rats over exposed to pioglitazone were at an increased risk of bladder cancer. In recent years, hundreds of Actos bladder cancer awsuits have been filed by users who claimed the drug caused their cancer.
The studies’ outcomes and reports of bladder cancer in Actos users led to the withdrawal of pioglitazone in France and Germany. The U.S. Food and Drug Administration as well as the European Medicines Agency (EMA) have advised that patients with current or previous bladder cancer should not take pioglitazone.
In 2011, the FDA issued a safety statement that a label change had been ordered informing the public that using pioglitazone-containing medicines for more than one year may be associated with an increased risk of bladder cancer. The updated drug labels also warned that patients with active bladder cancer or a prior history of bladder cancer not use the drug or use it with caution.
This new study, aimed at investigating a possible research bias and limitations with earlier studies, measured the effect of exposure to pioglitazone on bladder cancer risk across the world. Researchers gathered prescription, cancer and mortality data from people with type 2 diabetes from six countries: British Columbia (Canada); Finland, Manchester (UK), Rotterdam (Netherlands), Scotland, and the UK Clinical Practice Research Datalink (covering 566 general practices in the UK).
The data of 1.01 million people was pooled. Results showed 3,248 cases of bladder cancer, with only 117 cases in those patients ever exposed to pioglitazone. Researchers found no link between exposure to pioglitazone or rosiglitazone and bladder cancer in men or women. This contradicts the findings of previous studies, and evidence used in trial for Actos bladder cancer lawsuit plaintiffs.
In April 2014, Bloomberg reported that Actos manufacturer Takeda Pharmaceutical Co. and Eli Lilly & Co. were ordered to pay a combined $9 billion in punitive damages after a federal court jury found they hid the cancer risks of Actos in the first U.S. trial of its kind.
Numerous other Actos class action and individual lawsuits are being filed nationwide.
Bladder cancer is the ninth most common cancer in the world, with 430,000 new cases diagnosed in 2012. Europe and North America have the highest incidence of bladder cancer. People with diabetes are at an increased risk of the bladder cancer.
The bladder is a balloon-shaped organ in the pelvic region that stores urine. Bladder cancer begins most often in the cells that line the inside of the bladder. Older adults are most likely to get bladder cancer, though it can strike at any age.
“The great majority of bladder cancers are diagnosed at an early stage — when bladder cancer is highly treatable,” according to the Mayo Clinic.
“However, even early-stage bladder cancer is likely to recur. For this reason, bladder cancer survivors often undergo follow-up tests to look for bladder cancer recurrence for years after treatment.”
Bladder cancer symptoms include blood in the urine, (urine may appear dark yellow, bright red or dark brown); frequent urination, painful urination, back pain or pelvic pain.
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