Actos – Background & FDA Warnings
Actos is the brand name for the drug pioglitazone. It was first approved by the U.S. Food and Drug Administration (FDA) in 1999 for the treatment of Type II diabetes, the most common form of diabetes in North America, and quickly became one of the best-selling medications in the United States. In 2010 alone, it brought in an estimated $4 billion in revenue for its manufacturer, Takeda Pharmaceuticals.
Unfortunately, growing evidence indicates that patients taking Actos could face serious side effects, including a 22 percent risk of developing bladder cancer. In July 2011, the U.S. Food and Drug Administration (FDA) warned the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer.
Plaintiffs nationwide are bringing Actos lawsuits for complications resulting from use of the drug.
If you or someone you know has used Actos and suffered harmful side effects, contact The Driscoll Firm, LLC, at 314-932-3232 to speak to an experienced injury attorney about your case. You might have a legal right to compensation.
FDA Warnings of Actos Risks
Pioglitazone is sold as a single-ingredient product under the Actos brand name. It is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). The FDA has recommended that it be used along with diet and exercise to improve control of blood sugar in adults with Type II diabetes. From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.
The first research data linking Actos with bladder cancer came in animal studies. Subsequently, a PROactive clinical trial showed that human patients taking Actos developed bladder cancer at a rate 2.5 times greater than patients taking a placebo. The FDA review in 2011 reported that its Adverse Event Reporting System (AERS) demonstrated “a definite signal for bladder cancer associated with [Actos] use” after 6 to 24 months of patient exposure.
France has suspended the use of Actos, and Germany has recommended that Actos not be prescribed to new patients. Researchers in France followed approximately 1.5 million adults with diabetes for up to four years. The results showed a “statistically significant increase in the risk of bladder cancer in patients exposed to [Actos] compared to patients exposed to other anti-diabetic agents,” according to the FDA.
The FDA has advised healthcare officials to counsel patients to report any signs or symptoms of blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.
Contact an Actos Litigation Lawyer Today
It is important to act promptly if you believe you have a legal claim as a result of Actos use. Call 314-932-3232 today to speak with an experienced injury lawyer at The Driscoll Firm, LLC, about the facts of your case and the possibility of financial compensation.
The Driscoll Firm, LLC, has represented clients injured by dangerous pharmaceuticals and medical devices for more than a decade. John J. Driscoll solely represents plaintiffs and focuses his practice on complex product liability actions, consumer class actions and personal-injury litigation. He is a member of the prestigious Million Dollar Advocates Forum and the Multi-Million Dollar Advocates Forum.
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