Actos, or pioglitazone, belongs to a class of medications called thiazolidinediones (TZDs). This oral medication, in addition to ACTOplus met, ACTOplus met XR, and duetact, is taken in tablet form and is prescribed to treat Type 2 diabetic patients who are not dependent on insulin. Used in conjunction with diet and exercise, Actos is intended to aid in two ways: to help the body use naturally produced insulin more effectively and to stop the liver from overproducing sugar.
Manufactured by Takeda Pharmaceuticals North America, Actos was approved for use in July 1999. Food and Drug Administration (FDA) records show that approximately 2.3 million prescriptions for Actos were filled from January-October 2010 alone, generating more than four billion dollars in sales. While some Actos consumers have found significant help in treating Type 2 diabetes, others have suffered life-threatening conditions due to Takeda’s unwillingness to update doctors and patients on serious sides effects from long term use. According to a lawsuit filed in 2010, Takeda Pharmaceuticals under-reported adverse events to the FDA. The FDA relies on factual reporting to evaluate the safety and effectiveness of drugs, and, by misleading the FDA, Takeda put users at greater risk.
Metformin, one ingredient in ACTOplus, can cause lactic acidosis, the buildup of acid in the blood. This condition must be treated in a hospital or can lead to death, especially in people with kidney problems.
On January 31, 2010, the FDA listed Actos, in addition to various other drugs, on its watch list. According to its Adverse Event Reporting System (AERS) with a reporting date of July-September 2010, the FDA identified a “potential safety risk” between Actos users and rhabdomyolysis. When muscles endure damage, through such events as muscle trauma or overuse, alcohol abuse, or drug use, they release a protein called myoglobin, an iron- and oxygen-binder found in the muscles of all vertebrates, into the bloodstream. The kidneys then try and remove the myoglobin from the body through urine, but too much of this protein can cause severe kidney damage. Because the course and location of rhabdomyolsis varies from patient to patient, symptoms are often difficult to pinpoint, but if you are using or have used Actos and experience abnormal urine color (dark, red, or cola-colored), decreased urine productions, muscle tenderness, weakness, or stiffness, or joint pain, contact your doctor immediately before severe damage occurs. Urine tests can be performed in order to detect rhabdomyolsis.
Women using Actos are more susceptible to bone fractures, especially in the hands, upper arms, and feet.
Congestive Heart Failure
Taking Actos can lead to endema, the retention of excessive fluid in cells and tissues, and the creation of new fat cells. Water retention and weight gain may lead to congestive heart failure because of the added pressure placed on the heart and respiratory system, thus increasing the risk of heart attack and ultimately death. Helen Ge, former Takeda medical reviewer, filed a lawsuit against her employer claiming Takeda “failed to report a series of congestive heart failure cases to the U.S. Food and Drug Administration” in order to hide evidence and increase sales.
After an initial study revealed a link between Actos and bladder tumors in rats, the FDA required a more comprehensive, ten-year study to be completed. According to Kristina Flore, staff writer for MedPage Today and ABCNews, at the conclusion of this study, patients on Actos “for more than a year had a 40% increased risk of bladder cancer compared to those who never took it.” In June 2011, both France and Germany suspended the prescription of Actos by doctors to new patients. The British Medical Journal (BMJ), in an article dated May 31, 2012, published research which shows risk of bladder cancer in patients taking Actos actually doubles.
Have You Been Affected by Actos?
Any individual or the relative of an individual who has suffered due to Actos’ side effects is permitted to file a lawsuit. The professional lawyers help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).
Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case. If you need further information about the harmful side effects of Actos or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.