Takeda Pharmaceuticals makes the diabetes medicine Actos® (pioglitazone). The prescription medication helps persons with type 2 diabetes, when combined with exercise and a proper diet, to control their blood sugar levels. It is not for patients with type 1 (juvenile) diabetes or those with diabetic ketoacidosis.
It is sold as Actos®, ACTOplus met, ACTOplus met XR, and duetact.
FDA Warns Patients and Doctors About Bladder Cancer Risk
Takeda is conducting a ten-year study of the safety of Actos®. The U.S. Food and Drug Administration (FDA) has looked at interim five-year results of the study and concluded that patients taking Actos® for more than a year at higher cumulative doses have an increased risk of bladder cancer.
On June 15, 2011, the FDA issued an announcement about the risk of bladder cancer in patients taking Actos® for over a year and also required Takeda to put information about this risk on the drug label. In addition, the drug company was required to update the drug's medication guide with the new safety information.
France and Germany Ban the Drug
While the FDA warned health care providers and patients in the U.S. about the increased risk of bladder cancer, both France and Germany banned the sale of the drug. The actions in those two countries were based on a French safety study of the medication. The French study included about 1.5 million patients who took Actos® for up to four years.
Other Problems with Actos®
Actos® has been linked to other problems, including congestive heart failure. Takeda includes a boxed warning in the medication guide of the Actos® group of medications saying:
- The medications can cause or worsen heart failure. (Heart failure occurs when the heart is unable to pump blood efficiently around the body.)
- Certain patients with symptoms of heart failure should not take Actos®. Symptoms include rapid weight gain, swelling due to fluid retention, shortness of breath, unusual fatigue.
- Patients with severe heart failure should not take any of the Actos® medications.
Another potential problem specific to ACTOplus and ACTOSplus met XR is an increased risk of lactic acidosis, which occurs when an acid builds up in the blood and can cause death. Lactic acidosis is a medical emergency that must be treated immediately in the hospital. The condition occurs most often in patients with kidney problems, and therefore these two drugs should not be given to patients with kidney disease or persons older than 80 years with compromised kidneys. The drugs also should not be given to patients with metabolic acidosis or those who drink large amounts of alcohol.
Actos® and its other forms may cause liver problems. Patients should speak to their doctors immediately if they have symptoms of liver disease, including nausea, vomiting, stomach pain, unusual fatigue, loss of appetite, dark urine, or yellowing of the skin or whites of the eyes.
Women taking Actos® might also have a higher risk of breaking bones. All patients have a greater risk of hypoglycemia (low blood sugar) if they are taking additional anti-diabetic medications.
Contact our Actos® injury lawyers today to schedule a free case evaluation.