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FDA Issues Warning on Actos

The FDA has asked the makers of Actos to issue a black box warning–the very strongest warning possible–about the serious risk of cardiovascular-related deaths such as heart attacks and heart failure. 

Actos and related drug Avandia were the focus of a recent study conducted by prominent cardiologist Dr. Steven Nissen of the Cleveland Clinic. In his review of 42 studies involving Avandia and Actos, Nissen found that they increase the risk of heart attack by 42 percent, compared to the risk for those taking alternative diabetes drugs or a placebo.

Clinical evidence also shows that Actos significantly increases the risk of bone fracture in female patients, particularly fractures of the distal upper and lower limbs. Post-marketing studies have also shown that patients taking Actos are at an increased risk of suffering from related Actos hepatitis, Actos liver failure, inflammation of the liver, and elevated liver enzymes. Patients using Actos are urged to have their liver enzymes checked periodically.

Actos (generic name pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos and related drugs are used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone.
 
Patients who develop symptoms of Actos-related heart failure, heart attack, or other side effects should immediately contact their health care provider. Such symptoms may include an unusually rapid increase or decrease in weight, fluid retention (edema), shortness of breath, unexplainable fatigue and weakness, confusion and fatigue, and chest pain.

If you are taking Actos and are concerned about the risks posed by this medication, speak with your health care provider before changing your treatment regiment or stopping Actos. Patients who choose to continue use of Actos should be aware of the possible side effect risks and the symptoms of these complications.

In addition, if you have been hurt or injured by taking Actos, please contact one of our pharmaceutical drug lawyers as you may be entitled to compensation.  For over 35 years, the attorneys at Carr & Carr Attorneys has represented thousands of people in Oklahoma, Arkansas and across the country.

Posted by Michael

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