Medical Societies Respond to the FDA’s Safety Announcement on the Use of the Diabetes Medication Actos (pioglitazone)

Contact(s): Bryan Campbell
904-353-7878 x122
June 16, 2011

The Endocrine Society, American Association of Clinical Endocrinologists and American Diabetes Association urge diabetes patients to remain on their prescribed medications unless instructed otherwise by their healthcare provider.

Chevy Chase, MD – Diabetes leaders today are responding to the announcement made by the U.S. Food and Drug Administration (FDA) yesterday that the use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. According to the FDA’s Safety Announcement, information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

In response to this important safety announcement from the FDA, The Endocrine Society, the American Association of Clinical Endocrinologists and the American Diabetes Association urge patients who are currently taking Actos or any combination of medication that includes pioglitazone, to continue taking all currently prescribed medications unless instructed otherwise by their healthcare provider. Stopping diabetes medications can result in higher levels of blood glucose that may cause serious short-term health problems and could increase the risk of diabetes-related complications in the long-term.

The Endocrine Society, American Association of Clinical Endocrinologists and American Diabetes Association recommend that patients adhere to the following guidance provided by the FDA:
• There may be an increased chance of having bladder cancer when taking pioglitazone;
• Do not take pioglitazone if receiving treatment for bladder cancer;
• Talk to your doctor right away if you have any of the symptoms of bladder cancer including blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen;
• Read the Medication Guide included with pioglitazone medicine as it explains risks associated with the use of the drug; and
• Talk to your healthcare professional if you have questions of concerns about pioglitazone medicines.

According to the FDA Safety Announcement, the five-year interim analysis of an ongoing ten-year study showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients who had been on pioglitazone the longest and had been on higher doses over time.

The Endocrine Society, the American Association of Clinical Endocrinologists and the American Diabetes Association continue to support the FDA in its role as the regulatory agency that makes decisions regarding drug safety and efficacy.

Additional Resources:
FDA Safety Announcement
Takeda Statement
American Association of Clinical Endocriologists Notice to Membership

Founded in 1916, The Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit our site at www.endo-society.org.

The American Association of Clinical Endocrinologists (AACE) represents more than 6,500 endocrinologists in the United States and abroad. ACCE is the largest association of clinical endocrinologists in the world. The majority of AACE members are certified in Endocrinology and Metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. Visit our site at www.aace.com.

The American Diabetes Association is leading the fight to stop diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.