Medical Societies Respond to Actos Bladder Concerns

Diabetes drug, <"">Actos, has been making headlines for its links to increased bladder cancer risks, and, now, a few medical societies are speaking out about the findings. The Endocrine Society, American Association of Clinical Endocrinologists, and American Diabetes Association are urging patients with diabetes to remain on their prescribed medications unless they are told to discontinue that medication on the advice of their physicians said Science Daily.

Yesterday, we wrote that The U.S. Food & Drug Administration (FDA) had issued a Drug Safety Communication warning that people taking Actos (pioglitazone) for more than a year may face an increased risk of bladder cancer. The agency said the information on the possible association between Actos and bladder cancer will be added to the “Warnings and Precautions” section of the drug’s label. The patient Medication Guide will be revised to include bladder cancer risk information, said Science Daily.

Actos is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus. Pioglitazone is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). According to the FDA, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies From January 2010 through October 2010.

Science Daily explained that stopping diabetes medications could lead to increased blood glucose levels, which can lead to significant short-term problems and increase long-term diabetes-related complications.

The three medical societies suggest that patients follow FDA guidance, which advised that, when taking Actos, there is the potential for increased risk of bladder cancer and that patients should not take this medication if receiving bladder cancer treatment. The societies also suggest patients immediately speak to their physicians if they exhibit any bladder cancer symptoms, such as blood or red color in their urine, an urgent need to urinate, pain when urinating, or back or lower abdominal pain. Patients are also urged to read the Medication Guide supplied with Actos (pioglitazone) medication and to speak to their physicians if they have questions with this medication, said Science Daily.

According the FDA, the new Actos warning is based on its review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study that noted an increase risk of bladder cancer among patients with the longest exposure to Actos, and in those exposed to the highest cumulative dose. The FDA first informed the public of this finding in September 2010, when it began a safety review of Actos.

The FDA also said it has become aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with Actos. As we’ve reported previously, that study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the drug. The study found about a 22 percent higher risk of bladder cancer in those taking Actos compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.

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