Actos Quick Reference Guide: Side Effects and Warnings for Pioglitazone Users, Lecture notes of Communication

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Thornton Naumes, LLP

ACTOS QUICK REFERENCE

GUIDE

Off-label side effects caused by Actos

Actos (pioglitazone), manufactured by Takeda Chemical Industries and co-marketed by Eli Lilly and Company, is in a class of diabetes drugs called thiazolidinediones or glitazones. Actos is manufactured in 3 strengths in tablet form: 15 mg, 30 mg, and 45 mg.

People with Type II diabetes take Actos to control blood sugar levels.

Actos is a glucose-lowering drug that increases the body's sensitivity to insulin.

What side effects does Actos cause that weren’t on the original warning label?

 Bladder cancer

In August of 2011, the U.S. Food and Drug Administration (FDA) approved updated drug labels for Actos and other pioglitazone-containing medicines to include warnings that using pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

Several studies showed an increased risk of bladder cancer with use of Actos. In June 2011, the FDA issued a Drug Safety Communication that warned that the use of this medication for more than one year has been associated with an increased bladder cancer risk. Six months later, the FDA approved updated labels for Actos to advise of the risk.

Medical regulators in France and Germany banned Actos in June 2011 because of the possibility of a bladder cancer risk. The decision was based on a French Medicines Agency study that found that people taking Actos were more likely to develop bladder cancer. The study examined cancer rates in about 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 diabetics taking the drug compared with those taking other drugs. The bladder cancer risk was highest in those receiving a cumulative dosage of at least 28,000 mg.

An earlier 2011 study examining more than 500,000 adverse event reports to the FDA between 2004- 2009 suggested that Actos patients faced a "disproportionate risk” of bladder cancer. The study looked at reports associated with various diabetes medications and found that one-fifth of those involving bladder cancer occurred in patients using the drug.

 Heart disease

In addition to bladder cancer, the American Heart Association and American Diabetes Association warned diabetics who have mild heart disease or kidney problems that they might be at risk for congestive heart failure if they take thiazolidinediones. The FDA required Actos to carry a Boxed warning about congestive heart failure and other cardiac risks in 2007.