Product Liability

Profits of diabetes drug Actos drop amid bladder cancer scare

Japan pharmaceutical company Takeda has announced a nosedive in first-half operating profits in the wake of new bladder cancer warnings on its top-selling type 2 diabetes pill Actos. The company posted a 4.8 percent drop in profits despite an April-September operating profit of ¥211 billion, the equivalent to about $2.7 billion.

Takeda says part of the blame rests on currency losses from a strong yen and generic competition. However, the new warnings placed on Actos labels in Europe and the United States have caused sales of the type 2 diabetes pill to wane.

New studies released within the past few months revealed that Actos may put users at risk for developing bladder cancer. The risk was more pronounced in patients who used the drug long term. Several European countries stalled sales of the drug  before ordering stronger warnings be placed on the drug’s label. The United States Food and Drug Administration (FDA) also placed stronger warnings on Actos labels and is conducting an ongoing review of adverse events associated with the drug.

Actos is the second type 2 diabetes drug in recent months to come under scrutiny by the FDA. Last year, the federal agency placed severe restrictions on the diabetes pill Avandia after studies showed the drug may put users at risk for fatal heart attacks.

The mounting problems for Takeda have resulted in the company slashing its operating-profit forecast for the business year to end-March 2012 to ¥270 billion from its initial estimate of ¥390 billion. Shares of Takeda have fallen about 13 percent since January 2010.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

AVANDIA is a registered trademark of GlaxoSmithKline.

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