Actos Lawsuit Information

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According to a recent U.S. Food and Drug Administration (FDA) safety announcement, “use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.” The safety announcement explains that this risk information will soon be added to the “Warnings and Precautions section of the label for pioglitazone-containing medicines.” In addition, the FDA explains that “the patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”

This recent safety announcement comes after a recent study conducted in France which suggests an increased risk of bladder cancer with the use of Actos and related prescription medications. The FDA reports that France has already suspended the use of Actos, known generically as pioglitazone, and Germany has recommended not to begin Actos use with new patients. In the United States, the FDA has responded by initially recommending healthcare professionals not prescribe this medication to patients with active bladder cancer or a prior history of this condition.

Actos Use

Actos is a prescription medication used to treat Type 2 diabetes in adults over the age of 18. The use of this drug is meant to coincide with proper diet and exercise. The FDA explains that this medication is intended for use by itself as a means of treating or preventing diabetes, as well as a combination drug with the other medications, such as metformin and glimepiride. The FDA approved the sale of Actos in 1999, while a generic form is currently scheduled for release in 2012.  

In Type 2 diabetes, either the pancreas cannot produce enough insulin or cannot use it effectively enough to control the level of glucose in the blood. Actos’ active ingredient, pioglitazone, allows the body to make better use of the insulin it produces by making fat, muscle and liver cells more sensitive to it. This allows for the reduction of blood glucose levels and control over Type 2 diabetes.

Actos Bladder Cancer Risks

Actos’ risk of bladder cancer is particularly high in men. The FDA reports this “safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study.” According to this interim analysis, patients who used Actos for more than one year were far more likely to develop bladder cancer than those who were not using the drug or had just begun using it. The FDA reported that the risk was 40% greater for patients using Actos for more than one year.

The medication is also linked to a number of other side effects which include the following:

• Upper respiratory tract infection

• Hypoaesthesia, or diminished sense of touch

• Vision difficulties

• Bone fractures

• Increased weight

Furthermore, the FDA safety announcement warns patients to speak to their doctor if they have any of the following symptoms of bladder cancer while taking Actos: “blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.”

FDA Response

In response, the FDA plans to work closely with the Japanese pharmaceutical company which manufactures the drug - Takeda, Inc. - as it monitors the results of ongoing studies. Furthermore, the FDA has said it plans to review of the results from the French study that prompted both France and Germany to largely eliminate Actos from their markets. The FDA explains it will also continue updating the public on the dangers of this drug as more information becomes available.

About the Manufacturer

This research-based global pharmaceutical company is the largest pharmaceutical company in Japan. It also has operations throughout the U.S., including corporate facilities in California, New Jersey and Maryland, among others. However, Takeda’s United States Corporate headquarters are located in Deerfield, Illinois.

Last year alone, the company’s global sales revenue for Actos was $4.8 billion, accounting for over 27% of the company’s total pharmaceutical revenues. Furthermore, the FDA explains that between January 2010 and October 2010, an estimated 2.3 million diabetic patients in the U.S. alone filled prescriptions for this medication.

Reference:

U.S. Food and Drug Administration