Actos Recall

actos recallActos is a prescription type 2 diabetes medication that has been on the U.S. market since 1999. Despite being linked to a number of fatal side effects, the U.S. Food and Drug Administration (FDA) has not recalled Actos. Instead, the FDA is carefully following ongoing studies that are being conducted in the United States and other countries. Studies have found that Actos is linked to side effects such as blindness, heart failure, and high rates of bladder cancer. Based on this information, France and Germany issued an Actos recall in 2011.

Actos was in close competition with Avandia, a type 2 diabetes drug made by GlaxoSmithKline. Avandia was associated with an increased risk of heart attacks. Soon after in 2007, Actos grew to be the best-selling type 2 diabetes drug in the world. In 2007, Actos manufacturer Takeda Pharmaceuticals earned roughly $4 billion in Actos sales.

Actos Side Effects

One of the most alarming side effects of Actos is the increased likelihood of developing bladder cancer. One study concluded that the risk of bladder cancer development is more than 80 percent higher in Actos patients. The risk of developing serious complications has been linked to prolonged treatment of one year or longer. Patients taking higher doses of Actos are also more likely to develop bladder cancer from treatment.

In addition to bladder cancer, Actos patients may also suffer heart failure. Heart failure occurs when the heart cannot sufficiently pump blood throughout the body. It can be an acute or chronic condition. In patients who have already experienced heart failure, Actos is known to exacerbate the condition. Actos may also cause heart failure in patients who did not previously suffer the condition.

Other serious side effects of Actos include liver failure, bone fractures, macular edema, and lactic acidosis. It is recommended that Actos patients seek immediate medical attention if they experience any unusual symptoms.

Actos FDA Warning

In June 2011, the FDA issued a Drug Safety Communication warning users of the increased risk of Actos bladder cancer in patients who use the drug for longer than one year. Additionally, warnings of bladder cancer were added to the Actos label under the “Warnings and Precautions” section. In addition to warnings regarding bladder cancer, the FDA also required a black-box warning for both Actos and Avandia stating the risks of congestive heart failure. This Avandia and Actos black-box warning was also issued in June 2011.

Actos Recall in France and Germany

The French Medicines Agency conducted its own safety review of Actos. The study concluded that Actos users were nearly 22 percent more likely to suffer bladder cancer than patients who used other medications. Shortly after the study was released, an Actos recall was issued by the French Agency for the Safety of Health Products, which is similar in function to the FDA.

Immediately after the French Actos recall, Germany’s Federal Institute for Drugs and Medical Devices also issued an Actos recall based on France’s findings. The countries have banned doctors from prescribing Actos due to the high risk of bladder cancer and other side effects. The European Medicines Agency (EMA) also acknowledges the link to bladder cancer and other serious side effects. However, the EMA has not issued an Actos recall or ban.

Actos Clinical Studies

Even before its release in 1999, there was evidence that Actos caused cancerous tumors in animals during lab testing. Takeda Pharmaceuticals soon launched a 10-year study in order to further examine the association with bladder cancer. The five-year results of the study did not show an overall increased risk of developing bladder cancer. However, patients who had the highest dosages of Actos for longer periods of time showed an increased risk.

View Sources
  1. Azoulay, Laurent, Hui Yin, et al. "The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study." British Medical Journal. 344. (2012). Web. 9 Apr. 2013. http://www.bmj.com/content/344/bmj.e3645
  2. "FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer." U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 15 Jun 2011. Web. 9 Apr 2013. http://www.fda.gov/drugs/drugsafety/ucm259150.htm
  3. Piccinni, Carlo, Domenico Motola, et al. "Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting." Diabetes Care. 34.6 (2011): 1369-1371. Web. 9 Apr. 2013. http://care.diabetesjournals.org/content/early/2011/04/20/dc10-2412
  4. "Update on ongoing European review of pioglitazone–containing medicines." European Medicines Agency. European Medicines Agency, 9 Jun 2011. Web. 9 Apr 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/06/news_detail_001275.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1