FDA Responds to Actos Side Effects Reports, Orders On-going Study

ActosActos is a medication in the class of drugs known as thiazolidinediones (TZD) which help those with Type 2 diabetes regulate glucose levels. Although exercise and a healthy diet can help regulate blood sugar, medication is sometimes the only way some are able to control their diabetes.

Approved by the U.S. Food and Drug Administration (FDA) in 1999, Actos (pioglitazone hydrochloride), manufactured by Takeda Pharmaceuticals, has been tied to serious side effects including, bladder cancer, congestive heart failure, and bone fractures. Adverse event reports received by the FDA prompted the federal agency to order a 10 year safety review of the medication.  Meanwhile, adverse events have also prompted litigation as Takeda continues to be named in a growing number of Actos lawsuits filed nationwide.

FDA investigates Actos and bladder cancer link

Perhaps the most publicized of the reported Actos side effects concerns bladder cancer. In 2002, the FDA ordered an investigation into the alleged link between the drug and the side effect. Though the results of that Takeda-sponsored test remain to be seen, the federal agency did update the Actos warning and label in 2011 based on an analysis of the on-going safety review.

The update was limited in scope. The agency acknowledged that taking the medication for more than year may be associated with an increased risk of developing bladder cancer. The FDA further recommended that patients with active bladder not use the drug, and that those with a history of the disease, seriously weigh the benefits of treatment with the risk of disease.

Although the reason for the link remains unclear, some experts believe that pioglitazone affects DNA and other genetic processes and may lead to genetic mutation and defects that increase bladder cancer risks. Others believe that the body’s toxins, which are removed by the kidneys and filtered to the bladder, may increase the drug’s cancer-causing effects.

Conflicting test results among medical professionals continue to drive the debate surrounding the controversial medication. The FDA has promised a comprehensive review of an ongoing French study that prompted French authorities to issue an Actos recall within the country. International response has driven the drug out of the German market as well.


Other FDA action concerning Actos side effects

  • Congestive Heart Failure:   In 2007, the FDA mandated that Takeda add a black box warning to the Actos label regarding congestive heart failure and issued a safety communication stating, “continuation of [Actos] has been associated with poor outcomes, including death.” Healthcare professionals were advised to observe patients for signs and symptoms consistent with heart failure.
  • Bone Fractures:  In 2007, the FDA announced that patients taking Actos were at an increased risk for fracture. In 2010, a study published in the Journal of Clinical Endocrinology & Metabolism reinforced that warning, noting that 70% of people suffering from a bone fracture were also taking a TZD medication. Post-menopausal women were at even greater risk, as were patients taking Actos for more than one year.


Legal action in the wake of FDA scrutiny

Thousands of people who were treated with the drug for their Type 2 diabetes have reported injuries associated with Actos use, prompting the filing of lawsuits all over the country. Many of the plaintiffs allege that Takeda Pharmaceuticals knew, or should have known, about the serious risks associated with Actos and that the manufacturer failed to provide adequate warnings about them. Other causes of action include breach of warranty, fraud, and strict liability. Read more about Actos lawsuits.

In April 2013, one plaintiff was awarded a $6.5 million dollar verdict after developing bladder cancer. Though the verdict was later vacated, his legal counsel has announced that they will appeal the verdict. Meanwhile, thousands more await their own day in court.


About the Author: 

Lance Andrews is a reporter for Injury Lawyer News, exposing the effects of dangerous drugs, defective medical devices, and product recalls.  Lance uses his unique blend of medical training and journalism studies in favor of consumer protection and patient safety. Learn more about Actos litigation by visiting http://injurylawyer-news.com/actos/lawsuit/

Joan Evans (28 Posts)

Joan Evans is a mental health specialist and has a great interest in personality disorders. In her spare time she likes to go to the woods with her golden retriever, Leroy, and write fiction.