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Type 2 Diabetes Drug Actos and Liver Failure

Posted by on Friday, July 20, 2012, 7:06
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While Actos (pioglitazone) is almost notorious for its bladder cancer link, it is also associated with another debilitating health condition: liver failure.

Type 2 Diabetes Drug Actos and Liver Failure

Type 2 Diabetes Drug Actos and Liver Failure

Liver failure happens when the liver loses its ability to carry out its normal function. Chronic liver disease or cirrhosis is the 12th leading cause of death in the United States. In 2009, the National Center for Health Statistics recorded 30, 558 deaths due to the disease.

It is still unknown whether liver failure is a common side effect of all thiazolidinediones (TZDs). Another TZD, Rezulin (troglitazone), was withdrawn from the U.S. market in 2000 because of liver failure problems. Avandia (rosiglitazone) is the only TZD that has yet to be linked to liver disease. The drug, however, is highly associated with a 43 percent increased risk for congestive heart failure (CHF). Diseases of the heart are the leading cause of death in the country.
Premarketing trials revealed that Actos could cause a rise in the alanine aminotransferase (ALT) enzyme three times above the normal level. An increase in ALT is a sign of heart problems, kidney dysfunction and liver damage. This means that prior to the introduction of Actos in 1999, its maker, Takeda, likely knew about some of the Actos-liver failure risk.
While the Actos-liver failure link is known, no massive deaths due to the disease have been reported except for one case described in the British Medical Journal (BMJ) in 2004. In a recent development, a growing number of Actos users are reportedly developing hepatic cirrhosis.

In a post-marketing study conducted by eHealthMe with 24,025 diabetes patients taking Actos, 105 developed hepatic cirrhosis.

Physicians are advised to avoid the prescription of Actos to patients who have liver disease and/or have experienced an increase in ALT. They are also advised to measure a type 2 patient’s ALT levels before the start of Actos therapy. Activities of the liver enzyme should also be examined regularly while taking Actos.

Symptoms for liver failure include itching, dark urine, excessive fatigue, jaundice, mental confusion, unusually pale bowel movements, and fluid retention in the abdomen. If you are taking Actos and are experiencing one of the symptoms, consult your doctor immediately.

Actos became the most prescribed type 2 diabetes drug when rival Avandia underwent extreme scrutiny in 2007 after studies pinned the latter drug to significant CHF risk.

Actos became the most aggressively endorsed diabetes drug. This happened even after the Food and Drug Administration (FDA) merited Actos a black-box warning for CHF in the same year it was given to Avandia. A black-box warning is the FDA’s toughest measure against prescription drugs that are proven to cause serious or deadly side effects.

In 2011, three large-scale studies also linked Actos to bladder cancer, one of the top causes of cancer deaths in the country. While Actos is still enjoying a free pass in the United States, two more studies were published this year corroborating the Actos-bladder cancer link. Bladder cancer is the impetus behind a growing number of Actos lawsuits, which are currently being gathered in Lafayette, La.
Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.

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