Irwin & Boesen - Denver, Colorado Trial Attorneys

Pharmacological studies indicate that Actos improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Actos improves glycemic control while reducing circulating insulin levels. Pioglitazone belongs to a class of drugs called thiazolidinediones, which help lower blood sugar, or glucose, in people with type 2 diabetes mellitus.

Pioglitazone is the newest type of thiazolidinedione approved for use in the US. The drug company, Lilly, co-markets the drug with the maker, Takeda Pharmaceuticals North America. In 2000, the thiazolidinedione drug troglitazone (Rezulin) was taken off the market in the US and Europe after it was linked to dozens of deaths and cases of severe liver damage.

According to a report published in the March 19th issue of the Annals of Internal Medicine, a 49-year-old diabetic man taking Actos developed liver damage after taking the drug for 6 months. Blood tests excluded the possibility of a viral, metabolic, or autoimmune disorder, the authors state. Analysis of hepatic tissue revealed a mixed hepatocellular-cholestatic injury pattern consistent with drug toxicity.

After discontinuing use of Actos, his liver returned to normal. Although this case does not prove that Actos was the cause, Dr. Louis D. May of Gastrointestinal Associates of Rockland, New York, and colleagues suggest that patients treated with the medication should be monitored for evidence of hepatitis. "Physicians should be aware that this frequently prescribed agent is potentially hepatotoxic," Dr. May and colleagues write. “Careful monitoring for liver dysfunction, particularly during the first year of therapy, is warranted”, they add. The patient's initial symptoms included anorexia, nausea, and upper abdominal discomfort, as stated by the researchers. A few weeks later, he developed icteric sclera and acholic stools. The patient's hepatic function tests were severely abnormal.

In a similar case Dr. David W. Nierenberg, from Dartmouth Medical School in Hanover, New Hampshire, comments, "It now appears highly probable (but not definite) that pioglitazone can cause symptomatic, mild-to-moderate drug-induced hepatitis." He adds, “More patient data will need to be accumulated before the actual frequency of this reaction is known”.

A statement was issued by Takeda and Lilly, pointing out that any adverse events related to Actos use are reported to the FDA, and any cases involving questions of liver function are further evaluated by an independent panel of hepatologists. The statement continued, "To date, Actos has been prescribed to more than 2 million patients (12 million Rxs and over 1 million patient years of use) and the experience in regard to safety matches well with U.S. placebo-controlled clinical trials with Actos in which there was no evidence of drug-induced liver toxicity".

"Pending the availability of the results of additional large, long-term controlled clinical trials and additional, post-marketing safety data, current package labeling recommends that patients treated with Actos have their liver enzymes monitored at baseline, every 2 months for the first year and periodically thereafter. Actos should not be used in patients with active liver disease." Ann Intern Med 2002;136:449-452,480-483.

The New York Times stated in May of 2000 that “Doctors warn patients taking new drugs Avandia and Actos, both approved last year for type 2 diabetes, should be monitored carefully for potential liver damage; similar drug Rezulin was taken off market by FDA”.

Irwin & Boesen represents persons who have been injured by dangerous drugs. Please contact us for an honest and fair evaluation of your case.