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#2
A Case of Liver
Injury Reported After Pioglitazone Use
A Warning to remind you to order that liver test!
After 6 months of pioglitazone therapy, a 49-year-old diabetic man
developed serious liver injury that appeared to be caused by use
of the drug, according to a report published in the March 19th
issue of the Annals of Internal Medicine.
The drug, which is produced by Lincolnshire, Illinois-based Takeda
Pharmaceuticals North America under the brand name Actos, is the
newest thiazolidinedione hypoglycemic agent.
While this is only the second reported case of liver injury
following pioglitazone use, Dr. Louis D. May, from the
Gastrointestinal Associates of Rockland in New City, New York, and
colleagues suggest that patients treated with the medication
should be monitored for evidence of hepatitis.
The investigators describe the clinical course of 49-year-old man
with type 2 diabetes who developed significant hepatic dysfunction
after 6 months of pioglitazone therapy. The patient's initial
symptoms included anorexia, nausea, and upper abdominal
discomfort, the researchers note. A few weeks later, he developed
icteric sclera and acholic stools. The patient's hepatic function
tests were severely abnormal.
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. Furthermore, the patient's liver
enzyme values returned to normal after pioglitazone
discontinuation.
"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.
In a related editorial, Dr. David W. Nierenberg, from Dartmouth
Medical School in Hanover, New Hampshire, comments that "it now
appears highly probable (but not definite) that pioglitazone can
cause symptomatic, mild-to-moderate drug-induced hepatitis." More
patient data will need to be accumulated before the actual
frequency of this reaction is known, he adds.
Takeda and Lilly issued a statement today, 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.
"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," the statement
continued.
"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.
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FACT:
Forty-three
percent of all adults suffer adverse health effects due to stress
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