Posted by Tony C. on August 8, 2004, at 12:53:55
Nov. 3, 2003 (Boston) - A new study suggests that psychiatrists should
be careful when prescribing nefazodone (Serzone), but they "don't have
to panic" about reports that the antidepressant can cause liver
damage.Athi P. Venkatesh, MD, reviewed medical records of 1,853 patients who
took the drug from Jan. 1, 1999, to Dec. 31, 2001, at Scott and White
Hospital in Temple, Texas. After reducing the sample to 359 patients
who had liver function tests (LFT) performed, he reported that 3.9%
(95% confidence interval, 2.1% - 6.5%) had an elevation attributable
to nefazodone."In our population, we did not find any patients with severe or even
very severe LFT elevation," he told Medscape in an interview here at
the American Psychiatric Association's 55th Institute on Psychiatric
Services. Dr. Venkatesh reported his results in a poster at the
meeting.The U.S. Food and Drug Administration put a "black box" warning on
nefazodone on Dec. 7, 2001, after reports of liver failure in three
patients. Since then, psychiatrists have debated whether to prescribe
nefazodone, which causes less sexual dysfunction than some alternative
drugs and is useful for insomnia.In addition to the case reports, Dr. Venkatesh said he has found only
one study documenting liver damage from nefazodone, which was
published in the May 2002 issue of the Canadian Journal of Psychiatry.
He questioned the results, however, because the data did not exclude
patients with contributing medical conditions such as cirrhosis or
other medications that can cause an elevated LFT.In their retrospective study, Dr. Venkatesh and coauthor Antunes
Phillip, MD, found 162 patients with elevated LFTs. They accounted for
45% of those tested for liver function, but included 90 patients who
had high LFTs before being prescribed nefazodone.Removing those patients from the sample left 72 patients who had their
first elevated LFTs after starting nefazodone: a prevalence of 20%
(95% confidence interval, 16% - 25%). Most patients (71%) had mild
elevations. The rise was moderate in 15%, severe in 11%, and very
severe in 2%.Further review revealed that 58 of these patients had a medical
condition or took a medication associated with elevated LFT. This left
only 14 patients for whom the change could be blamed on nefazodone.
All had mild elevation, except for one increase classified as
moderate.Dr. Venkatesh concluded that psychiatrists could prescribe nefazodone,
if they use caution. "You have to keep in the back of your mind that
this drug can cause a mild elevation in LFT. So you do a baseline LFT
before starting nefazodone and monitor it by doing one in six months,"
he said.APA 55th Institute on Psychiatric Services: Abstract 100. Presented
Oct. 31, 2003.Reviewed by Gary D. Vogin, MD
(TONY C.)
poster:Tony C.
thread:375333
URL: http://www.dr-bob.org/babble/20040805/msgs/375333.html