Posted by Nefazodone Man on September 7, 2007, at 17:39:32
Nefazodone Revisited on Liver Function
Jane Salodof MacNeil
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.
poster:Nefazodone Man
thread:781457
URL: http://www.dr-bob.org/babble/20070831/msgs/781457.html