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Re: Where's this BLACK BOX on Serzone??

Posted by yachats on July 13, 2003, at 19:32:49

In reply to Re: Where's this BLACK BOX on Serzone??, posted by JohnX2 on March 6, 2002, at 23:25:33

The incidence of liver disease damage from Serzone may be much higher than the Black Box figures due to under-reporting. For example, a recent study concluded that the incidence of liver toxicity from Serzone was 28.96 cases per 100,000 patient years. That translates into 1 in 3,453 patient years.
J Clin Psychiatry 2002 Feb;63(2):135-7
Hepatotoxicity associated with the new antidepressants.
Carvajal GP, Garcia D, Sanchez SA, Velasco MA, Rueda D, Lucena MI.

Also, as the following quote from the August 2000 Harvard Mental Health Letter indicates, liver function tests may provide a false sense of security.
"Many physicians now order liver function tests before prescribing nefazodone and periodically during treatment. They are checking for damaged liver cells, which usually mend when the patient stops taking the drug. Unfortunately, the tests do not always accurately identify the damage, so patients must also watch for characteristic symptoms stomach pain, appetite loss, nausea, dark urine, yellowing skin and report them immediately."

Furthermore, medication-induced liver dysfunction differs from alcohol-related liver disease in that the condition does not always develop gradually over time but can come on quite suddenly. Thus monitoring liver function every few months may be insufficient to detect reversible damage in time.

You might also want to see the following study which found "32 reported cases of hepatotoxicity associated with nefazodone in Canada, 81.3% of which were severe," and which also note that "In common with similar databases, the CADRMP [Canadian Adverse Drug Reaction Monitoring Programme] database includes only a small proportion of suspected drug reactions.
Can J Psychiatry 2002 May;47(4):375-7 Related Articles, Links
Hepatic adverse reactions associated with nefazodone. Stewart DE
As others have pointed out, Serzone also has an increased risk of drug interaction problems due to enzyme inhibition. Of particular interest to patients on psych med is that Serzone inhibits the metabolism of bezodiazepines. Thus going on Serzone will increase one's benzo level and going off Serzone may result in benzo withdrawal symptoms.
I think the bottom line is that there are real risks associated with Serzone that are greater than the 1/250,000 number that people have used to rationalize its use. If its the only thing that works for you, then by all means stick with it. However, if you are someone who hasn't tried everything else first, I would suggest you do that before trying Serzone.




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