Psycho-Babble Medication Thread 96775

Shown: posts 1 to 5 of 5. This is the beginning of the thread.

 

Where's this BLACK BOX on Serzone??

Posted by Janelle on March 6, 2002, at 18:46:00

Is the so-called "BLACK BOX" on Serzone on the package insert that would come with samples? I got a prescription for Serzone at the pharmacy but there's no "black box" anywhere on the label. What's the story with this black box? Thanks!

 

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

Posted by Sunnely on March 6, 2002, at 21:57:31

In reply to Where's this BLACK BOX on Serzone??, posted by Janelle on March 6, 2002, at 18:46:00

You probably will not see the BLACK BOX Warning yet with the samples of Serzone.

In a nutshell, the FDA warned physicians and patients of the potential risk for liver injury while taking SERZONE.

The following is the BLACK BOX WARNING for SERZONE:

"WARNING
Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE.

The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of SERZONE treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (SEE WARNINGS.)

Ordinarily, treatment with SERZONE should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

SERZONE should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS: Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels equal to or greater than 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE is reintroduced. Accordingly, such patients should not be considered for re-treatment."

If you get any of the following symptoms while taking SERZONE, call your doctor right away because you may be developing a liver problem:

1. Yellowing of the skin or whites of eyes (jaundice)
2. Unusually dark urine
3. Loss of appetite that lasts several days or longer
4. Nausea
5. Abdominal (lower stomach) pain

People who currently have liver problems should not take SERZONE.


> Is the so-called "BLACK BOX" on Serzone on the package insert that would come with samples? I got a prescription for Serzone at the pharmacy but there's no "black box" anywhere on the label. What's the story with this black box? Thanks!

 

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

Posted by JohnX2 on March 6, 2002, at 23:25:33

In reply to Re: Where's this BLACK BOX on Serzone?? » Janelle, posted by Sunnely on March 6, 2002, at 21:57:31


I'm taking serzone. I did the math on the
odds if you take the below stats at face value.
If I take the medicine for 10 yrs, which I
won't, I have about a 1 in 25,000 chance of
getting liver disorder from Serzone.
I don't know how that compared to other
medicines/alcohol/etc.

-John


> You probably will not see the BLACK BOX Warning yet with the samples of Serzone.
>
> In a nutshell, the FDA warned physicians and patients of the potential risk for liver injury while taking SERZONE.
>
> The following is the BLACK BOX WARNING for SERZONE:
>
> "WARNING
> Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE.
>
> The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of SERZONE treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (SEE WARNINGS.)
>
> Ordinarily, treatment with SERZONE should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.
>
> Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.
>
> SERZONE should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS: Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels equal to or greater than 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE is reintroduced. Accordingly, such patients should not be considered for re-treatment."
>
> If you get any of the following symptoms while taking SERZONE, call your doctor right away because you may be developing a liver problem:
>
> 1. Yellowing of the skin or whites of eyes (jaundice)
> 2. Unusually dark urine
> 3. Loss of appetite that lasts several days or longer
> 4. Nausea
> 5. Abdominal (lower stomach) pain
>
> People who currently have liver problems should not take SERZONE.
>
>
> > Is the so-called "BLACK BOX" on Serzone on the package insert that would come with samples? I got a prescription for Serzone at the pharmacy but there's no "black box" anywhere on the label. What's the story with this black box? Thanks!

 

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

Posted by Waterlily on March 7, 2002, at 7:55:18

In reply to Where's this BLACK BOX on Serzone??, posted by Janelle on March 6, 2002, at 18:46:00

Hepatic (liver) failure is a rare side effect of Serzone. I just started Serzone on Friday night. My doctor had me get my blood drawn for a liver function panel to get a baseline before I started taking it. Should I stay on Serzone, he will have me get my blood drawn every 6 months to moniter the liver function values. If they change, he will probably take me off the medication. He says that monitering the levels will allow him to catch the liver failure before it becomes a problem.

 

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." http://www.health.harvard.edu/medline/Mental/M0802e.html

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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