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serum AST or serum ALT levels equal to or greater than 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug.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!
poster:JohnX2
thread:96775
URL: http://www.dr-bob.org/babble/20020301/msgs/96826.html