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SERZONE ® -
The Sexy Anti-Depressant Drug is Causing Liver Failure
and Deaths
Serzone,® from Bristol-Myers Squibb, is advertised as the
Anti-Depressant that won't affect your sex drive, but it may
have a fatal attraction to your liver. On January 9, 2002,
MedWatch, the FDA Safety Information and Adverse Event Reporting
Service, notified all Health Care Professionals that it had
added a Black Box WARNING and strengthened the CONTRAINDICATIONS,
and PRECAUTIONS sections of the label for Serzone® (nefazodone
hydrochloride), a Seritonin Reuptake Inhibiting anti-depressant
drug.
After
more than 7.2 million prescriptions, Serzone® has been
found to cause liver failure leading to transplant and/or
death. 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.
If all
7.2 million Serzone® users took the drug for one year,
24-29 of them would be dead. That doesn't sound like very
many, unless it happens to be you or a loved one. How many
others have been seriously harmed and possibly left with
chronic liver dysfunction or failure is not reported.
Why has
the media not reported these deaths, yet are eager to headline
an unsubstantiated claim that an herb, known as Kava, has
caused liver toxicity and possibly 1 death in 24 individuals
in Germany and Switzerland. Why does the FDA require a
new Box WARNING for the Serzone® Physician information
that lists 1 death for every 250,000 to 300,000 patient-years
of use as a mere mathematical event, and never even lists
the possibility of death in the patient information.
The
new patient insert for Serzone® merely says: "The most
common side effects of Serzone® are sleepiness, dry mouth,
nausea, dizziness, constipation, weakness, lightheadedness,
problems with vision, and confusion. Call your doctor right
away if you have any of the following side effects:
- Yellowing
of the skin or whites of eyes (jaundice)
- Unusually
dark urine
- Loss
of appetite that lasts several days or longer
- Severe
nausea
- Abdominal
(lower stomach) pain
- Rash
or hives
- Seizure
(convulsion)
- Fainting
- Erection
that lasts too long
Since
when is death accepted as a mere mathematical event in
the case of a drug and not even mentioned as a possible
side-effect in the patient insert? How many deaths are
acceptable in the defense of a drug? Why does the FDA allow
any drug that kills people to stay on the market? Who gave
the FDA the authority to decide that a "few" deaths out
of so many are acceptable?
I predict
that Serzone® will eventually be taken off of the market 9
this drug has been banned in Canada), but not before 90-100
deaths have occurred. That appears to be the currently acceptable
number of deaths the FDA allows, but the number rises every
year. There are safer, natural alternatives to Serzone®.
I recommend taking St. John's Wort. It has been clinically
proven to be effective for moderate as well as severe depression
and won't harm your sex life or your liver.
For
more information about St. John's Wort, click
here |
