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PATIENT INFORMATION CONSENT
FELBATOL® (felbamate) SHOULD NOT BE USED BY
PATIENTS UNTIL THERE HAS BEEN A COMPLETE
DISCUSSION OF THE RISKS AND WRITTEN
INFORMED CONSENT HAS BEEN OBTAINED.
IMPORTANT INFORMATION AND WARNING:
Felbatol®, taken by itself or with other prescription
and/or non-prescription drugs, can result in severe,
potentially fatal blood abnormality (''aplastic anemia'')
and/or severe, potentially fatal liver damage.
PATIENT CONSENT:
My [My son, daughter, ward,
's]
treatment with Felbatol® has been personally explained
to me by Dr.
The following points of information, among others, have
been specifically discussed and made clear and I have
had the opportunity to ask any questions concerning
this information:
1. I,
(Patient's
Name), understand that Felbatol® is used to treat cer-
tain types of seizures and my physician has told me that
I have this type( s) of seizures;
INITIALS:
2. I understand that Felbatol® is being used since my
seizures have not been satisfactorily treated with other
antiepileptic drugs;
INITIALS:
3. I understand that there is a serious risk that I could
develop aplastic anemia and/or liver failure, both of
which are potentially fatal, by using Felbatol®;
INITIALS:
4. I understand that there are no laboratory tests which
will predict if I am at an increased risk for one of the
potentially fatal conditions;
INITIALS:
5. I understand that I should have the recommended
blood work before my treatment with Felbatol® is begun
or continued and then every 1-2 weeks while taking
Felbatol®. I understand that although this blood work
may help detect if I develop one of these conditions, it
may do so only after significant, irreversible and pote-
ntially fatal damage has already occurred;
INITIALS:
6. If I am currently taking another antiepileptic drug, I
understand that the manufacturer of Felbatol® recom-
mends that the dosage of these other drugs be
decreased by a certain amount when Felbatol® is
started; if my physician determines that this should not
be done in my case, he/she has explained the reason(s)
for this decision
INITIALS:
7. I understand that I must immediately report any
unusual symptoms to Dr.
and be especially aware of any rashes, easy bruising,
bleeding, sore throats, fever, and/or dark urine;
INITIALS:
I now authorize Dr.
to begin my treatment with Felbatol®; OR, if my
treatment has already begun with Felbatol® , to con-
tinue such treatment.
Patient, Parent, or Guardian
Address
Telephone
PHYSICIAN STATEMENT:
I have fully explained to the patient,
the nature and purpose of the treatment with Felbatol®
(felbamate) and the potential risks associated with that
treatment. I have asked the patient if he/she has any
questions regarding this treatment or the risks and have
answered those questions to the best of my ability. I also
acknowledge that I have read and understand the pre-
scribing information listed above.
Physician
date
NOTE TO PHYSICIAN: It is strongly recommended
that you retain a signed copy of the informed consent
with the patient's medical records.
SUPPLY OF PATIENT INFORMATION/ CONSENT FORMS:
A supply of "Patient Information/Consent" forms as
printed above is available, free of charge, from your
local Wallace representative, or may be obtained by
calling 609-655-6147. Permission to use the above
Patient Information/ Consent by photocopy reproduc-
tion is also hereby granted by Carter-Wallace, Inc.
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