PATIENT INFORMATION/CONSENT FORM

Cylert7 (pemoline) should not be used by patients until there has been a complete discussion of the risks and benefits of Cylert therapy and written informed consent has been obtained.

IMPORTANT INFORMATION:

Cylert therapy has been associated with liver abnormalities ranging from reversible liver function test increases that do not cause any symptoms to liver failure, which may result in death. Therefore, you should have a full discussion of the risks and benefits of Cylert before beginning therapy.

PATIENT CONSENT:

My (son, daughter, ward)___________________________=s treatment with Cylert has been explained to me by Dr.______________.

The following points of information, among others, have been specifically discussed and explained and I have had the opportunity to ask any questions concerning this information.

  1. I, ________(Patient/Parent/Guardian=s name), understand that Cylert is used to treat certain types of patients with the behavioral syndrome called attention deficit hyperactivity disorder (ADHD) and that I (my son/daughter/ward) am that type of patient.

    Initials:_______

  2. I understand that there is a risk that I (my son/daughter/ward) might develop liver failure, which may result in death, while taking Cylert. I understand that this could occur even after long-term therapy.

    Initials:______

  3. I understand that I (my son/daughter/ward) should have blood taken to test liver function before Cylert is begun, and every two weeks from then on while taking Cylert. I understand that although the liver function tests may help detect if I (my son/daughter/ward) develop liver damage, it may do so only after significant, irreversible and potentially fatal damage has already occurred.

    Initials:______

  4. I understand that if I (my son/daughter/ward) stop taking Cylert and then restart it at a later time (e.g., after summer vacation), I (my son/daughter/ward) should again have blood taken to test liver function before Cylert is restarted, and every two weeks from then on while taking Cylert.

    Initials:______

  5. I understand that I should immediately report any unusual symptoms to the doctor and should be especially aware of persistent nausea, vomiting, fatigue, lethargy, loss of appetite, abdominal pain, dark urine, or yellowing of the skin or eyes.

    Initials:______

I now authorize Dr._____________________ to begin my (son/daughter/ward=s) treatment with Cylert, or if treatment with Cylert has already begun, to continue this treatment.

_______________________________________

Signature/Date

_______________________________________

Address

_______________________________________

City/State/Zip

(_____)__________________________________

Telephone

PHYSICIAN STATEMENT:

I have fully explained to the patient (parent/guardian), _______________________ the nature and purpose of treatment with Cylert and the potential risks associated with that treatment. I have asked if he/she has any questions regarding this treatment or the associated risks and have answered these questions to the best of my ability.

_______________________________________

Physician Signature/Date

NOTE TO PHYSICIAN:

It is strongly recommended that you retain a completed copy of this informed consent form in your patient=s records.

SUPPLY OF PATIENT INFORMATION/CONSENT FORMS:

A supply of Patient Information/Consent Forms as printed above is available, free of charge, by calling (847) 937-7302. Permission to use the above Patient Information/Consent Form by photocopy reproduction is hereby granted by Abbott Laboratories.