Just got this notice from the chief pharmacist at the hospital where I work. Wanted to pass it along. Anyone on this drug or who has a child on this drug for seizures should check with their doctor. This is NOT a hoax or an urban myth. This is a genuine information release directly from the drug manufacturer. There are phone numbers and website info at the bottom if you have more questions.
Yvonne

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Ortho-McNeil Pharmaceutical, Inc.
1000 Route 202, PO Box 300
Raritan, New Jersey 08869-0602
908 218-6000 Telephone

IMPORTANT DRUG WARNING

Dear Healthcare Professional:

We have updated the prescribing information for TOPAMAX® to provide new information
about an ocular syndrome that has occurred in patients receiving topiramate. This syndrome is
characterized by acute myopia and secondary angle closure glaucoma. This information is
based on postmarketing experience in more than 825,000 patients.
As of August 17, 2001 there have been 23 reported cases: 22 in adults and 1 in pediatric
patients. It is generally recognized that postmarketing data are subject to substantial underreporting.
Symptoms have typically occurred within the first month of therapy, with patients reporting an
acute onset of decreased visual acuity and/or ocular pain. Eye examination revealed myopia,
redness, shallowing of the anterior chamber and elevated ocular pressure, with or without pupil
dilatation. Supraciliary effusion may displace the lens and iris anteriorly, secondarily causing
angle closure glaucoma.
If patients develop this syndrome, the primary treatment to reverse symptoms is discontinuation
of TOPAMAX as rapidly as possible, according to the judgment of the treating physician.
Other measures, in conjunction with discontinuation of TOPAMAX, may be helpful.
The following has been added to the TOPAMAX prescribing information:
Under WARNINGS
Acute myopia and secondary angle closure glaucoma
A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has
been reported in patients receiving TOPAMAX. Symptoms include acute onset of decreased
visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber
shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or
may not be present. This syndrome may be associated with supraciliary effusion resulting in
anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms
typically occur within 1 month of initiating TOPAMAX therapy. In contrast to primary narrow
angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma
associated with topiramate has been reported in pediatric patients as well as adults. The
primary treatment to reverse symptoms is discontinuation of TOPAMAX as rapidly as
possible, according to the judgment of the treating physician. Other measures, in conjunction
with discontinuation of TOPAMAX, may be helpful.
Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae
including permanent vision loss.
Under PRECAUTIONS
Information for Patients
Patients taking TOPAMAX should be told to seek immediate medical attention if they
experience blurred vision or periorbital pain.
You can further our understanding of adverse events by reporting all cases to Ortho-McNeil at
the contact numbers below or to the FDA MedWatch Program by phone 1-800-FDA-1088,
by fax 1-800-FDA-0178, by mail (using postage-paid form) MedWatch, HF-2, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or via www.fda.gov/medwatch.
If you have any questions regarding TOPAMAX Tablets and TOPAMAX Sprinkle Capsules, please feel free
to call Ortho-McNeil Medical Affairs Division at 1-800-682-6532.
Sincerely,
Joseph Hulihan, MD
Director, CNS Research