Adverse events referred to in other sections of this insert:
Eyelash changes (increased length, thickness, pigmentation, and number of lashes);
eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation
changes; and macular edema, including cystoid macular edema (see WARNINGS
and PRECAUTIONS).
Controlled Clinical Trials:
The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of
the patients on XALATAN Sterile Ophthalmic Solution in the three 6-month, multi-center,
double-masked, active-controlled trials were blurred vision, burning and stinging,
conjunctival hyperemia, foreign body sensation, itching, increased pigmentation
of the iris, and punctate epithelial keratopathy.
Local conjunctival hyperemia was observed; however, less than 1% of the patients
treated with XALATAN required discontinuation of therapy because of intolerance
to conjunctival hyperemia.
In addition to the above listed ocular events/signs and symptoms, the following
were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain,
lid crusting, lid discomfort/pain, lid edema, lid erythema, and photophobia.
The following events were reported in less than 1% of the patients: conjunctivitis,
diplopia and discharge from the eye.
During clinical studies, there were extremely rare reports of the following: retinal
artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy.
The most common systemic adverse events seen with XALATAN were upper respiratory
tract infection/cold/flu, which occurred at a rate of approximately 4%. Chest pain/angina
pectoris, muscle/joint/back pain, and rash/allergic skin reaction each occurred
at a rate of 1 to 2%.
Clinical Practice:
The following events have been identified during postmarketing use of XALATAN in
clinical practice. Because they are reported voluntarily from a population of unknown
size, estimates of frequency cannot be made. The events, which have been chosen
for inclusion due to either their seriousness, frequency of reporting, possible
causal connection to XALATAN, or a combination of these factors, include: asthma
and exacerbation of asthma; corneal edema and erosions; dyspnea; eyelash and vellus
hair changes (increased length, thickness, pigmentation, and number); eyelid skin
darkening; herpes keratitis; intraocular inflammation (iritis/uveitis); keratitis;
macular edema, including cystoid macular edema; misdirected eyelashes sometimes
resulting in eye irritation; dizziness, headache, and toxic epidermal necrolysis.