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XALATAN® (latanoprost) Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.

Table 1: Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5–15% of Patients Receiving Latanoprost
Symptom/Finding Adverse Reactions (incidence (%))
Latanoprost
(n=460)
Timolol
(n=369)
Foreign body sensation 13 8
Punctate keratitis 10 9
Stinging 9 12
Conjunctival hyperemia 8 3
Blurred vision 8 8
Itching 8 8
Burning 7 8
Increased pigmentation of the Iris 7 0

Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Table 2: Adverse Reactions That Were Reported in 1–5% of Patients Receiving Latanoprost
Adverse Reactions (incidence (%))
Latanoprost
(n=460)
Timolol
(n=369)
Ocular Events/Signs and Symptoms
  Excessive tearing 4 6
  Eyelid discomfort/pain 4 2
  Dry eye 3 3
  Eye pain 3 3
  Eyelid margin crusting 3 3
  Erythema of the eyelid 3 2
  Photophobia 2 1
  Eyelid edema 1 3
  Blepharitis 1 3
Systemic Events
  Upper respiratory tract infection/nasopharyngitis/influenza 3 3
  Myalgia/arthralgia/back pain 1 0.5
  Rash/allergic skin reaction 1 0.3

6.2 Postmarketing Experience

The following reactions have been identified during postmarketing use of XALATAN in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, 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:

Nervous System Disorders: Dizziness; headache; toxic epidermal necrolysis

Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva.

Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea

Skin and Subcutaneous Tissue Disorders: Pruritus

Infections and Infestations: Herpes keratitis

Cardiac Disorders: Angina; palpitations; angina unstable

General Disorders and Administration Site Conditions: Chest pain

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