6 ADVERSE REACTIONS
The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:
- Iris pigmentation changes [see Warnings and Precautions (5.1)]
- Eyelid skin darkening [see Warnings and Precautions (5.1)]
- Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2)]
- Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3)]
- Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4)]
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.
|Symptom/Finding||Adverse Reactions (incidence (%))|
|Foreign body sensation||13||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.
|Adverse Reactions (incidence (%))|
|Ocular Events/Signs and Symptoms|
|Eyelid margin crusting||3||3|
|Erythema of the eyelid||3||2|
|Upper respiratory tract infection/nasopharyngitis/influenza||3||3|
|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