Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.8 Use with Contact Lenses
- ....contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
- ...The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.
6.2 Postmarketing Experience
- ...The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting possible causal connection to LATISSE, or a combination of these factors, include: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis .....
8 USE IN SPECIFIC POPULATIONS
8.4 Pediatric Use
- Use of LATISSE was evaluated in a sixteen week double-masked, randomized, vehiclecontrolled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. No new safety issues were observed. The results of the Global Eyelash Assessment are provided in Table 1.
17 PATIENT COUNSELING INFORMATION
17.8 Patient Counseling /Use with Contact Lenses of the Package Insert
- Advise patients that LATISSE solution contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of LATISSE and may be reinserted 15 minutes following its administration
- The following reactions have been identified during postmarketing use of Latisse in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting possible causal connection to Latisse, or a combination of these factors, include: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid irritation, eyelid edema, eyelids pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few lashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin discoloration (periorbital), and vision blurred.