Label Changes for:

Latisse (bimatoprost) ophthalmic solution

September 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011

 

ADVERSE REACTIONS

Postmarketing Experience
  • 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.
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