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Changes to the skin and fat around the eye: what the label and studies report

The Latisse prescribing information (bimatoprost 0.03%, for eyelashes) lists "periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis" among reactions identified after approval. The label says such reports are voluntary, so frequency and cause cannot always be established. Observational reports and a review also discuss these changes, and each is described below with its design.

What the label lists after approval

Besides the fat and sulcus changes above, the postmarketing section lists dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis. It also lists rash (including macular and erythematous), skin discoloration (periorbital), skin exfoliation of the eyelid and/or periorbital area, trichiasis, and vision blurred.

A 2023 clinical review abstract describes madarosis as complete or partial loss of eyebrow or eyelash hair. Another 2023 review states that acquired eyebrow and eyelash loss may be due to a variety of underlying local or systemic disease processes, and in other cases it may be idiopathic.

The label explains: "Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure." The quoted sentence about fat atrophy and skin tightness gives no rate and does not say whether those changes reverse.

What studies and reviews report

QuestionWhat the source says
2014 retrospective observational case series of bimatoprost, latanoprost and travoprost groups (concentrations and eyelash use not stated): what was found?The frequency of deepening of the upper lid sulcus was 80% in the bimatoprost group, 15.7% in the latanoprost group and 45% in the travoprost group. The authors conclude that prostaglandin-associated periorbitopathy is as common as other adverse effects when careful examinations are performed and is more frequent and more severe in bimatoprost users.
2010 report of 2 patients on topical bimatoprost for glaucoma (concentration not stated): what was concluded?The title refers to recovery of orbital fat pad prolapsus and deepening of the lid sulcus. The conclusion states that these adverse effects may not be completely reversible after discontinuation of the medication.
2021 literature review of prostaglandin analog eyelash growth products: what did it conclude?The review concludes that clinical trials of bimatoprost for eyelash growth may have systematically underreported the incidence of drug application discomfort and prostaglandin-associated periorbitopathy. It also says the literature on bimatoprost for eyelash hypotrichosis is dominated by industry-sponsored clinical trials.

The case series and the 2-patient report are observational, so they cannot show cause and effect.

What the sources say about frequency and reversibility

The sources use these words themselves. The 2014 case series says prostaglandin-associated periorbitopathy is "as common as other adverse effects when careful examinations are performed". The 2010 report says the adverse effects "may not be completely reversible after discontinuation of the medication". The label says pigment changes have been "reported to be reversible upon discontinuation of bimatoprost in most patients". That sentence is about pigment only. The quoted label sentence on fat and sulcus changes says nothing like it. None of these sources states a rate for these changes in eyelash use.

What this does not tell you

The case series does not say whether use was for eyelash treatment or give concentrations, and the 2-patient report gives no concentration. Neither can be matched to a specific product. The percentages in the case series compare groups using different drugs, so they cannot be read as a rate for eyelash use. Reports collected after approval give no frequency and cannot always show cause.

The label describes the approved Latisse product. The FDA states that "Compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed." Nothing here shows that a compounded product has the same effect on the skin and fat around the eye as an approved one. A licensed provider decides whether treatment suits a person.

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