The Latisse prescribing information (bimatoprost 0.03%, for eyelashes) lists eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema as the most frequently reported adverse reactions in its clinical trial. It states that "These reactions occurred in less than 4% of patients". The label also carries separate warnings, and it says reports gathered after approval cannot always establish frequency or cause.
Reactions in the label's clinical trial
The label bases its clinical trial information on a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for 4 months of treatment. It lists foreign body sensation, hair growth abnormal, and iris hyperpigmentation as additional adverse reactions seen in clinical trials experience. The quoted sentence gives no rate for those 3.
A separate randomized, double-masked, vehicle-controlled study of bimatoprost 0.03% for eyelashes reported that only conjunctival hyperemia occurred at a statistically significant higher incidence rate with bimatoprost than with vehicle (P = .03).
Reactions reported after approval
The label's postmarketing section lists these reactions identified during postapproval use:
- dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (label);
- rash (including macular and erythematous), skin discoloration (periorbital), skin exfoliation of the eyelid and/or periorbital area, trichiasis, and vision blurred (label);
- periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis (label).
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." So this list shows what was reported. It gives no frequency for any item.
Other warnings and precautions
| Question | What the source says |
|---|---|
| Active intraocular inflammation? | The label says to use with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. |
| Macular edema? | Macular edema, including cystoid macular edema, has been reported during treatment. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. |
| Bottle tip and applicators? | The bottle tip should not contact any other surface since it could become contaminated. Sterile applicators should only be used on 1 eye and then discarded, since reuse increases the potential for contamination and infections. |
| Bacterial keratitis? | There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. |
| Contact lenses? | The product contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Lenses should be removed prior to application and may be reinserted 15 minutes following administration. |
| Hypersensitivity? | The product is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients. |
| New eye problems? | Patients who develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, should immediately seek their physician's advice. |
| Hair growth outside the treated area? | The Latisse patient information says it is possible for hair growth to occur in other areas of your skin that Latisse frequently touches, and that any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this from happening. |
What this does not tell you
The postmarketing list gives no frequencies, and by the label's own statement it is not always possible to estimate frequency or establish cause from such reports. The label's trial figures come from 1 study lasting 4 months, so they do not describe longer use. The "less than 4%" statement covers 6 listed reactions together, not each one.
These statements describe 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 strength, sterility or quality as an approved one. A licensed provider decides whether treatment suits a person.