IS LATISSE SAFE TO USE?Ophthalmologist Carolina Valdivia answers a question about Latisse from a 24 year-old woman interested in increasing the length of her eyelashes.  A 24 year-old woman from the USA writes:Hi Dr. Valdivia. Have you heard of the drug Latisse? It's supposed to make your lashes grow. I would like to have great looking lashes, but before I jump into this, I'd like to get the opinion of an expert. I've heard that it can do some weird things to your eyes. Is this true?
The safety of medications is determined and overseen in the United States by the Food and Drug Administration (FDA). Actually, several other countries throughout the world also rely on the FDA's stringent standards for drug safety. Before a drug can be approved for public use by the FDA, it must first successfully pass through a sequence of clinical trials to establish its efficacy, effectiveness, and safety. If a drug meets these standards, it either will be approved for general use (over-the-counter) or restricted use (doctor's prescription required). A drug typically is placed under restricted use if it is potentially dangerous if used incorrectly, if it carries the possibility for misuse, if its side effects can be potentially severe, or if more data needs to be collected about the spectrum and intensity of its side effects. Latisse falls into the restricted category, meaning that it only can be used under a doctor's supervision. The FDA has deemed this drug to be safe if used as directed, with the caveat that a person may experience side effects that can be mild to severe. However, this endorsement is based upon a statistical analysis of data gathered from clinical trials and cannot be applied directly to individual cases. Thus, the critical question is if this product is safe for YOU. In truth, medical science cannot give you this guarantee, as each of us has a unique metabolic profile that is based upon genetics, physiology, lifestyle, and life circumstances. For this reason, it is important to monitor how you are reacting to a medicine and report any side effects that you experience to your physician, regardless of how trivial they might seem to you at the time. Now that we understand how the safety of medicines is determined, let us address the product Latisse specifically. On December 5, 2008 the pharmaceutical company Allergan, Inc. received approval from the FDA to market Bimatoprost ophthalmic solution under the trade name Latisse. Since its approval, use of Latisse (Bimatoprost) to enhance the prominence of eyelashes has become a highly popular cosmetic trend.Whether intentional or not, it is good that you waited a while before considering to use this product. The time since FDA approval has allowed us to determine if any unanticipated side effects have emerged from the use of this drug for promoting the growth of eyelashes. Thus far, nothing unexpected has occurred. It is interesting to point out that although the Allergan website promotes Latisse (Bimatoprost) as a treatment for eyelash hypotrichosis (inadequate or insufficient quantity of eyelashes), the actual FDA approval only is for cosmetic purposes. Recently, the FDA gave a formal warning to Allergan, indicating that advertising for the product did not adequately disclose its potential side effects. I will clear up any confusion about its side effects here. Originally sold under the trade name Lumigan by Allergan in North America and Europe, Bimatoprost ophthalmic solution is a prostaglandin analog that received FDA approval for the treatment of glaucoma and ocular hypertension (elevated pressure inside the eye). However, ophthalmologists prescribing this medication noticed that it appeared to be promoting the growth of longer, fuller, and darker eyelashes in their patients. This prompted Allergan to investigate Bimatoprost as a potential cosmetic preparation. Since its introduction, more than one million prescriptions of Latisse have been filled. Interestingly, other prostaglandin analogs, such as Latanoprost (Xalatan) – manufactured by Pfizer – and Travoprost (Travatan) – manufactured by Alcon – have similar effects. Thus, other prescription lash-enhancing products likely will be emerging on the market soon.To answer your question, clinical trials have demonstrated that Latisse is safe when used as directed at the recommended dosage. However, those that are thinking about using this drug should be aware of its potential side effects, so that you can make an informed decision about whether it is right for you. In addition to noticing that Bimatoprost lengthens eyelashes, ophthalmologists also reported a tendency for the iris (colored part of the eye) to darken. Hazel and blue eyes may take on brown undertones. Brown eyes may become a deeper brown. This color change appears to be permanent, as it does not change when the drug is discontinued. This is a tolerable side effect for a patient with glaucoma. However, when weighed against the prospect of becoming blind, changes in iris color might not be acceptable to those using Bimatoprost for cosmetic lash-enhancing purposes. Latisse is applied to the upper eyelid margins at the base of the eyelashes. Under no circumstances should it be applied to the lower lashes. There are several reasons for this. One of these is that this drug can cause a darkening of the skin on the upper eyelid. While eye makeup effectively can cover and blend alterations in eyelid color, changes in lower eyelid color are not aesthetically desirable. This is because the darkening will occur under the eye, an area that already is prone to darkening for other reasons. Skin darkening on the upper (or lower) eyelid appears to be reversible if the medicine is stopped. Latisse (Bimatoprost) also has been reported to induce hair growth on the face in areas where a drop of the drug may have inadvertently fell. This is not a problem for the upper eyelid, since gravity tends to pull any excess medication away from the eyelid and into the eye. However, if applied to the lower lid, gravity has a tendency to cause the drug to bleed into the skin under the eye. Thus, hair growth might be induced in this area, in addition to the lash line. This definitely would not be aesthetically pleasing.If properly applied to the upper eyelid, a sufficient amount of the drug will be transferred to the lower lash line and induce some growth there as well. Thus, there is no need to apply Latisse directly to the lower eyelashes and many reasons not to do it. Other potential side-effects associated with Bimatoprost include:
A generic form of Bimatoprost is being sold in Europe under the name Careprost. However, there do not appear to be clinical trials data available for this preparation and it has not been approved by the FDA. I do not recommend using any product in or around your eyes that has not passed through the extensive testing that is required for FDA approval. Medications failing to meet these standards can have questionable purity, sterility, and consistency. They may also contain additives that can cause undesirable side effects. For example, corticosteroid additives potentially can cause cataracts and elevations in intraocular pressure that can lead to glaucoma. In summary, Latisse (Bimatoprost) is safe and effective if used as directed, but can have undesirable side effects in some people. Carolina Valdivia, MD
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