| During the past year, a steady stream of women | | | | whether it is right for you. |
| (and a few men) have visited my office practice | | | | In addition to noticing the eyelash-lengthening effects |
| asking about the drug Latisse, a product that | | | | of Bimatoprost, ophthalmologists also reported a |
| darkens, lengthens, and thickens eyelashes, and | | | | tendency for the iris (colored part of the eye) to |
| whether it is safe to use. Before I discuss specific | | | | darken. Hazel and blue eyes may take on brown |
| information about this medicine, it is important to | | | | undertones. Brown eyes may become a deeper |
| understand what the term safe to use actually | | | | brown. This color change appears to be permanent, |
| means. | | | | as it does not change when the drug is discontinued. |
| The safety of medications is determined and | | | | While this is a tolerable side effect for a patient with |
| overseen in the United States by the Food and Drug | | | | glaucoma, when weighed against the prospect of |
| Administration (FDA). Actually, several other countries | | | | becoming blind, changes in iris color might not be |
| throughout the world also rely on the FDA's stringent | | | | acceptable to those using Bimatoprost for cosmetic |
| standards for drug safety. Before a drug can be | | | | lash-enhancing purposes. |
| approved for public use by the FDA, it must first | | | | Latisse is applied to the upper eyelid margins at the |
| successfully pass through a sequence of clinical trials | | | | base of the eyelashes. Under no circumstances |
| to establish its efficacy, effectiveness, and safety. If | | | | should it be applied to the lower lashes. There are |
| a drug meets this standard, it either will be approved | | | | several reasons for this. One of these is that this |
| for general use (over-the-counter) or restricted use | | | | drug can cause a darkening of the skin on the upper |
| (doctor's prescription required). A drug typically is | | | | eyelid. While eye makeup effectively can cover and |
| placed under restricted use if it is potentially | | | | blend alterations in eyelid color, changes in lower |
| dangerous if used incorrectly, if it carries the | | | | eyelid color are not aesthetically desirable. This is |
| possibility for misuse, if its side effects can be | | | | because the darkening will occur under the eye, an |
| potentially severe, or if more data needs to be | | | | area that already is prone to darkening for other |
| collected about the spectrum and intensity of its side | | | | reasons. Skin darkening on the upper (or lower) eyelid |
| effects. | | | | appears to be reversible if the medicine is stopped. |
| Latisse falls into the restricted category, meaning | | | | Latisse also has been reported to induce hair growth |
| that it only can be used under a doctor's supervision. | | | | on the face in areas where a drop of the drug may |
| The FDA has deemed this drug to be safe if used as | | | | have inadvertently fell. This is not a problem for the |
| directed, with the caveat that a person may | | | | upper eyelid, since gravity tends to pull any excess |
| experience side effects that can be mild to severe. | | | | medication away from the eyelid and into the eye. |
| However, this endorsement is based upon a | | | | However, if applied to the lower lid, gravity has a |
| statistical analysis of data gathered from clinical trials | | | | tendency to cause the drug to bleed into the skin |
| and cannot be applied directly to individual cases. | | | | under the eye. Thus, hair growth might be induced in |
| Thus, the critical question is if this product is safe for | | | | this area in addition to the lash line. This definitely |
| YOU. In truth, medical science cannot give you this | | | | would not be aesthetically pleasing. |
| guarantee, as each of us has a unique metabolic | | | | If properly applied to the upper eyelid, a sufficient |
| profile that is based upon genetics, physiology, | | | | amount of the drug will be transferred to the lower |
| lifestyle, and life circumstances. For this reason, it is | | | | lash line and induce some growth there as well. Thus, |
| important to monitor how you are reacting to a | | | | there is no need to apply Latisse directly to the |
| medicine and report any side effects that you | | | | lower eyelashes and many reasons not to do it. |
| experience to your physician, regardless of how trivial | | | | Other potential side-effects associated with this drug |
| they might seem to you at the time. | | | | include: |
| Now that we understand how the safety of | | | | - blurred vision |
| medicines is determined, let us address the product | | | | - eyelid redness |
| Latisse specifically. | | | | - eye discomfort |
| On December 5, 2008 the pharmaceutical company | | | | - temporary burning sensation during use |
| Allergan, Inc. received approval from the FDA to | | | | - infection if the one-time applicators that come with |
| market Bimatoprost ophthalmic solution under the | | | | Latisse are reused |
| trade name Latisse. Since its approval, use of Latisse | | | | - lashes may grow so long that they become |
| to enhance eyelash prominence has become a highly | | | | ingrown and scratch the cornea |
| popular cosmetic trend. | | | | Latisse only can be used under a doctor's supervision. |
| It is interesting to point out that although the Allergan | | | | It comes with disposable applicators that are |
| website promotes Latisse as a treatment for eyelash | | | | designed to be used once and then discarded. The |
| hypotrichosis (inadequate or insufficient quantity of | | | | medication is expensive, costing an average of $120 |
| eyelashes), the actual FDA approval only is for | | | | for a one-month prescription. The same drug sold as |
| cosmetic purposes. Recently, the FDA gave a formal | | | | an ophthalmic solution costs about half as much and |
| warning to Allergan, indicating that advertising for the | | | | some doctors are prescribing this to their patients. |
| product did not adequately disclose its potential side | | | | However, doing so raises the possibility of side |
| effects. I will clear up any confusion about its side | | | | effects, particularly infection, if the patient has to find |
| effects here. | | | | alternative means to substitute for the disposable |
| Originally sold under the trade name Lumigan by | | | | applicators that come with Latisse. Other alternatives |
| Allergan in North America and Europe, Bimatoprost | | | | also are being sold on the Internet. However, these |
| ophthalmic solution is a prostaglandin analog that | | | | have not passed through clinical trials to demonstrate |
| received FDA approval for the treatment of | | | | their effectiveness and safety. Although their lower |
| glaucoma and ocular hypertension (elevated pressure | | | | price may be attractive, I do not recommend using |
| inside the eye). However, ophthalmologists prescribing | | | | them. A generic form of Bimatoprost is being sold in |
| this medication noticed that it appeared to be | | | | Europe under the name Careprost. However, there |
| promoting the growth of longer, fuller, and darker | | | | do not appear to be clinical trials data available for |
| eyelashes in their patients. This prompted Allergan to | | | | this preparation and it has not been approved by the |
| investigate Bimatoprost as a potential cosmetic | | | | FDA. |
| preparation. | | | | I do not recommend using any product in or around |
| Since its introduction, more than one million | | | | your eyes that has not passed through the |
| prescriptions of Latisse have been filled. Interestingly, | | | | extensive testing that is required for FDA approval. |
| other prostaglandin analogs, such as Latanoprost | | | | Medications failing to meet these standards can have |
| (Xalatan) - manufactured by Pfizer - and Travoprost | | | | questionable purity, sterility, and consistency. They |
| (Travatan) - manufactured by Alcon - have similar | | | | may also contain additives that can cause undesirable |
| effects. Thus, other prescription lash-enhancing | | | | side effects. For example, corticosteroid additives |
| products likely will be emerging on the market soon. | | | | potentially can cause cataracts and elevations in |
| Clinical trials have demonstrated that Latisse is safe | | | | intraocular pressure that can lead to glaucoma. |
| when used as directed at the recommended dosage. | | | | In summary, Latisse is safe and effective if used as |
| However, those that are thinking about using this | | | | directed, but can have undesirable side effects in |
| drug should be aware of its potential side effects, so | | | | some people. |
| that you can make an informed decision about | | | | |