Kenneth Steinsapir, M.D.
Beverly Hills, CA
Yes, you read that right. You have a bad romance with your lash growth product! Yes, the one you love. The one that is giving you amazingly longer, thicker, and darker eyelashes is also causing your eyelids to prematurely age!
You may be sporting the eyelashes of a seventeen year old (they wish) but those luxuriant lashes are distracting you from noticing a worrisome and sinister loss of volume in your upper eyelid folds, thinning of your eyelids, causing discoloration due to loss of ground substance in the eyelids, and even permanently changing iris color. These changes can be seen after as little as 3 months of using lash growth products that contain prostaglandin analogues.
Never heard of this before? You are not alone. The information is in the package insert for Lastisse®, Allergan’s blockbuster lash growth product. The FDA requires Allergan to disclose this information in the package insert and even state this in the fine print of their ads. But how many people actually read the fine print? Your prescribing doctor probably has never seen the package insert. Perhaps you never even talked to a doctor about Latisse if you purchased your lash growth product online. Prescribing doctors are more likely to influenced by a drug company detail person who calls on their office. The detail person or drug rep may only share with them company sponsored papers. In the case of Latisse®, these studies are designed to overlook some of the most common and serious side effects of these lash growth products. The effect is to undermine the FDA package insert warning that are there to protect you.
The Allergan Latisse® studies exclusively use pictures of closed eyelids to measure lash growth. These pictures do not record the loss of the upper eyelid volume due to fat atrophy that is only seen in pictures of the eyes open. The Allergan studies use a very insensitive assessment of iris color. The most accurate assessment comes from directly comparing iris color photographs at high magnification before and after treatment. Allergan did not use this method in any of their studies. One of the early papers on Latisse actually states that the authors had collected other data like the pictures of the eyes open before and after treatment but choose to ignore it. That is called a “post hoc” or after the fact analysis. The choice meant they had very little to observe about orbital atrophy or iris color change compared to much more detailed and less biased glaucoma studies of the bimatoprost, the active agent in Latisse®.
Unfortunately, no independent body oversees these types of papers, which are the work of drug company employees, public relation firms, and paid physician consultants and contractors. The articles are published in for profit online journals. However, it takes truly deep knowledge of the literature to really understand how a paper may overlook certain observations. When is a study design an accident and when is it a work intended to mislead? Some of these physician contractors, who conduct this work and write these papers, have been paid well over a million dollars for their work. Is that enough money to look the other way when it comes to potentially serious complications? You will have to draw your own conclusions about this.
Of course, there was that very negative story about Latisse® that appeared in the New York Times many years ago (https://nyti.ms/2kGU). Bloggers have also shared their negative experiences with Lastisse. However, with all the Internet hype focused on selling Latisse and other lash growth products, the authors of these negative reports have sounded like shrill Casandras and Internet fruitloops. It is easy for a blogger to be drowned out by hundreds of millions of dollars worth of high-powered marketing.
Here is what we do know about the prostaglandin lash growth products. Latisse® (Allergan Inc, Dublin, Ireland) and the generic Bimatoprost Ophthalmic Solution 0.03% (Sandoz, Holzkirchen, Germany) are based on a side effect of prostaglandin glaucoma drops. Early studies of this new category of glaucoma medication showed that they powerfully reduced intraocular pressure but also had some curious side effects. One of which was that exposure to these compounds for as little as 2 to 15 days induced dramatic growth of both eyelashes and under developed hairs that are found around the eyelid (lanugo hairs). If you are treating glaucoma, this is a side effect but if you are a drug company looking for new markets, this side effect looked like a new treatment to help patients with sparse eyelash hairs. These observations became the basis for Latisse®, which was approved by the FDA in 2008.
However, eyelash growth was not the only side effect that was observed by glaucoma investigators studying this new class of lash grow products. Eyelid and conjunctival redness and irritation are probably the most common and widely observed side effects. These effects are seen in 50 to 60% of individuals using bimatoprost. In carefully performed studies comparing pre-treatment and post-treatment iris color images, increased iris pigmentation is seen in up to 70% of eyes. The change in iris color is thought to be permanent but in most cases, the change is subtle.
In 2004, two optometrists, Peplinski and Smith published a paper reporting on three of their patient who were using bimatoprost for glaucoma and who developed deepening of the upper eyelid sulcus. These individuals were only using the drop in one eye, which highlighted the contrast caused by the loss of volume in the upper eyelid fold. In one case, the effect was seen after just six weeks of treatment. The authors called this prostaglandin-associated periorbitopathy. While this was the first report, numerous authors have now documented and further described this entity. The loss of volume in the upper orbit is seen with all of the prostaglandin glaucoma drops but the effect is greatest for bimatoprost, the medication in Latisse. Studies suggest that as many as 50 to 60% of individual using prostaglandin glaucoma drops will develop deepening of the upper eyelid sulcus. Studies suggest that stopping treatment reverses the effects in some but not in all cases. This may be related to how long the eyelid tissues are exposed the medication.
Loss of volume is not the only change that is reported. Investigators Custer and Kent studied patient referred for assessment for prostaglandin-associated periorbitopathy. The found that all most all of the patients referred had thinning of the eyelid and other changes consistent with fibrosis of the eyelids. Discontinuation of treatment only resulted in partial resolution of these finding. This of course is what was found for individuals using bimatoprost for glaucoma. The average age for people being treated for glaucoma is about 70 years of age. Do they look older as a result of using prostaglandin glaucoma drops? Absolutely, but the trade off is that they look older but the prostaglandin drops are saving vision.
Does one see the same types of complications when using Latisse® for lash growth? If you look at the warnings that the FDA requires Allergan to put in the package insert for Latisse®, the answer is a resounding yes! In that fine print, the FDA has required Allergan to warn consumers that Latisse® can cause permanent changes in iris pigmentation and loss of orbital volume. This message has been carefully undermined by Allergan. The post FDA approval literature regarding the safety of bimatoprost ophthalmic solution 0.03% for lash grow is singularly dominated by research funded and performed by Allergan and its contractors. These studies paint a very different picture about the safety of Latisse®. As already noted, the Allergan studies use weak methods for detecting compications.
Allergan studies do not tell us precisely how much Latisse is transferred from the lash brush to the eyelid margin. Instead, they offer a photograph that purportedly demonstrates what happens when a drop of green dye is instilled in the eye versus applying a drop of green dye with a Latisse eyelid brush. The side with the drop instilled in the eye in this photo is literally covered with green dye, which coats the lashes, the tears, and the eyelid. In contrast the side claimed to be brushed with green dye loaded onto the type of brush that is supplied with Latisse shows a faint bit of green on the eyelid just above the eyelashes. This photograph was published in two Allergan sponsored papers on Latisse and the past president of Allergan described the photograph in news articles. The message from Allergan, based on this one photograph, is that only 5% of the dose that is applied to the eye with the glaucoma drop is applied to the eyelid margin with the brush supplied with Latisse. They argued that this is why the complications seen in the glaucoma literature with bimatoprost ophthalmic solution are not seen with Latisse® for lash growth.
It is likely that many physicians actually believe this piece of marketing rather than the product warning required by the FDA in the package insert. As comforting as it might be to believe this statement, it is very unlikely to be accurate. A photograph is not a scientific study. If Allergan wanted to be accurate here, they would weigh Latisse brushs before and after the application of Latisse to the eyelid. The fact that this information has not been released would suggests that it not support the 5% assertion. Indeed Allergan videos that show consumers how to apply Latisse to the eyelid with the brush suggest much more than 5% of the drop makes it on the eyelid. It is hard to tell from the video if 90%, 80% or 70% of the drop is actually transferred (see video). Whatever it is, it is much more than 5%. The assertion of these Allergan studies do not wash. It is much more likely that the reason that the Allergan studies do not find more complications is that the Allergan studies were designed to not discover these complications. Latisse studies exclusively use the so-called superior view of the closed eye for measuring lash growth. By not using before and after images of the eyes open no information can be discerned about the hollowing and atrophy of the eyelid tissue caused by Latisse®. By not using magnified before and after photos of the iris, there is very little likelihood of documenting iris color changes. In the glaucoma studies where these methods of documentation were used, up to 60% of bimatoprost users were found to have iris color pigmentation changes and deepening of the upper eyelid sulcus.
The deepening of the upper eyelid sulcus, lid thinning and fibrosis are unlikely to fully resolve with the discontinuation of Latisse. The effect is the permament premature aging of the eyelids. Is this worth it for thicker, darker, longer eye lashes? The answer has to be no. It is one thing to have drug induced ageing of the eyelids to prevent blindness from glaucoma. The benefits of saving vision far out weight the harm caused by premature aging. Are darker, thicker and longer eyelashes worth the premature aging of the eyelids? I do not think so. What do you think? Most people reading this are will be learning of these effect for the first time.
What about other eyelash products out in the market? Do the lash serums that show up in the stores present a similar risk? The government of Sweden has a monitoring program for these new lash serums. What they have found is that if the product actually grows lashes, it contained either a known prostaglandin glaucoma medication or one of the unapproved prostaglandin analogues. The bottom line is that these products all share the same complication profile. Prostaglandin analogues prematurely age the eyelids and permanently increase iris pigmentation. Buyer beware!
Consumer Important Safety Information
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes.
Important Safety Information
Do not use LATISSE® if you are allergic to one of its ingredients. If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. May cause brown darkening of the colored part of the eye which is likely permanent. LATISSE® may cause eyelid skin darkening which may be reversible. Only apply at base of upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes. If discontinued, lashes gradually return to previous appearance.
These are not all the possible side effects of LATISSE®. For more information, please talk to your doctor.
Please see LATISSE® full Product Information.