News & Politics

New Cosmetic Has Dangerous Side-Effects -- Why Do People Use It?

Despite the Maybelline close-ups, Allergan's new drug Lattise is not mascara, but a glaucoma drug repurposed as an eyelash grower. And its side-effects are frightening.

Not enough lashes? GROW THEM! exhorts a billboard with a life-size likeness of Brooke Shields at a Chicago shopping mall. Grow longer, fuller, darker lashes says a TV ad for the same product showing Brooke enchanting everyone at a party with new flutter appeal. 

But despite the Maybelline close-ups, lash applicator and vanity sell, Allergan's new drug, Lattise, is not mascara -- but a glaucoma drug repurposed as an eyelash grower. 

Like Viagra, intended as a blood pressure medication until a certain side effect surfaced, Retin-A, which treated acne before wrinkles, and Botox, first used for eye spasms, the ingredient in Allergan's Lumigan, bimatoprost, turned out to stimulate eyelash growth. Older glaucoma drugs like latanoprost and travoprost -- called prostaglandin analogs because they bind to prostaglandins or lipids -- also stimulated lash growth but not as much. 

A lash stimulator also fit well into Allergan's portfolio. The Irvine, CA-based eyecare company launched Botox in 2002 and now markets the facial filler Juvederm, breast aesthetics, and balloon and banding devices for obesity "interventions." 

Because Lattise was approved by the FDA for hypotrichosis -- inadequate hair growth -- many expected its marketing campaign to "sell" hypotrichosis like restless legs syndrome or other diseases du jour when it began last year.  Others thought its natural audience would be the Botox and Restasis (Allergan's dry-eye drug) set: aging boomers with thinning lashes, or people who had undergone chemotherapy.

Wrong. Lattise was pitched as a cosmetic must-have like lip gloss, with actress Brooke Shields serving as its "compensated spokesperson and actual user," and teens and 20-somethings became its biggest fans. In fact, over-the-counter products with bimatoprost called MassiveLash, DermaLash, Luxette, Age Intervention and MD Lash Factor actually preceded Lattise to market -- and their manufacturers were sued by Allergan in 2007 for patent infringement. At least 10 remain on the market, their ingredients unclear, and users compare them to Lattise on beauty Web sites. 

At first blush, Lattise is reminiscent of permanent eyeliner and other permanent makeup, which lost popularity after the FDA warned it could cause disfiguring granulomas in 2004. In fact, saving money on daily mascara is used as a defense of Lattise's $120 a month cost, rarely covered by insurance. 

But it also shares the risk features of LASIK eye surgery and the "addiction" features of Botox. "If discontinued, lashes will gradually return to their previous appearance" warns a disclaimer in the TV ad. Translation: if you like the effects, you've got a monkey on your back from now on. Why else do dope dealers say "first taste free"? 

Lattise works. Everyone from Shields, to makeup-nistas to the doctors who reached their career lows rating "eyelash length, fullness and darkness" for Allergan's FDA submission agree that it works. 

It's what else it does that give Lattise its drawbacks. 

"My eyelids have become darker," posts one Lattise user on a Consumer Reports blog. "I have also had the problem of hairs growing in the corner of my eye, which I just pluck out with little pain, and one eyelash that grows in an errant way." 

"My lashes all of a sudden grew in a burst, got very spindly/spidery, and then many shed at the same time," posts another on essentialdayspa.com

"My classmate…sprouted fuzzes on her cheeks area right below her eyes," says another poster on soompi.com. "It was honestly pretty nasty, lashes were not worth it because I don't know what she's going to do about her cheeks." 

"My eyes changed from blue green to dark hazel and are now becoming brown," writes a fourth on bellasugar.com. "After a very short period of time I stopped using it and my eyes darkened for months after discontinuation. This product does change eyes to brown and I don't care what the clinical trials say." 

It is not the users' imaginations. According to patient information, Lattise "may cause darkening of the eyelid skin which may be reversible [nee irreversible]... increased brown pigmentation of the colored part of the eye which is likely to be permanent…[and] hair growth to occur in other areas of your skin that LATTISE frequently touches." 

Wait. There's more. "It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes," says the patient information. Elsewhere "periorbital fat atrophy" -- a hollowed eye look from deepened upper eyelid sulci and reduced lower eyelid fullness that screams for a cosmetic fix itself -- is attributed to Latisse. See you at the gala! 

Lattise users also risk eye redness and irritation, inflammation called uveitis, macular edema, cataract, reduced intraocular pressure -- the action that makes it a glaucoma drug -- and vision problems. Contact lenses and the applicator can become contaminated and prostaglandin analogs can reactivate herpes simplex keratitis. 

But it's Lattise's iridial pigmentation -- darkening of the iris -- that is the most ominous side effect: like long-term lash stimulation itself, the long-term effects of iridial pigmentation "are not known" says the prescribing information. ("Until we discover them on you," they might have added.) 

A 2001 study in Current Opinion in Ophthalmology says some patients with the condition "have an apparent thickening of the anterior border zone," and a 2001 paper in Investigative Opthalmology & Visual Science says "The end point of the increase in iridial pigmentation in affected patients is not known." Not too comforting when the pigment granules that are altered are known to be involved in the routing of optic nerves, protection from oxidative stress and protein degradation! 

Using New York-based Grey Advertising and Chandler Chicco Agency for advertising and public relations, Allergan made $79 million from Lattise the first year. It has "refreshed" its spokesperson image and replaced Shields with actress Claire Danes and predicts $140 million in 2010. 

But there are also questions. If Allergan didn't know about the lash stimulating side effect until it was discovered in its glaucoma drug trials -- hello? -- and still doesn't know what causes it, what else doesn't Allergan know about the drug? After all, the bisphosphonate bone drugs caused bone growth too -- until they caused fractures and jaw bone death after people used them for a while. And 10 years ago, Vioxx, Baycol, Avandia and Plavix were the top-selling drugs. Are Lattise users guinea pigs? 

What will be the effects of discontinuing Lattise over time, a factor not commonly observed in glaucoma patients and disregarded to speed Lattise to market? 

Some predict Lattise will be repurposed as a baldness treatment that could dwarf the $130 million Allergan made from Botox last year. Other predict an obesity drug due to Lattise's fat-burning potential and with a lot of "product" necessary to cover thighs or saddle bags. 

But others condemn Lattise as an example of disease and vanity mongering at its worst. 

"This product campaign is just evil," writes an anonymous poster on Cafepharma.com, a site for drug salespeople. A major pharmaceutical company has "developed a prescription drug for people who are so upset by the paucity and/or hoariness of their eyelashes that they feel they need a DRUG to help them remedy the situation. And then I thought about my own eyelashes, which are fairly pale, and wondered whether I ought to rush myself to the nearest hospital." 

"Is it really worth risking your health by using a new drug near eyes when a wand of mascara can give one some pretty stunning eyelashes without all the risk?" asks columnist Julia Bodeeb. Doctors "are healers not beauty mavens." 

Still, many makeup lovers find Lattise, well, awesome, and think it's getting a bad rap. 

"I don't know why people are so scared to have some brown in their eyes. Are brown eyes that bad?" one woman asked on a Consumer Reports blog. 

And in answer to "Why would you subject your health and SIGHT on something that you know little about?" on wakeupinyourmakeup.com, another woman wrote, "Because it's my health and sight and not yours... and because I can."

Martha Rosenberg frequently writes about the impact of the pharmaceutical, food and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune and other outlets.