Terra Sigillata

Lashing out at Latisse®

I am running out of eyelash puns having written at least six posts since the summer of 2007 on a class of anti-glaucoma drugs that have been harnessed for their cosmetic side effect: promotion of eyelash growth. Bimatoprost (Lumigan®) and latanoprost (Xalatan®) are members of the prostamide class of drugs that can manage some forms of glaucoma by reducing intraocular pressure. When administered as eye drops, the drugs mimic the effect of endogenous prostaglandin PGF2α, acting as a local hypotensive to promote outflow of aqueous humor from the eye through the trabecular meshwork.

Invoking the tagline of one of my pharmacology profs, “today’s side effects are tomorrow’s therapy.” From the prescribing information for Lumigan® brand of bimatoprost (PDF):

LumiganĀ® may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.


i-1ec7f1af7a9fc857a73f564436afcfd9-Latisse250px.jpg

This effect was picked up first by cosmeceutical companies that began marketing chemical relatives of the prescription drugs as eyelash rejuvenators, only to have action brought against them by the US FDA. FDA does not recognize “cosmeceuticals” as a product class but stepped in because cosmetics companies were selling unapproved drugs.

About the same time, Allergan, manufacturer of the Lumigan brand of bimatoprost, sought approval for a product called Latisse, comprised of the same compound but applied to the eyelash line with a sterile brush rather than into the eyes as ophthalmic drops. FDA regulates this latter product because it was approved to treat hypotrichosis, the lack or paucity of eyelashes. Nevertheless, it is clearly being sold as a cosmetic judging from their website’s “Eye Candy” tab and video advertisement with Brooke Shields.

I can’t watch the time-lapse segment of the advert without thinking of a Saturday Night Live parody where the lashes would continue growing incessantly.

Today, several medium-circulation national newspapers picked up on a 27 October blogpost by Julie Deardorff (Julie’s Health Club) of the Chicago Tribune where she pointed out that Allergan has had some difficulty with FDA regarding their incomplete disclosure of potential side effects in commercial advertising materials.

In FDA’s ongoing surveillance of promotional claims for approved drugs, Allergan received a warning letter (PDF here) from the agency dated 10 Sept 2009 citing several offenses. It’s worth glancing over the seven-page letter from FDA if for nothing else than to see just how closely drug advertising is monitored by their Division of Drug Marketing, Advertising, and Communications (DDMAC). It appears that the company was judged to have underemphasized the risks of the drug in changing iris color, causing darkening of the eyelash line, or in growing hair on other parts of the skin where the drug might be accidentally applied.

The company does appear to have been somewhat responsive to the FDA letter. The following text is now displayed prominently at the bottom of the Latisse.com:
Important Safety Information

If you are using prescription products for lowering eye pressure or have a history of eye pressure problems, only use LATISSE® under close doctor supervision. May cause eyelid skin darkening which may be reversible, and there is potential for increased brown iris pigmentation which is likely to be permanent. There is a potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. If you develop or experience any eye problems or have eye surgery, consult your doctor immediately about continued use of LATISSE®. The most common side effects after using LATISSE® solution are an itching sensation in the eyes and/or eye redness.

Please see Full Prescribing Information link below.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

There is also a menu tab at the top of the page, second from the left, entitled “About Safety,” just a few more positions of prominence from “Eye Candy.”

However, this historical timeline cited in the violation letter, “Evolution of Lash Enhancers,” doesn’t talk about the disorder of hypotrichosis. Rather, it appears to document the development of cosmetics, not medicinal products. So, I’m still not exactly clear on how a drug can be approved for a medical condition (hypotrichosis) yet still advertised for what is clearly a cosmetic purpose for people without eyelash problems.

For your easy reference, here are all Terra Sigillata posts by Abel Pharmboy on eyelash cosmeceuticals:

27 July 2007: For thicker, fuller lashes…a glaucoma treatment
20 November 2007: Forty lashes for a cosmeceutical company
7 January 2008: Jan Marini finally bats an eye at FDA, Allergan
4 June 2008: Today’s side effects are tomorrow’s therapy
28 December 2008: Latisse™: eyelashes are the new handbag
03 November 2009: Lashing out at Latisse®
04 November 2009: Latisse®: Tell me more about my eyes

Comments

  1. #1 ERV
    November 3, 2009

    OMG this commercial makes me want to throw up!

    Its worse than mucinex or even the toenail fungus troll one.

    Mostly cause Mucinex and Lamisil dont permanently change your eye color. WTF, Latisse!?!?!?

  2. #2 Texas Reader
    November 3, 2009

    I considered getting a scrip for this from my dermatologist until I found out it would cost me over $80 a month.

  3. #3 Julie Deardorff
    November 4, 2009

    Great post, Abel Pharmboy. Wish I’d seen your previous ones before writing mine. But I’ll link to it right now. I also need a source on dietary supplements…if you can help just email.

  4. #4 becca
    November 4, 2009

    “I’m still not exactly clear on how a drug can be approved for a medical condition (hypotrichosis) yet still advertised for what is clearly a cosmetic purpose for people without eyelash problems.”
    Is it philosophically that different from ED drug marketing? Or does male sex life intrinsically strike you as a more valid medical concern than female appearance?

  5. #5 Abel Pharmboy
    November 4, 2009

    Touché, becca. I make no judgment on the relative validity of ED vs. hypotrichosis. For the record, I find all ED drug commercials orders of magnitude more unpleasant than the Brooke Shields advert.

    My concern intended in that quote is more with the FDA approval of a drug for a medical condition but which is now heavily marketed for a cosmetic purpose – something I would call a off-label indication. Other drug companies are spanked heavily by the FDA for any off-label advertising, although physicians are free to prescribe drugs for anything they wish (but pharmacy benefits mgmt companies rarely reimburse for off-label indications).

    For example, I suspect that Latisse is not covered by insurance but the ophthalmic preparation of bimatoprost used for glaucoma (Lumigan) is.

  6. #6 John McKay
    November 4, 2009

    How soon before they start marketing it to men as a baldness treatment?

  7. #7 becca
    November 6, 2009

    Abel- I’m glad to see your latest post. Yeah, that ED ad looks not just frivolous but also pernicious. It almost makes this look reasonable. Except that it’s silly. The off label advertising restriction obviously makes sense, given this kind of problem. At the same time, I know I appreciate it when my doctor is quite sure an existing compound available in generic works fine for some off-label purpose instead of prescribing a similar compound that is only available under patent for that purpose. It’d behoove pharmaceutical reimbursement programs to figure out when it saves them money to do it that way, but it’s a messy situation.

  8. #8 Lilash Girl
    November 7, 2009

    Did you try Lilash eyelashes growth products? They offer 90 day money back so it’s risk free

  9. #9 TRUTHFUL
    February 5, 2010

    My iris color darkened from using this product. I applied the correct amount to my EYELIDS and today I have yellow brown eyes. Bye bye beautiful green eyes. Thanks Latisse for making me so beautiful! However, no clinical test studies have shown a change in iris color. Hmmm, very interesting. Other women need to come out and tell their stories because I know that you are out there.

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