FDA warns maker of Latisse about misleading claims

We’ve blogged about the new eyelash enhancement drug Latisse several times before. And we’ve talked about how the drug has some side effects that are rather serious for a cosmetic product, and that Allergan’s promotional materials tend to downplay such risks. Now the Food and Drug Administration has sent a warning letter to Allergan, saying that many claims on its website are misleading and, in fact, unlawful.

You can read the whole letter for yourself, but here some highlights.
 
Latisse’s Website says:
In the “Is Latisse safe?” section of the drug’s website: “The FDA reviewed clinical study results to verify the identity, potency, purity and stability of the ingredients, and demonstrated that the product is safe and effective for its intended use if used as prescribed.”

The FDA says:
This description is misleading and it fails to mention that Latisse may have side effects, or mention any of those side effects. It also implies, according to the FDA, that Latisse is “especially safe because the FDA has verified the identity, potency, purity, and stability of the ingredients.”

Latisse’s Website says:
The website also answers the question, “Why do the directions say to only apply Latisse solution to the base of the upper eyelashes?” by saying: "A clinical trial of Latisse was conducted on patients who applied the product to the base of their upper lashes only. Applied nightly, the transfer of Latisse solution from the upper to lower eyelid may occur naturally because the eyelids are closed and the eyelashes touch each other."

The FDA says:
The answer fails to warn users of the real reason why Latisse should not be applied to the lower eyelid: If Latisse comes in continued contact with skin outside the treatment area, it could lead to excess, unwanted hair growth.

Latisse’s Website says:
The Latisse website claimed that “increased brown iris pigmentation has occurred when similar medications were instilled directly into the eye to treat elevated intraocular pressure/glaucoma.”

The FDA says:
In fact, the “similar” medication was actually the same medication. Both Latisse and Lumigan, a glaucoma drug also from Allergan, are actually bimatoprost ophthalmic solution. Though Latisse is applied differently, brown iris pigmentation has been reported from use of the drug. The FDA says, “by omitting this material information and suggesting this side effect has only occurred with ‘similar’ medications, this claim minimizes the risk of increased iris pigmentation.”

Latisse’s website says:
The site repeatedly mentions that the eye redness and itching that can accompany the use of Latisse are “not allergic reactions.”

The FDA says:
That’s misleading. In fact, allergic conjunctivitis is an adverse reaction reported with the use of the active ingredient, bimatoprost ophthalmic solution. Further, these symptoms are usually resolved only after discontinuing treatment with the drug. The FDA was particularly concerned about these claims, according to the letter, “because patients are highly unlikely to be able to differentiate between eye redness associated with conjunctival hyperemia, allergic reaction, or inflammation without the advice of a healthcare provider.”

The letter requests that Allergan cease from disseminating these, and any other misleading claims about Latisse, and noted that the examples in the letter are not an exhaustive list—there could be more. The company has until Sept. 24th to respond. In the meantime, feel free to go to the Latisse.com Website and look for more misleading statements. If you find any, post them in the comments.

—Kevin McCarthy, associate editor

 

Comments

[minx]

i've been using latisse for a little over 6 weeks and i dont see anything wrong about it. so far my eyelashes seem to be twice as long and i dont see any unwanted hairgrowth or brown pigmentation or even eyelid darkening..i love it

[Pat]

As a glaucoma patient, I was taken aback when I first saw an advertisement for Latisse, as it is basically the same medication I take to stave off blindness.

Unless someone truly has no eyelashes (as indicated by the poster who had gone through chemo), I don't understand why anyone would want to use this drug for cosmetic purposes. Sure, it makes your eyelashes grow longer and thicker - in my case, at times my lashes have grown out in all sorts of weird/unnatural directions.

Also, if you are not careful about wiping the excess drops from your face, the drug can cause redness and discoloration in the skin under the eyes -- not what I would consider to be a good tradeoff for having longer lashes.

And unless you already have brown eyes, there is a possibility that your eye color could change over time. There isn't anything wrong with brown eyes, but there is something about having your eye color change that has an effect on your sense of identity. I guess I'm lucky, as my eyes are still green after 4 years on this medication.

I also wonder what instructions are provided to users regarding proper storage of this medication, as temperatures over 77 degrees can cause spoilage problems. I've been advised to store my medication in the refrigerator and to toss the bottle after it has been opened for 6 weeks, to avoid spoilage (and resulting eye infections).

[Gail]

I know this will vary from clinic to clinic. But what is the average cost? Also what is the standard length of use of product?

[Sharon]

I have been using Latisse for about 5 mos. Having lost my eyelashes to Chemo, I an happy to say that I now have lashed long enough for mascara. I have been lashless for almost 5 years. My lashes are not thick, but perhaps when I stop taken cancer drugs, in 2010, they might thicken up. I could not be happier! I have light green eyes and have not seen any change in the color nor have I had any other reactions other than a little darkening on the upper lid which is covered by eye color.

[Percy the Jeep]

To Amy - no, brown eyes are great. But if you have light green eyes as I do (which are relatively rare, I might add), then turning them brown would in fact be a very big deal.

Not sure if this risk is overblown or not - it takes a while apparently for it to happen (and it only happens to some) and it is more common with the stronger eyedrops. I'll need to find out more before I use this product. btw - I want to use it as I have almost no eyelashes.

[flower cardona]

I'VE BEEN USING LATISSE FOR THE PAST MONTH NOW.. I LOVE LATISSE! MY LASHES LOOK BEAUTIFUL! I' VE HAD NO PROBLEMS WITH LATISSE.. I RECOMMEND IT..

[Amy]

I love my Latisse. It is amazing! I look like I have fake eyelashes on every day. Didn't bother me about the iris pigmentation since I have brown eyes already and love them. I don't know why people are so scared to have some brown in their eyes. Are brown eyes that bad?

[David]

Thanks for sharing this information. Watching the commercial immediately set off alarm bells in my mind, and, as a blogger who takes pride in addressing such issues, was happy to find this post (and saddened at its contents).

[Carol Hill]

I have been using Latisse for the past 6 months or so...I love it. I've had no side effects and my eyelashes look great. I've had women ask if they were real. I'm a natural redhead with very pale lashes..well they used to be pale. Now they are long, thick, darker and beautiful! Thank you Dr Klein (my MD) and thank you Latisse.

[Adrianne]

The risk of increasing the brown pigment in the iris is whats stopping me from using his product. Latisse should further explain how many of the patients have increased brown pigment in their iris, and to what extent.

[Yamile]

Brooke Shields has light colored eyes. Have her eyes darkened with the use of Latisse? Did they find iris darkening during Latisse trials?