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FDA Demands New Warnings for Latisse

By September 19, 2009

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The U.S. Food and Drug Administration has issued a letter to Allergan (the makers of Latisse) stating that Allergan is in violation of the laws governing Latisse's approval for the lengthening, thickening, and darkening of lashes. In the letter, the FDA takes issue with the minimization and omission of risk information in the company's marketing materials and on the Latisse website.

Specifically, the issue is with Allergan's failure to mention the risk of hair growth outside of the intended margins, and of Allergan's failure to tell prospective users that they should not apply Laitsse to the lower lash line. The FDA's letter to Allergan also states their finding that the company has minimized the risk of increased permanent brown iris pigmentation with the use of Latisse.

In addition, the FDA has ruled that the FAQs page of the Latisse website is misleading when it comes to allergic reactions and possible infections which can be caused  by contamination of the Latisse applicator.

Read the full text of the FDA's letter to Allergan about Latisse.

On the flipside, patient satisfaction so far appears to be high with Latisse, according to reviews and ratings posted on RealSelf.com.

Have you used Latisse? Do you feel the risks were represented accurately and prominently enough for you to make an informed decision about using it? Please share your experience.


Comments
September 20, 2009 at 12:37 am
(1) Harry says:

Latisse (bimatoprost) is a serious glaucoma medication. The risks minimized including that of eye infection which can easily lead to blindness. Indeed, it is clear that these promo materials went out of their way to minimize that possibility.

This is a big deal.

September 30, 2009 at 3:19 pm
(2) Ivy says:

I think there are two different issues here. If the marketing materials totally omitted specific information about serious side effects (such as blindness), that’s lying by omission, and certainly a major–and terrifying problem. If that’s the case, Latisse should be taken off the market. However, I’ve used Latisse since May, and the package materials, and the box, plainly state that the product should only be used along the upper eyelid margin (and NOT the lower eyelid) and that use of Latisse IN the eye can lead to possibly permanent brown pigmentation there. Caveats about possible skin irritation also abound. I should add that it works incredibly well–my lashes are definitely noticeably longer and thicker.

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