Latisse Potentially Unsafe

FDA Warns the Manufacturer of Popular Eyelash Growth Treatment

Oct 12, 2009 Joanna Castle Miller

The FDA-approved drug Latisse claims to regrow eyelashes and treat eyelash loss, but its marketing has downplayed its side effects and is the subject of federal scrutiny.

Latisse, the first prescription drug FDA-approved to combat eyelash hair loss, is currently under fire from the same organization that approved it in December of 2008.

The drug was placed on the market and made available for prescription early in 2009. Since then Allergan, Inc, the manufacturers of Latisse, have launched an extensive marketing campaign on television and online. It is this campaign that has the FDA concerned, as the federal organization claims that Allergan's marketing has been misleading about the serious potential side effects of the drug.

The Side Effects of Latisse Downplayed

In September of 2009, the FDA issued a warning to Allergan stating that the drug's marketing was misleading because the ads "omit and minimize risks associated with Latisse." Side effects include:

  • Iris pigmentation, or an increased brown coloring of the eye that is likely to be permanent
  • Lid pigmentation, or a darkening on the skin of the eyelid that is also likely to be permanent
  • Hair growth outside of the treatment area, including the cheeks, forehead or any other skin surface that Latisse touches
  • Intraocular inflammation, characterized by redness and irritation, blurred vision, eye pain and sensitivity to light
  • Bacterial keratitis, or a serious infection of the cornea that can be caused by misuse of the product
  • Unexpected eyelash changes, which refers to the possibility that one of the sets of eyelashes might grow noticeably differently than the other set

In addition, eyelashes will return to their original appearance after discontinuation of the product, so for long-term results, usage of the product must be permanent.

The FDA warning asserts that Allergan has downplayed the seriousness of the drug's possible consequences and also has failed to present the risk information associated with Latisse in a prominent and readable manner, both on television and on the drug's website. In particular, the administration points out a complete omission of information regarding the unintended hair growth side effect, in which hair can grow accidentally anywhere on the skin that the product touches.

Advertising Latisse as a Cosmetic Product Rather Than a Medical Treatment

Latisse was designed to treat hypotrichosis, a condition in which hair growth does not occur or is extremely inadequate. Hypotrichosis is also used at times to describe hair loss resulting from chemotherapy use or other medical procedures.

But according to the FDA's warning, the product has been advertised less as a cure for a legitimate defect and more as a cosmetic wonder. Just as any prescription drug, Latisse carries with it the potential of serious side effects. While patients suffering from hypotrichosis might find the side effects to be worth the results, women with no serious condition might benefit more from an alternative solution like mascara instead of risking the development of Latisse's side effects, some of which can be permanent.

The FDA points out that Latisse's website also has omitted important safety information regarding use of the drug, including how dangerous it can be to use Latisse with contact lenses in place, and the risk of infection if the product is used incorrectly.

What Women Using Latisse Can Do

Women considering Latisse should research thoroughly the potential side effects of the product before beginning treatment and determine if the benefits are worth the risks. Application of Latisse should only be done using extreme caution and after consultation with a physician about how to apply the drug safely.

All women adversely affected by the product should discontinue use immediately and seek medical attention to count out any serious or permanent side effects. In addition, any woman currently using the product should pay careful attention to her eyes and face and report any unexpected changes in appearance or comfort to her physician.

As Latisse has been the subject of FDA scrutiny, particularly for misrepresentation of its side effects, women who have been hurt by the product can also seek legal reparations. Any woman on Latisse who has experienced permanant damage or discoloration is entitled to speak to an attorney and become aware of her rights. But currently the product has not been used widely enough to spark a class action lawsuit, and thus most attorneys are not yet prepared to defend Latisse patients in court.

The drug requires long-term application, as its benefits do not last after patients stop using Latisse. Women who have not noticed any side effects in the first few months might still develop symptoms over time. Because of the health, cosmetic and legal uncertainties involved in using Latisse, it is important that all women currently on the product be aware of the drug's risks and strongly consider an alternative eyelash enhancement product such as mascara or false eyelashes before any side effects occur.

The copyright of the article Latisse Potentially Unsafe in Women’s Health is owned by Joanna Castle Miller. Permission to republish Latisse Potentially Unsafe in print or online must be granted by the author in writing.
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