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latisse, eyelash enhancer, eyelash fertilizer

FDA Approves “Eyelash Fertilizer”

December 08, 2008 01:30 PM
by Isabel Cowles
The FDA has approved the use of glaucoma drug Lumigan as an eyelash enhancer; it will be marketed under the name “Latisse.”

Lumigan Labeled Latisse With FDA Approval

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The Food and Drug Administration (FDA) has approved the cosmetic use of an eye disease drug, allowing it to be sold as an eyelash enhancer.

Currently called Lumigan, the drug is produced by Allergan, the same pharmaceutical company responsible for Botox.

Lumigan was originally developed to treat glaucoma; however, researchers at Allergan discovered that patients who used the drug grew thicker, longer and darker eyelashes as a result. Allergan plans to call the product “Latisse” when marketing it cosmetically and expects the repurposed drug to generate about a half a billion dollars annually, the Associated Press reports.

An Allergan-conducted review tested 278 patients over the course of 4 months, intending to confirm that the drug increased thickness, length and darkness of lashes. A review of the study by the FDA showed that participants using the drug saw significant cosmetic changes, as compared to patients who received a placebo.

Last Wednesday, the FDA posted a review of the active ingredient in Lumigan on its Web site, preceding an independent review of the drug by medical experts, who voted on Friday to approve the drug for cosmetic purposes.

The panel of eye and skin specialists voted unanimously that the drug’s benefits outweighed its risks, according to WPVI, ABC’s Philadelphia affiliate. However, the panel also voted 5–3 that Allergan should be required to continue studies on certain patient groups.

Allergan says it will sell Latisse under a “risk management plan” meant to encourage doctors to explain and monitor possible side effects. The drug can lower intraocular eye pressure (which is why it’s used as a glaucoma drug) and may cause skin darkening in some users.  

However, some doctors believe these safeguards may be not be sufficient to prevent potential abuse of the drug. Dr. Marijean Miller, ophthalmologist with the Children’s National Medical Center in Washington said, “I’m worried about off-label, nonsupervised use of this medication, and I’m concerned teenagers might use it three or four times a day instead of once.”

Background: Off-label drug use not sufficiently regulated

Approving Latisse may be one way for the FDA to avoid the sort of criticism it received this summer, when the Government Accountability Office condemned the FDA’s lax enforcement of laws restricting the marketing of off-label drugs.

According to the Associated Press, Iowa Sen. Charles Grassley said in July that the FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law. As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

Opinion and Analysis: Are there flaws in the FDA approval process?

Citing the report by Senator Grassley and the Government Accountability Office, the Web site A Drug Recall looked at some of the typical criticisms made against the FDA and its process of approving drugs; they include “excessive regulations,” “political biases,” and a “lack of mandatory adverse event reporting.”

In 2005, after the controversial FDA-approved drug Vioxx was taken off the market for causing extreme adverse side effects in patients, AllBusiness.com examined the agency’s approval process, noting that since the early 1990s, the FDA has been “alternately criticized as either a bureaucratic obstacle to industry, or the lapdog of industry—too slow in getting desperately needed drugs to the public, or too fast in rushing dangerous drugs onto pharmacy shelves.”

Reference: FDA application review process; Lumigan eyelash study

Related Topic: Beauty on the Web

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