FDA Says Eyelash Thickener Website MisleadingSep 17, 2009 | Parker Waichman LLP
The newly released, prescription eyelash thickener marketed by Allergan is not without its problems. The U.S. Food and Drug Administration (FDA) has deemed marketing materials touting Latisse as “misleading.”
The FDA asked Allergan to immediately stop using the materials, reported Reuters.
Latisse runs about $120 per month for the once-daily treatment, said the Reading Eagle. The medication is applied with a brush, similar to applying nail polish, at the base of the lashes, on the lash line.
In its September 10 letter to Allergan, the FDA stated that Latisse’s ads "are misleading because they omit and minimize risks associated with Latisse," quoted Reuters. The agency told Allergan that its Website for Latisse does not appropriately detail some of the drug’s side effects, such as redness and eye color changes, reported Reuters.
The FDA also said that some of the pages on the Latisse’s consumer Website neglect to mention that there is a risk of bacterial infection if either the medication or its applicator are contaminated and that eye redness and itching were downplayed, said Reuters. It seems that the Allergan Website suggested that the itching and redness “were not associated with allergic reactions related to the treatment,” said Reuters, citing the agency.
Dow Jones explained that the eye infection—bacterial keratitis—can cause blindness.
Allergan's website also "misleadingly suggests that only 'similar' medications have been associated with the risk of increased iris pigmentation," which causes eye color to become more brown, the agency said. Some of Allergan’s advertising describing lash enhancers’ progress has been stopped, said Reuters. That particular set of materials was pf particular concern to the agency, added Reuters.
Dow Jones wrote that, Latisse, which received approval in December 2008, is prescribed to increase eyelash length, thickness, and pigment; Latisse was originally developed by Allergan for the treatment of glaucoma. In addition to the other adverse reactions sited and not mentioned on the Website, said Dow Jones, Latisse can also prompt hair growth in areas other than the lash line if it comes in ongoing skin contact elsewhere.
KJRH reported that in drug trials for the glaucoma drug Lumigan, researchers noted that eyelashes grew thicker. Allergan then repackaged Lumigan, calling it Latisse, and received FDA approval. In addition to having to reapply the expensive cosmetic fix in order to maintain the lashes and that the medication can darken eye color—for instance, turning blue eyes brown—use of Latisse could mask the potentially blinding eye disease, glaucoma, noted KJRH.
The FDA gave the drug maker until September 24—later this month—to respond to its request to correct its Latisse materials, said Dow Jones.
According to Dow Jones and Reuters, Allergan shares traded up at over $58 an increase of between 2.6 and three-percent on the New York Stock Exchange. Said Reuters, Allergan has forecast its peak sales for the lash lengthener at over $500 million annually. Allergan is also known for its popular wrinkle injection, Botox, which has also been making headlines for number of serious side effects, including some reported fatalities.