The Food and Drug Administration said Wednesday that it has sent a warning letter to Irvine-based Allergan Inc. about the Web site for its Latisse eyelash-growing drug.
The FDA said in its letter that the Web site suggests that Latisse, which Allergan introduced earlier this year, was safer than has been proven.
Regulators said that Latisse’s Web site and other promotional materials from Allergan were “misleading” because they omitted and minimized risks associated by Latisse, including changes in eye color and redness.
The FDA said it asked Allergan to immediately stop using the materials.
Allergan said that it’s working closely with the FDA to address the concerns, and a spokeswoman told Reuters that it’s no longer using an exhibit that described the evolution of lash enhancers, which drew regulators’ objections.
Latisse was approved for lengthening and thickening eyelashes in late 2008. The drug, which is endorsed by actress Brooke Shields in television commercials, is off to a solid start.
Allergan has projected that full-year Latisse sales will come in at $60 million in 2009 and said sales could eventually reach $500 million at peak.
Latisse came about after Allergan researchers found that bimatoprost, the active ingredient in its Lumigan glaucoma drug, grew lashes as a side effect.
