DDMAC issued a warning letter to Allergan that singled out misleading aspects of Latisse's brand.com site.
According to the letter
, posted on the FDA's website yesterday, the website's FAQs, About Safety and an eyelash product timeline page were misleading in that they “omit and minimize risks associated with Latisse,” an eyelash-enhancing ophthalmic drop.
Regarding the “Evolution of Lash Enhancers” timeline
on the site, DDMAC acknowledged the existence of risk information, but said its presentation – on a “small placard to the lower right” – lacked “a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.” DDMAC declared the efficacy versus risk presentations on the page to be in “stark contrast.”
Further, the aforementioned placard did not convey the risk of hair growth outside of the treatment area, or state that Latisse should not be applied to the lower eyelid, according to DDMAC. “We note the statements, ‘Full prescribing information is available at www.latisse.com and www.allergan.com. Also available here.' However, these statements do not mitigate this misleading omission and minimization of risk information,” the letter said.
The FAQs and About Safety pages on the site also minimize and omit risks, such as the possible contamination of Latisse or the applicators (resulting in bacterial keratitis), or the potential for excess hair growth outside of the treatment area, the letter said, before detailing several other problematic wordings on the pages.
DDMAC asked Allergan to immediately take down the webpages in question, and provide a written response to the letter by September 24.
The Latisse warning letter is the second Allergan has received in less than a month. In August, DDMAC warned
the company about a journal ad for Aczone Gel, an acne medication.