FDA sent a letter to the pharmaceutical giant last week asking it to stop disseminating promotional material that FDA deemed violated the agency’s regulations.
According to the regulatory agency the negative side effects that could result from using the product, such as increased iris pigmentation and risk of infection from the applicators, are played down.
On the product website the company illustrates the history of eyelash enhancing techniques with a timeline, culminating with the introduction of Latisse. According to FDA, the display fails to present risk information with a prominence comparable to information presented about the product’s benefits.
In addition, the ‘FAQ’ and ‘About Safety’ ‘omit and minimize risks associated with Latisse treatment’, according to FDA.
The risks of using the product with contact lenses and of bacterial contamination are omitted from this section of the website, as is the risk of hair growing in areas other than the treatment area, said the regulatory agency in the letter.
Furthermore, although the company mentions eye itching and redness as potential side effects it says these symptoms ‘are not allergic reactions, and do not mean that your eyes are being harmed’.
According to FDA these statements ‘misleadingly’ state that eye itching and redness are not associated with allergic reactions, when these are frequent symptoms of such a reaction.
FDA has asked the company to respond by September 24 and cease using this promotional material.
Potential big earner for the company
Allergan was not immediately available for comment at the time of publishing.
Latisse was recently approved by FDA as the first drug to help promote eyelash growth and the company has high hopes for the drug. Late last year it estimated annual sales of over $500m from the product.
Latisse’s active ingredient is bimatoprost ophthalmic solution and its eyelash enhancing effect was discovered as a side effect when used as a glaucoma treatment.