HHS sends warning letter on Latisse

After reviewing two sections of a consumer Web site for Latisse (bimatoprost ophthalmic solution 0.03%, Allergan, Irvine, Calif.), the Division of Drug Marketing, Advertising, and Communications, has determined the promotional materials are misleading “because they omit and minimize risks associated with Latisse,” the Food and Drug Administration (FDA) said in its letter to Allergan. According to the FDA, a small display on risk information that is presented is “on a small placard to the lower right of the timeline exhibit. As such, this display fails to present risk information with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.” The FDA also said the risk information presented omits important risks. Noting that the Web site directs consumers to the full prescribing information at the product’s Web site does not “mitigate this misleading omission and minimization of risk information.” Likewise, the FDA said, the “FAQs” and “About Safety” Web pages are misleading because they omit and minimize risks associated with the treatment. Eye itching and redness are not associated with allergic reactions of the eyes related to Latisse treatment, according to the Web sites, and the FDA has determined that is also misleading.

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