The regulator warned the company that its professional EstroGel Zazzle card is misleading and misbrands the menopause treatment because it omits risk information associated with use of EstroGel.

EstroGel is indicated to treat “moderate to severe vasomotor symptoms due to menopause” and “moderate to severe symptoms of vulvar and vaginal atrophy due to menopause,” and its use is associated with a several serious risks, the FDA letter states. Boxed warnings are included in the PI, as are a number of other warning and precautions.

According to the letter, while the Zazzle card includes efficacy claims, it omits important risk information associated with the use of EstroGel – causing it to misleadingly suggest the treatment is safer than shown. The FDA cited the Zazzle card’s failure to include information from the boxed warning that EstroGel shouldn’t be used to prevent cardiovascular disorders or dementia, as an example. ASCEND also omitted conditions for which EstroGel is contraindicated.

The letter notes the company’s inclusion of the statements “Please visit www.estrogel.com for additional information” and “See enclosed full PI and boxed warning” fails to mitigate the exclusion of important risks.