The FDA’s Office of Prescription Drug Promotion issued an untitled letter to Pfizer for a misleading direct-to-consumer online video for its Estring (estradiol vaginal ring) treatment for moderate-to-severe painful sex and vaginal discomfort after menopause.
The agency said the video depicts an interview featuring paid and trained Pfizer spokespeople making false claims about the risks associated with the product. The drug is associated with numerous risks and carries boxed warnings for endometrial cancer, breast cancer, probable dementia and cardiovascular disorders.
“By omitting the risks associated with Estring, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” the letter states. “This misleading presentation is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”