FDA LETTER TO PFIZER RAISES CONCERNS ABOUT SAFETY, EFFICACY OF ESTRING
FDA 06/19/2018’s letter to Pfizer about its direct-to-consumer video that “makes false or misleading claims and/or representations about the risks associated with and the efficacy of Estring.” The FDA further states in the letter that “This video is especially concerning from a public health perspective because it fails to include any risk information about Estring, which is a drug that bears a boxed warning due to several serious, life-threatening risks, including endometrial cancer, breast cancer, and cardiovascular disorders, as well as numerous contraindications and warnings. The video thus creates a misleading impression about the safety and efficacy of Estring.”
