FDA reprimands Pfizer for leaving risk information out of Estring video

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The FDA has slapped Pfizer with a warning letter for a video promoting Estring, its treatment for painful postmenopausal sex, for not including risk information and making false or misleading claims about its efficacy.


The video, an interview between a doctor and patient who are both identified as Pfizer spokespeople, appeared on the blog Michigan Mom Living in May 2017. Both the post and YouTube video have been removed.


The FDA letter said that the video did not communicate risk information, instead referring viewers to Estring's patient website for more information. The FDA said the reference does not make up for omitting risk information from the video.


The patient featured in the video said she did not experience side effects. Although the FDA acknowledged that might have been her experience, it said her statement suggested other patients might expect not to experience side effects, as well. The government agency said it was particularly concerned about that because Estring contains a boxed warning for serious side effects including endometrial cancer, breast cancer, cardiovascular disorders, and probable dementia.


The FDA letter noted that at the end of the video the interviewer asked, “Is there anything we didn't cover in this interview?,” but the doctor did not mention risk information or side effects.


The FDA also took Pfizer to task for misleading claims about efficacy of the treatment. The patient in the video said, “Once we came up with the plan and I began using the product, it was pretty much an instant relief.”


The FDA again contended that the statement could be interpreted as saying that all patients will have “instant relief” after using Estring, when it typically requires some time to start reducing symptoms. The FDA also invited Pfizer to submit data supporting the instant relief claim.


A Pfizer representative did not immediately respond to a request for comment.


This warning letter is only the second from the Office of Prescription Drug Promotion this year. The first was sent to Collegium Pharmaceutical in February for a conference exhibit booth promoting the painkiller Xtampza ER without including risk information.


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