OPDP finds fault with Rapaflo website

A website indicating that Actavis's alpha-blocker Rapaflo capsules can improve sleep and daytime productivity prompted an untitled letter from the FDA's Office of Prescription Drug Promotion.

The drug is approved to treat benign prostatic hyperplasia, which can include symptoms such as nighttime urination. The site shows a man getting up to go the bathroom at night and is accompanied by the text “BPH symptom relief that works nights so he can work days.”

OPDP said the ad is misleading because Rapaflo is indicated for the condition's symptoms, but the research that supported the drug's approval did not address nighttime urination, sleep or productivity at work.