FDA's OPDP finds flaws with Luitpold video | American Pharmacists Association
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Scientist Advertisement FDA's OPDP finds flaws with Luitpold video Share This PageFebruary 13, 2015FDA's Office of Prescription Drug Promotion (OPDP) recently sent a letter to Luitpold Pharmaceuticals over a video promoting its injected iron-deficiency treatment ferric carboxymaltose (Injectafer).
FDA's Office of Prescription Drug Promotion (OPDP) recently sent a letter to Luitpold Pharmaceuticals over a video promoting its injected iron-deficiency treatment ferric carboxymaltose (Injectafer). The letter expressed concerns about claims it said go beyond the approved indication and misrepresentations about just what the medication is capable of achieving. For example, the Luitpold video says the drug is "for patients with iron deficiency anemia caused by any disease." OPDP noted that FDA approved the drug for a clear set of patients: those who cannot tolerate oral iron, have an unsatisfactory response to orals or patients suffer from non-dialysis dependent chronic kidney disease. OPDP also said the risk information in the video "is displayed on-screen for approximately 30 seconds of the nearly seven-minute video segment." The small-type risk information is made even harder to read because it is not offset by a contrasting color background, according to OPDP.
Medical Marketing & Media (02/10/15) Weinstein, Deborah
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