The FDA’s Office of Prescription Drug Promotion (OPDP) sent its first warning letter of the year to Outlook Pharmaceuticals of Cincinnati, Ohio over a sponsored link for its ADHD treatment ProCentra (dextroamphetamine sulfate).
The link, which appeared on Google searches, explained the benefits of ProCentra without communicating any of its risks, the agency said.
The advertisement also used wording that appealed to children — such as “Bubble Gum Flavor” — but left out that the drug is a schedule II controlled substance with a high potential for abuse.
OPDP also said that the link misbranded ProCentra because it did not list its established name, dextroamphetamine sulfate, next to the proprietary name.
The letter noted that the agency received multiple complaints about the sponsored link via its Bad Ad Program, which allows healthcare providers to report misleading drug promotions.