FDA cracking down on bad ads for stimulants on the internet

Abstract

The FDA's Office of Prescription Drug Promotion, after reviewing a link for ProCentra (dextroamphetamine sulfate) on Google, sent a warning letter to Outlook Pharmaceuticals saying that the “link is false or misleading in that it presents information about the benefits of ProCentra, but fails to include any risk information about the drug.” There's nothing wrong with the medication, which is approved by the FDA. But there is something wrong with the ad, and the FDA wanted it off the internet immediately. The company called it ProCentra only, never naming the established name, which constitutes misbranding within the federal Food, Drug, and Cosmetic Act and makes distributing it a violation. “These are especially concerning from a public health perspective because they create a misleading impression about the safety of ProCentra, a drug that is a schedule II controlled substance used in the vulnerable pediatric patient population, and bears a Boxed Warning that describes the high potential for abuse, that administration of amphetamines for prolonged periods of time may lead to drug dependence, and states that misuse may cause sudden death and serious cardiovascular adverse events,” the letter states.