FDA Takes Action against Unapproved Hydrocodone Product Marketing

Federal regulators took the extraordinary step of announcing enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a widely abused opioid used primarily in concert with analgesics and over-the-counter cough suppressants.

The government has taken this action in the face of widespread popular abuse of hydrocodone formulations, as serious drug events, injury, and reports of death involving hydrocodone have dramatically risen over the past several years.

Industry groups for pharmaceuticals maintain that these hydrocodone cough syrups under fire are registered by the FDA but not vetted under the current approval process, and have been sold in pharmacies for decades. Nonetheless, companies marketing unapproved hydrocodone products have until year’s end to stop marketing before action will be taken by government regulators.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.