Hydrocodone in Unapproved Drugs

Scott Kappes

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Friday the FDA posted a warning to healthcare professionals and consumers about the presence of hydrocodone in certain unapproved drugs. Hydrocodone is a powerful narcotic painkiller and cough suppressant and has been of the most commonly abused drugs out there. Abuse can lead to serious injury and even death in some cases. It has been reported to the FDA that several cough suppressants not approved by the FDA contain this dangerous narcotic.

The FDA is most concerned by the fact that some of these unapproved medicines are undoubtedly being used to suppress coughs in children, which could cause serious complications. There have not been any cough suppressants containing hydrocodone approved by the FDA for treating children under the age of six. The FDA has uncovered some hydrocodone cough suppressants with prescription instructions for children as young as two years old.

Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.

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