FDA tackles illegal hydrocodone products

The U.S. Food and Drug Administration has announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs.

The action does not affect other hydrocodone formulations, which have FDA approval.

Hydrocodone is one of the strongest medications available to treat pain or to suppress cough. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. As part of the drug approval process, the agency considers the possibility of medication errors and name confusion, so that potential safety issues associated with these factors can be minimized.