FDA Takes Action on Unapproved Prescription Drugs That Contain Hydrocodone

200 Cough Suppressants to Be Impacted

According to the United States Food and Drug Administration news release, enforcement of companies marketing unapproved prescription drug products that contain hydrocodone will soon be processed.

Hydrocodone is a medication that treats pain or suppresses coughs. The drug is widely known to cause serious illness, injury, or death if used improperly and is also known for it's popular use for drugs abusers. An overdose of hydrocodone can cause cardiac arrest, as well as impairing your motor skills and judgment.

This new enforcement by the Food and Drug Administration came about after numerous reports of medication errors that had been associated with the formulation changes in the unapproved hydrocodone products. The reports have shown that the errors are associated with the confusion of similarities between those drugs that have been approved, and those unapproved.

There are some hydrocodone products that are approved by the FDA such as Vicodin, however most of the products that contain hydrocodone that are marketed to suppress coughs are not approved. This worries the agency regarding the proper pediatric labeling of those hydrocodone cough suppressants that are not approved due to the risk of medication error.

The FDA has announced that anyone who is marketing or distributing and of the unapproved hydrocodone products that are currently for children under six years-old must halt the manufacturing as well as the distribution by October 31, 2007. It has also been announced that those who are marketing and distributing any other unapproved hydrocodone products must stop manufacturing by December 31,2007. If companies fail to comply with these terms, the FDA will seek further legal action.