FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products

September 28, 2007 – The U.S Food and Drug Administration (FDA), equivalents to the Saudi Food and Drug Authority (SFDA), informed healthcare professionals and consumers in USA of its intent to take action against companies that market unapproved prescription products containing hydrocodone.

Hydrocodone is a member of Opioid class, its widely used as a cough suppressant and to treat pain. 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.

No hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.

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.

Hydrocodone currently is not register in Saudi Arabia.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions of hydrocodone to the National Pharmacovigilance center on the internet at: