HYDROCODONE 
(Trade Names: Vicodin®, Lortab®, Lorcet®, Hycodan®, Vicoprofen®)

October 2009 DEA/OD/ODE

Hydrocodone diversion and abuse has been escalating in recent years. In 2008, hydrocodone was the most frequently encountered opioid pharmaceutical (37,804 items) in drug evidence submitted to state and local forensic laboratories as reported by the National Forensic Laboratory Information System (NFLIS). During the first six months of 2009, 20,128 hydrocodone items were reported by NFLIS. DEA forensic laboratories identified 473 hydrocodone items/exhibits in 2008 and 294 items/exhibits from January to June 2009. The total number of drug items seized and reported to federal, state, and local laboratories has increased by 109% since 2004. The DEA is currently reviewing a petition to increase the regulatory controls on hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act (CSA).

Hydrocodone is an antitussive (cough suppressant) and analgesic agent for the treatment of moderate to moderately severe pain. Studies indicate that hydrocodone is as effective, or more effective, than codeine for cough suppression and nearly equipotent to morphine for pain relief.

Hydrocodone is the most frequently prescribed opiate in the United States with more than 136 million prescriptions for hydrocodone-containing products dispensed in 2008 (IMS Health™). There are several hundred brand name and generic hydrocodone products marketed. All are combination products and the most frequently prescribed combination is hydrocodone and acetaminophen (Vicodin®, Lortab®).

Hydrocodone [4,5α-epoxy-3-methoxy-17-methyl-morphinan-6-one tartrate (1:1) hydrate (2:5), dihydrocodeinone] is a semi-synthetic opioid most closely related to codeine in structure and morphine in producing opiate-like effects. The first report, that hydrocodone produces euphoria and habituation symptoms, was published in 1923. The first report of hydrocodone dependence and addiction was published in 1961.

Hydrocodone is abused for its opioid effects. Widespread diversion via bogus call-in prescriptions, altered prescriptions, theft and illicit purchases from Internet sources are made easier by the present controls placed on hydrocodone products. Hydrocodone pills are the most frequently encountered dosage form in illicit traffic. Hydrocodone is generally abused orally, often in combination with alcohol.

Of particular concern is the prevalence of illicit use of hydrocodone among school-aged children. The 2008 Monitoring the Future Survey reports that 2.9%, 6.7% and 9.7% of 8^th, 10^th, and 12^th graders, respectively, used Vicodin^® nonmedically in the previous year.

The American Association of Poison Control Centers (AAPCC) reports that in 2007, there were 24,558 case mentions, 11,001 single exposures and 23 deaths associated with hydrocodone. According to the 2008 National Survey on Drug Use and Health (NSDUH), 22,838 people aged 12 and older used hydrocodone for nonmedical purposes in their lifetime.

As with most opiates, abuse of hydrocodone is associated with tolerance, dependence, and addiction. The co-formulation with acetaminophen carries an additional risk of liver toxicity when high, acute doses are consumed. Some individuals who abuse very high doses of acetaminophen-containing hydrocodone products may be spared this liver toxicity if they have been chronically taking these products and have escalated their dose slowly over a long period of time.

Every age group has been affected by the relative ease of hydrocodone availability and the perceived safety of these products by medical prescribers. Sometimes viewed as a "white collar" addiction, hydrocodone abuse has increased among all ethnic and economic groups.

Hydrocodone has been encountered in tablets, capsules, and liquid form in the illicit market. However, hydrocodone tablets with the co-ingredient, acetaminophen, are the most frequently encountered form. Hydrocodone is not typically found to be clandestinely produced; diverted pharmaceuticals are the primary source of the drug for abuse purposes. In 2006, the DEA has documented the diversion of millions of dosage units of hydrocodone from illicit Internet sources. Doctor shopping, altered or fraudulent prescriptions, bogus call-in prescriptions, diversion by unscrupulous physicians and pharmacists, and drug theft are also major sources of the diverted drug.

The U.S. Congress placed hydrocodone (bulk or single entity products) in schedule II of the CSA and its products containing specified doses in combination with specified amounts of isoquinoline alkaloid of opium or one or more nonnarcotic substances in recognized therapeutic amounts as schedule III products when the CSA was enacted.

Comments and additional information are welcomed by the Drug and Chemical Evaluation Section, Fax 202-353-1263, telephone 202-307-7183, or E-mail ODE@usdoj.gov.

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