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Drugs and Chemicals of Concern > Hydrocodone

Drugs and Chemicals of Concern


HYDROCODONE

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

November 2008 DEA/OD/ODE

Introduction:

Hydrocodone diversion and abuse has been escalating in recent years. In 2006, hydrocodone was the most frequently encountered opioid pharmaceutical (25,136 items) in drug evidence submitted to state and local forensic laboratories as reported by the National Forensic Laboratory Information System (NFLIS). According to the System to Retrieve Investigational Drug Evidence (STRIDE), DEA forensic laboratories analyzed 654 hydrocodone exhibits in 2006. Poison control data, medical examiners’ reports, and treatment center data all indicate that the abuse of hydrocodone is associated with significant public health risks, including a substantial number of deaths. 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).

Licit Uses:

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 nearly 131 million prescriptions for hydrocodone-containing products dispensed in 2006. 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®).

Chemistry/Pharmacology:

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.

Illicit Uses:

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.

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. Data suggests that 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.

User Population:

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. Of particular concern is the prevalence of illicit use of hydrocodone among school age children. In 2006, the Monitoring the Future Survey (commonly referred to as the high school survey) reported that 3%, 7% and 9.7% of 8th, 10th, and 12th graders, respectively, reported non-medical use of Vicodin® in the previous year.

Illicit Distribution:

Hydrocodone has been encountered in tablets, capsules, and liquid form in the illicit market. However, tablets containing acetaminophen are the most frequently encountered products. Hydrocodone is not clandestinely produced and 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.

Control Status:

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 or telephone 202-307-7183.


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