Hydrocodone (Trade Names: Vicodin®, Lortab®) April 2004
DEA/OD/ODE/200404
Hydrocodone diversion and abuse have been escalating
in recent years. Since 2000, the DEA has conducted over
1,500 investigations involving hydrocodone products. In
2003, hydrocodone was the most frequently encountered
opiate pharmaceutical in drug evidence submitted to the
National Forensic Laboratory Information System with
11,098 exhibits; the System to Retrieve Investigational
Drug Evidence (STRIDE) analyzed 468 exhibits. In the
Drug Abuse Warning Network (DAWN) hospital emergency
department episodes, hydrocodone ranked sixth among all
controlled substances in 2002, with 25,197 episodes.
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 US with over 110 million prescriptions for
hydrocodone-containing products dispensed in 2003. 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®). Examples of other
combination products include those containing aspirin (Lortab
ASA®), ibuprofen (Vicoprofen®) and antihistamines (Hycomine®).
Chemistry/Pharmacology:
Hydrocodone
[4,5a-epoxy-3-methoxy-17-methylmorphinan-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 in the
U.S. was published in 1961.
Illicit Uses:
Hydrocodone is abused for its opiate effects. It is
equipotent to morphine in relieving abstinence symptoms
from chronic morphine administration. 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
with 5, 7.5 and 10 mg doses of hydrocodone being most
common. Hydrocodone is generally abused orally, often in
combination with alcohol.
As with most opiates, abuse of hydrocodone is
associated with tolerance, dependence, and, possibly,
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. Various mechanisms have been proposed to account
for this sparing effect.
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. DAWN data suggests that the most likely
hydrocodone abuser is a white female, age 20-40 years,
who abuses the drug because she is dependent or is
trying to commit suicide. However, hydrocodone-related
deaths have been reported for all age groups. There were
592 hydrocodone-related deaths reported by DAWN in 2001
and 618 in 2002.
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 2003, 61,483 tablets, 534
capsules, 179 grams and 11, 958 ml were submitted to
STRIDE. Doctor shopping, altered or fraudulent
prescriptions, bogus call-in prescriptions, diversion by
unscrupulous physicians and pharmacists, and drug theft
are major sources of the diverted drug.
Control Status:
Congress placed hydrocodone (bulk or single entity
products) in Schedule II of the CSA and combination
products in both Schedule III and V (depending on
hydrocodone concentration) when the CSA was enacted in
1970.
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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