Drugs and Chemicals of
Concern > Hydromorphone
HYDROMORPHONE
(Trade name: Dilaudid®; Street Names:
Dust, Juice, Smack, D, Footballs)
September 2007
DEA/OD/ODE
Introduction:
Hydromorphone is a potent schedule II
opioid analgesic drug available on the market. It is marketed as injectable
ampoules, multiple dose vials, tablets and suppositories. The diversion and
abuse of hydromorphone is increasing.
Licit Uses:
Hydromorphone is used for relief of
moderate to severe pain in patients where an opioid analgesic is appropriate.
Prescriptions for hydromorphone products have increased by 228 percent, from
about 0.47 million in 1998 to 1.83 million in 2006. Aggregate production quota
for hydromorphone as established by DEA for legitimate national needs
increased from 766 kilograms in 1998 to 3,300 kilograms in 2006.
On September 24, 2004, the Food and Drug
Administration (FDA) approved for marketing an extended release capsule
formulation (Palladone™) containing 12, 16, 24 and 32 mg hydromorphone.
Palladone™, was indicated for the management of persistent, moderate to
severe pain. Its use was restricted to opioid-tolerant patients requiring
continuous, around-the-clock analgesia with a high potency opioid for an
extended period of time (weeks to months) or longer.
Within 6 months following the launch of
Palladone™, new data was provided by the sponsor of Palladone™, to the FDA
showing that drinking alcohol while taking Palladone™ may cause rapid
release (dose dumping) of hydromorphone, leading to high drug levels in the
body, with potentially fatal effects. In view of these new data and at the FDA’s
request, the sponsor suspended the sales and marketing of Palladone™ in July
2005.
Chemistry/Pharmacology:
Hydromorphone,
[4,5-epoxy-3-hydroxy-17-methylmor-phinan-6-one, dihydrohydroxycodeinone;
dihydromorphinone; dimorphone] is a semi-synthetic opioid agonist derived from
morphine. It will test positive for an opiate in the available field test
kits. Pharmacological and toxic effects, clinical indications and
contraindications, abuse and dependence liabilities of hydromorphone are
essentially similar to those of other schedule II opioid analgesics such as
morphine, oxycodone, etc. In humans, the doses of 1.3 and 7.5 mg hydromorphone
produces analgesia equivalent to that produced by 10 and 30 mg morphine when
taken by the intramuscular and oral routes, respectively. The analgesic action
of hydromorphone is perceived within 15 and 30 minutes following its
administration through injection and oral routes, respectively. The analgesic
action usually lasts for more than 5 hours. Palladone™, an extended-release
product, which was recently withdrawn from the market, has a longer duration
of action and requires only once a day administration. Similar to other
opioids, hydromorphone produces euphoria, feelings of relaxation, reduced
anxiety, respiratory depression, sedation, constipation, papillary
constriction, and cough suppression. Acute overdose of hydromorphone can
produce severe respiratory depression, somnolence progressing to stupor or
coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils,
reduction in blood pressure and heart rate, and death. Pure opioid antagonists
such as naloxone are specific antidotes against respiratory depression from
hydromorphone overdose.
Illicit Uses:
Hydromorphone abuse has been a
continuing problem in the United States. Hydromorphone, similar to other
schedule II opioids, has a high abuse and dependence potential and produces
tolerance. Prior to the current popularity of hydrocodone and oxycodone among
drug abusers, low dose (2 and 4 mg) immediate release hydromorphone
formulations (i.e., Dilaudid) were the leading opioid products for abuse and
diversion. Street names for Dilaudid are Dust, Juice, Dillies, Smack, D and
Footballs. Abuse of hydromorphone is mainly among rural and suburban
populations.
Illicit Distribution:
The main sources of hydromorphone diversion include
forged prescriptions, "doctor-shoppers," unscrupulous pharmacists
and physicians, armed robberies, night break-ins of pharmacies and nursing
homes. Recently, the diversion of Dilaudid has been reported by a number of
DEA field offices including, Atlanta, Boston, Chicago, Dallas, Detroit,
Houston, Los Angeles, New York, San Antonio, St. Louis, and Washington D.C.
The street price of a 4 mg tablet of Dilaudid, the most common dosage strength
reported, ranges from $5 to $100 per tablet depending on the region. In 2004,
1.44 million people aged 12 or older used Dilaudid® for nonmedical use at
least once during their life time (National Survey on Drug Use and Health,
2004). According to the System to Retrieve Information from Drug Evidence, a
federal database for drug seizures analyzed by DEA laboratories, there were
39, 31, 42, 31 and 24 hydromorphone seizure records in 2002, 2003, 2004, 2005
and 2006, respectively. According to the National Forensic Laboratory
Information System, state and local forensic laboratories analyzed 659, 584,
762, 1067 and 1272 hydromorphone drug items in 2002, 2003, 2004, 2005 and
2006, respectively.
Control Status:
Hydromorphone products are in schedule
II of the Controlled Substances Act of 1970.
Comments and additional information are welcome by the Drug
and Evaluation Section, FAX 202 353-1263, telephone 202 307.7183.
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