Hydromorphone is one of the most potent Schedule II opioid analgesic
drugs available on the market. It is marketed as injectable ampoules (1,
2, and 4 mg/mL) and multiple dose vials (20 mL of 2 mg/mL), tablets (2,
4, and 8 mg) and suppositories (3 mg). 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. The prescriptions for hydromorphone products have
increased by 106 percent, from about 470,000 in 1998 to 970,000 in 2003.
Recently physicians have been prescribing hydromorphone as an
alternative to OxyContin®. Aggregate production quota for hydromorphone
as established by DEA for legitimate national needs increased from 766
kilograms in 1998 to 1,651 kilograms in 2003. Recent data indicate that
the diversion and abuse of hydromorphone and its resultant health
consequences are increasing. According to the Drug Abuse Warning Network
(DAWN), the estimated number of emergency department (ED) episodes
involving hydromorphone increased from 937 in 1996 to 2,667 in 2002.
Licit Uses
Hydromorphone is indicated for the relief of moderate to severe pain
in patients where an opioid analgesic is appropriate. Like morphine,
adequate doses of hydromorphone will relieve even the most severe pain.
Palladone™, the extended release hydromorphone product, is indicated
for the management of persistent, moderate to severe pain. Its use is
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. Patients need to swallow
Palladone™ capsules whole because breaking, chewing, opening,
dissolving or crushing of the capsules can lead to the absorption of
potentially lethal doses.
Chemistry/Pharmacology
Hydromorphone, [4,5-epoxy-3-hydroxy-17-methylmorphinan-6-one,
dihydrohydroxycodeinone; dihydromorphinone; dimorphone] is a
semi-synthetic opioid agonist derived from morphine. Hydromorphone HCl
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 five hours. Palladone™, as an extended-release product, 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, 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 or nalmefene
are specific antidotes against respiratory depression from hydromorphone
overdose. Palladone™ exposure has a risk of producing fatal
respiratory depression in children, especially small children.
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
during the 1970’s and 1980’s. As early as 1979, the DEA initiated a
targeted investigation program for hydromorphone. Some street names for
Dilaudid are Dust, Juice, Dillies, Smack, D and Footballs. The abuse of
hydromorphone, similar to other prescription opioids, is mainly among
rural and suburban populations. The large amount of hydromorphone (12 to
32 mg) present in Palladone™ makes this product highly susceptible for
diversion and abuse by opioid abusers and doctor shoppers.
Illicit distribution
The main sources of hydromorphone diversion have been through forged
prescriptions, "doctor-shoppers", unscrupulous pharmacists and
physicians, and armed robberies and night break-ins of pharmacies and
nursing homes. Recently, the diversion of Dilaudid has been reported by
a number of DEA field offices including, New York, Chicago, St. Louis,
San Antonio, Atlanta, Boston, Dallas, Detroit, Houston, Los Angeles, and
Washington, DC. 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. According to the System to Retrieve Information
from Drug Evidence, a Federal database for drug seizures, there were 39
and 31 hydromorphone seizure records in 2002 and 2003, respectively.
State/local seizures of hydromorphone products as reported in the
National Forensic Laboratory Information System were 621 and 485 in 2002
and 2003, respectively.
Control status
Hydromorphone products are in Schedule II of the Controlled
Substances Act of 1970.
