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.

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.

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 Palladone™, an extended-release product, which was recently withdrawn from the market, has a longer duration of action and requires only once a day administration.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.

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.

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.

Hydromorphone products are in schedule II of the Controlled Substances Act of 1970.