Oxycodone hydrochloride (OxyContin) (July 30, 2001)

The US Food and Drug Administration (FDA) has issued stronger warnings and precautions about when to prescribe the long-acting opioid oxycodone hydrochloride (OxyContin) because a growing number of reports indicate that the drug is being abused.

The drug

Oxycodone is an opioid analgesic that is approximately twice as potent as an equivalent dose of morphine when taken orally. OxyContin is approved for the treatment of moderate and severe pain. The medication is typically dosed every 12 hours because the intact tablet works on a controlled-release principle. The FDA says abusers are circumventing this by crushing the pills and either injecting or snorting the resulting powder. At least 100 deaths have been linked to the drug in the US.

A letter was sent to US physicians on July 18, 2001, saying that the drug should not be used as a prn medication nor to treat mild or temporary pain or pain that develops in the immediate postoperative period (http://www.fda.gov/medwatch/safety/2001/oxycontin.htm).

An overdose may be characterized by respiratory depression, extreme somnolence and coma, muscle flaccidity, cold and clammy skin and, occasionally, bradycardia and hypotension; severe overdose may lead to apnea, circulatory collapse, cardiac arrest and death. For other adverse effects, consult the product monograph.

Physicians are reminded of the potential for abuse, misuse and diversion of oxycodone. In Canada oxycodone exists in regular oral, controlled-release oral and combination preparations sold under various trade-names: OxyContin, Supeudol, Endocet, Oxycocet, Percocet, Percocet-Demi, Endodan, Oxycodan, Percodan, and Percodan-Demi.

What to do

Appropriate pain management is to be stressed, and OxyContin should be reserved for expected moderate or severe persistent pain. Physicians should be aware of the potential for abuse of this specific preparation, and stress to patients that the drug is to be swallowed whole and not chewed or crushed, because this can release potentially lethal amounts of the medication. The opioid antagonist naloxone HCl is a specific antidote against opioid-induced respiratory depression. However, in individuals physically dependent on opioids, opioid antagonists should be used with caution (see monograph for details) because of the potential for serious acute withdrawal syndrome. — Dr. Eric Wooltorton, eCMAJ