Editor note: In July 2005, marketing of Palladone was suspended by the FDA citing potential for severe side effects if Palladone is taken with alcohol.
Dateline: September 24, 2004
Abuse Potential Of Palladone A Concern
Palladone, an opioid-based drug from Purdue Pharma L.P., has been FDA approved for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid pain relief for an extended period of time. Arthritis patients are among those requiring around-the-clock pain relief for their chronic arthritis pain.
Purdue Pharma is the company which makes OxyContin, a controlled substance which has become a news-maker as an abused street drug, rather than for its intended therapeutic indication - pain management.
Palladone Is A Schedule II Controlled Substance
Palladone contains the Schedule II controlled substance hydromorphone (available in extended release formation in 12, 16, 24, and 32 milligram doses) and reportedly has the potential for abuse. The drug comes under the jurisdiction of the DEA (Drug Enforcement Administration).
FDA officials stated Palladone should only be used in patients who:
- are already taking opioid medications.
- need to take at least 12 milligrams of the oral hydromorphone or its equivalent each day.
According to the FDA Talk Paper, "Palladone offers a therapeutic choice for opioid-tolerant patients who might otherwise be candidates for other opioids and who do not achieve satisfactory therapeutic results with these other products."
Aware of the potential for abuse, a risk management program has been developed which will provide:
- clear and appropriate labeling.
- appropriate education of healthcare professionals, patients, and caregivers.
- appropriate training of sales representatives.
- a multifaceted program for monitoring and surveillance of abuse was developed.
Other Risks
On top of the potential for abuse and addiction, if not properly dosed, respiratory depression (shallow breathing even possibly fatal) is the highest risk associated with Palladone.
Palladone must be swallowed whole, and not chewed, dissolved or crushed. If not swallowed whole the contents of the capsule are rapidly absorbed at a potentially fatal dose.
The abuse potential is scary to many people. On a website called OxyABUSEKills.com, a mother, whose daughter died after being prescribed OxyContin and taking it for 4 months, tries to get the attention of U.S. Senators, Attorney Generals and the Associated Press Offices to bring awareness to the severity of the abuse problem with OxyContin. The mother concludes, "If the FDA approves Palladone for moderate pain, I believe it will make OxyContin look like a day at the beach."
Will the concern over OxyContin abuse spill over onto Palladone, making the drug hard to obtain for patients who need it? The abuse issue presents very real problems for people with legitimate medical need.
Related Resources
First published 9/24/2004
