The Medical Letter review of Palladone (hydromorphone HCl) extended-release capsules (March 14, 2005) warned that a lethal dose could be released if the new formulation was taken with alcohol. Because of that risk, the FDA asked the manufacturer (Purdue) to withdraw the drug from the market (FDA News. July 13, 2005; FDC Reports – “The Pink Sheet” July 18, 2005; 67:3).

A once-daily extended-release (ER) oral formulation of the opioid analgesic hydromorphone hydrochloride (Palladone - Purdue Pharma) has been approved by the FDA for treatment of opioid-tolerant patients with persistent moderate to severe pain. Hydromorphone HCl, a semisynthetic congener of morphine and active metabolite of hydrocodone that has been used since the 1920s, is also available in immediate-release oral, injectable and suppository forms (Dilaudid, and others).

The FDA has approved a transmucosal tablet formulation of fentanyl citrate (Fentora - Cephalon) for management of breakthrough pain in opioid-tolerant patients with cancer. An oral transmucosal fentanyl lozenge on a stick (Actiq, and others) is also available for this indication, and is widely used off-label for chronic, non-cancer pain as well.

View the Comparison Table: Some Oral/Transdermal Opioid Analgesics

A new CDC guideline for prescribing opioids for pain recently became available. Nonopioid drugs for pain were reviewed in a previous issue.