The FDA has approved the marketing of a new device for delivering lidocaine to the skin of children undergoing a venipuncture or intravenous (IV) line placement. Zingo (Anesiva) is a powder intradermal injection system.

The FDA has approved ziconotide (Prialt - Elan) intrathecal infusion for management of severe chronic pain in patients who are intolerant of or refractory to other treatments. Ziconotide is a synthetic neuronal N-type calcium channel blocker. It is intended for use with a programmable implanted microinfusion device, but an external microinfusion device can be used temporarily.

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).

In our January 17 issue, a short article on NSAID alternatives mentioned that tramadol (Ultram, and others), a weak opioid analgesic, could be helpful for some patients. A few readers have commented that we should have said something about its drawbacks. The need for slow titration in dosage limits the drug's use for treatment of acute pain. Seizures have been reported with tramadol; patients taking an antidepressant or an antipsychotic drug may be at increased risk. Tramadol is not a controlled substance, but psychological and physical dependence have occurred.

Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) may be asking their health care providers if they should continue, and some may be asking for alternatives. For most patients taking nonspecific NSAIDs, it would be reasonable to continue. For those who are taking the COX-2 selective celecoxib (Celebrex) because they cannot tolerate the gastrointestinal (GI) effects of nonspecific NSAIDs, it seems reasonable to continue at doses no higher than 100 mg b.i.d. or 200 mg once daily; at these dosages cardiovascular risk has been no higher than with placebo. All NSAIDs, including COX-2 inhibitors, can decrease renal blood flow and cause fluid retention, hypertension and renal failure, especially in the elderly and in patients who take diuretics. The unpublished study that led to an FDA alert on an increased cardiovascular risk with naproxen (Naprosyn, and others) was conducted in patients older than 70. See NSAID addendum

With the removal of Vioxx from the market and concerns about cardiovascular toxicity with other selective COX-2 inhibitors, patients are looking for safe alternatives, and manufacturers of other drugs are looking for additional market share. The COX-2 inhibitors first became popular because they have less upper GI toxicity than older less selective NSAIDs, at least in the short term, in patients not taking aspirin.

Gabapentin (Neurontin - Pfizer), which has been available in the US since 1994, is approved by the FDA only for treatment of partial epilepsy and postherpetic neuralgia, but is widely used off-label for a number of other indications, especially neuropathic pain syndromes. According to one report, among Medicaid recipients in Florida receiving gabapentin, 71% of prescriptions were for chronic pain and 8% for seizures and neuralgia ("The Pink Sheet" February 2, 2004; 66:30).

Valdecoxib (Bextra - Pharmacia/Pfizer), a selective cyclooxygenase (COX-2) inhibitor similar to celecoxib (Celebrex) and rofecoxib (Vioxx), was recently approved by the FDA for treatment of osteoarthritis, rheumatoid arthritis and primary dysmenorrhea.

Recent reports of inappropriate use and diversion of OxyContin tablets have prompted Purdue Pharma to include a "Black Box Warning"in the product labeling to call attention to the potential for abuse and to reinforce the FDA-approved indication "...for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time..."

Since the implication of aspirin in Reye's syndrome, acetaminophen (Tylenol; and others) has become the standard drug for symptomatic treatment of fever and pain in children. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) available for many years in tables (Mortin; Advil; and others), has now become available in a suspension. The suspension will be sold by presecription for treatment of fever or arthritis in children.

Automated intravenous delivery systems have recently become commercially available for intermittent self-administration of analgesics. Patient-controlled analgesia (PCA) has been used effectively to relieve after a wide variety of surgical procedures. It has also been effective for pain associated with labor, sickle cell crisis, and chronic pain caused by cancer.