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Painkiller’s Ads Hype New Combo of Old Drugs

Posted by medconsumers on February 1, 2006

Combunox:

Combunox is advertised by Forest Pharmaceuticals as though it were a new drug. Actually, it is a combination of two old drugs: the semi-synthetic opioid prescription drug, oxycodone, plus the popular over-the-counter anti-inflammatory painkiller, ibuprofen. The combination supposedly provides an extra punch. But The Medical Letter (1/2/06), a physician publication without drug advertising, assessed the studies supporting the use of this fixed combination drug and concluded that people with acute pain might be better off taking ibuprofen alone.

At a dose of 400 mg (the amount in Combunox), ibuprofen is doing the lion’s share of the painkilling. “A 400-mg dose of ibuprofen is generally superior to 1000 mg dose of acetaminophen (brand name: Tylenol) and is comparable to acetaminophen/codeine combinations,” according to The Medical Letter. “The analgesic effect of ibuprofen does not increase with doses greater than 400 mg; the anti-inflammatory effect does and so does the drug’s gastrointestinal toxicity.”

Who were the study participants?

In one clinical trial, Combunox was better than a placebo in women with moderate to severe pain 14 to 48 hours after abdominal or pelvic surgery, and in another trial that involved people who have had dental surgery.

What’s New About Combunox?

Not much. Oxycodone was introduced over 50 years ago and reintroduced in the ensuing years under numerous brand names (including OxyContin and Percolone) and in combination with over-the-counter painkillers, such as aspirin/oxycodone (Percodan) and acetaminophen/oxycodone (Percocet). Combunox represents the first time oxycodone has been combined with ibuprofen.

Cautions

Combunox is approved for the short-term (seven days) treatment for moderate to severe acute pain because prolonged use can lead to dependence. The warning is based on longstanding concerns about oxycodone. As with all opioids, abuse is a strong possibility. Under its most popular brand name OxyContin, oxycodone has received considerable media attention because of continuing reports of abuse. One risk of taking a fixed combination, according to The Medical Letter is this: Dependence upon oxycodone may cause people to increase the dose, which in turn could lead to overdosage of ibuprofen.

Alternatives

A week’s supply of Combunox costs $10.08 to $40.32, says The Medical Letter, whereas, the same amounts of generic ibuprofen and oxycodone would cost $4.80 to $19.20. The Medical Letter findings suggest that 400 mg of ibuprofen alone might be the safest choice.

Maryann Napoli, Center for Medical Consumers ©
February 2006

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