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On July 13, 2005, the Food and Drug Administration (FDA) asked the maker of the long-acting potent narcotic, or opiate, painkiller hydromorphone (PALLADONE) to remove the drug from the market because of a potentially fatal interaction with alcohol.
This product is manufactured by Purdue Pharma headquartered in Stamford, Conn. It was approved for marketing on September 24, 2004 and has only been on the market for 10 months. The drug was prescribed to be taken once daily and approved for the...
On July 13, 2005, the Food and Drug Administration (FDA) asked the maker of the long-acting potent narcotic, or opiate, painkiller hydromorphone (PALLADONE) to remove the drug from the market because of a potentially fatal interaction with alcohol.
This product is manufactured by Purdue Pharma headquartered in Stamford, Conn. It was approved for marketing on September 24, 2004 and has only been on the market for 10 months. The drug was prescribed to be taken once daily and approved for the treatment of moderate to severe chronic pain in opiate-tolerant patients — that is, patients who have been taking opiate-containing products for a significant length of time.
The problem is not the hydromorphone, which is a useful, very old pain reliever, but the extended-release capsules sold by Purdue Pharma. The FDA reviewed the results of a company-sponsored study showing that alcohol damaged the mechanism that makes Palladone an extended-release product, which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient, in this case hydromorphone, from an extended release product into the blood stream. The consequences of dose-dumping at the lowest available dose — 12 milligrams of Palladone — could lead to serious, or even fatal, adverse events in some patients. The risk is even greater for the higher strengths of the product.
The Purdue Pharma study, conducted in 24 healthy men, showed that compared to taking Palladone by itself, concentrations of hydromorphone in the blood were 5.5 times higher when the 12 milligram Palladone extended release capsules, the lowest dose available, were taken with eight ounces of 40 percent, or 80 proof, alcohol.
The FDA has also asked the manufacturers of two other long-acting morphine products to add new warning language about a possible interaction with alcohol. The manufacturers and products are Ligand Pharmaceuticals’ Avinza and Alpharma’s Kadian.
Of drugs approved since 1992, we count Palladone as the 17th new drug to be removed from the market for a safety reason. The year 1992 was chosen because this was the year that Congress passed the Prescription Drug User Fee Act, or PDUFA. This act allowed the FDA to collect fees from drug companies to approve new drugs faster. This law has fundamentally changed, to the public’s detriment, the relationship between the FDA and the drug industry. The FDA’s primary client now appears to be pharmaceutical manufacturers, not the American public.
What You Can Do
If you are now taking Palladone, Avinza, or Kadian you should talk to your physician immediately to discuss alternative treatment.
