Advisory
2005-84
August 3, 2005
For immediate release
Potentially fatal interaction between slow-release Opioid painkillers and alcohol
OTTAWA - Health Canada is advising Canadians of serious health risks when consuming alcohol while taking any type of slow-release painkillers known as opioids. These medications are used for the relief of severe pain over a prolonged period of time.
This advisory follows information from Purdue Pharma indicating that its slow-release opioid medication, Palladone XL, may cause serious and potentially fatal problems when taken at the same time with any amount of alcohol. Purdue Pharma has not shipped any Palladone XL to Canada since December 2004 and Health Canada has confirmed that there are no supplies of Palladone XL currently on the Canadian market. On July 13, 2005, for these same issues of interaction with alcohol, the United States Food and Drug Administration instructed Purdue Pharma to withdraw Palladone from the U.S. market.
This safety issue may be limited to Palladone XL, but patients using other slow-release opioid products should be aware that there may be a possibility that these products could react in the same way when taken with alcohol. Alcohol consumption would include drinking beer, wine or distilled spirits, or taking any other prescription or over-the-counter medicines that contain alcohol. If individuals have questions about the alcohol content of medications they are taking, they should consult their pharmacist.
Palladone XL capsules contain a slow-release form of a medication called hydromorphone. When taken with alcohol, potentially dangerous levels of hydromorphone are released quickly into the blood stream, instead of over a 24-hour period as should be the case. This effect is known as dose dumping.
Slow-release medications may also be described as extended release, controlled release and controlled delivery. They may also carry such abbreviations as SR, XR, XL, SRC and SRT.
Other slow-release opioids sold in Canada include:
- Hydromorph Contin (hydromorphone)
- Kadian SRC (morphine sulfate)
- M.O.S. SR (morphine hydrochloride)
- M-Elson (morphine sulfate)
- MS Contin SRT (morphine sulfate)
- Oxycontin SRT (oxycodone)
- PMS-Morphine Sulfate SR (morphine sulfate)
- Ratio-Morphine SR (morphine sulfate)
- Roxanol SR (morphine sulfate)
- Zomorph (morphine sulfate)
To determine whether this effect might occur with slow-release drugs other than Palladone XL, Health Canada is requesting that all manufacturers of these drugs provide data on the interaction of their product with alcohol. If they cannot do so, they will be asked to conduct studies on product interaction with alcohol, and these studies are expected to be completed within six months.
Health Canada will assess the data within a three-month period and take further action if needed. Health Canada will keep consumers and health professionals informed.
Until Health Canada's assessment is completed, the issue of possible dose dumping related to alcohol consumption (immediate release of a potentially dangerous level of medication instead of over a 24-hour period) will be included in the prescribing information for all slow-release opioid medications. This change will be a temporary one until the results of these studies are available.
No adverse reactions to Palladone XL have been reported to Health Canada. The doctor and patient information contains warnings against the consumption of alcohol while using Palladone XL, similar to warnings provided with other medication. While it is unlikely that any Canadians are taking Palladone XL at this time, anyone doing so should speak to their doctor about obtaining an alternative treatment.
All opioid medications currently carry warnings against the consumption of alcohol while taking the drug because of the potential for serious and even fatal reactions.
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Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988
Public Inquiries:
(613) 957-2991
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