On Friday, Nov 19, the U.S. Food & Drug Administration:
• Asked that pain products containing the opioid propoxyphene be removed from the market. Propoxyphene is “an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., the branded drug Darvon) or in combination with acetaminophen (e.g., Darvocet).” Propoxyphene is also found in generic versions. The drug was banned in the UK in 2005, and by the EU in 2009.
• Issued safety alerts & warnings to physicians, pharmacists, and consumers, “advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.” To view the FDA’s brief consumer advisory video, click HERE.
• Explained in a press release that “We now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart…” by causing “significant changes to the electrical activity of the heart” that can seriously affect heart rhythms and even cause sudden death. The better news being that apparently “once patients stop taking propoxyphene, the risk will go away.”
Consumers with one of these drugs on hand might ask a phamacist for instructions on their disposal, as they are not included in the list of drugs the FDA suggests are OK to flush.
Note: For more information on the factors leading to the FDA decision regarding propoxyphene, and thoughts on the implications for pain patients, see Stewart B Leavitt's commentary at Pain-Topics.org – "Propoxyphene Products Withdrawn in USA. Why?"