In collaboration with Health Canada, Paladin Labs Inc. has decided to voluntarily recall and withdraw all lots of Darvon-N (dextropropoxyphene, also known as propoxyphene) on the Canadian market and discontinue the sale of the product. This decision follows a United States Food and Drug Administration (FDA) request that all manufacturers of propoxyphene, an opioid pain reliever used to treat mild to moderate pain, withdraw their products from the US market The withdrawal is based on all available data, including data from a new study that evaluated the effects of increasing doses of dextropropoxyphene on the heart.
Results of a new study show that, even at doses normally taken to manage pain, dextropropoxyphene can significantly increase the risk of serious abnormal heart rhythms. This can be important in elderly patients and those with kidney problems as they may be more likely to experience the heart rhythm effects of dextropropoxyphene. Patients are asked to talk to their healthcare professional about discontinuing Darvon-N and switching to alternative pain medicines. Any unused tablets should be returned to their point of purchase for disposal.
If you currently take Darvon-N, you should: Talk to your healthcare professional if you have any concerns about Darvon-N. Contact your healthcare professional right away if you experience an abnormal heart rate or rhythm or other symptoms including dizziness, light headedness, fainting or heart palpitations. Report any side effects with Darvon-N to Paladin Labs Inc. or to the Canada Vigilance program.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious heart rhythm abnormalities or other serious or unexpected adverse reactions in patients receiving Darvon-N should be reported to Paladin Labs Inc. or Health Canada.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products.