Drug Profile

Propoxyphene (DARVON, DARVOCET-N) is a narcotic that relieves mild to moderate pain. We have listed this drug as Do Not Use for years because it is no more effective than aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN) or codeine, and it is much more dangerous than aspirin. Public Citizen first petitioned the government in 1978 to remove this dangerous drug from the market.[1]

If you have taken aspirin for your pain and it has not worked, propoxyphene will probably not do any better.[2] In fact, some found that propoxyphene by itself is no more effective than a sugar pill (placebo).[3] Most studies show that propoxyphene is less effective than aspirin and that it has a potential for addiction and overdose.

Propoxyphene has remained on a list of drugs for years that are inappropriate for use in older adults.[4] Unfortunately, it is still being widely prescribed to elderly patients. In 1998, among Medicare beneficiaries, 6.8% of those living at home were receiving propoxyphene, and 15.5% of those who were institutionalized were prescribed propoxyphene.[5]

In 2012, Public Citizen filed a petition with the FDA requesting changes in the drug labeling for opioid pain medications in an effort to prevent overprescribing of these medications. The petition states that opioid labels are especially broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Currently, the labels on opioid analgesics simply state that they are approved for moderate to severe pain. The petition calls for striking the term “moderate,” inserting a suggested duration of use and adding a suggested maximum dose equivalent of 100 milligrams of morphine. The requested changes relate only to opioids used for noncancer pain.

If the requested changes are adopted, drug companies no longer would be able to promote these pain medications as safe and effective for long-term use by noncancer patients.[6]

Regulatory actions surrounding propoxyphene

2003: In Switzerland, the last product containing dextropropoxyphene was withdrawn on December 31.[7]

2005: On January 31, the U.K. equivalent of the FDA announced that the combination painkiller containing propoxyphene and acetaminophen would be removed from the market within one year.[8] This decision was based on the fact that it is a poor pain reliever and that the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.

In May 2005, the Swedish regulatory agency announced that it would withdraw fixed-dose dextropropoxyphene combinations from its market by autumn 2005.

2006: Public Citizen's Health Research Group again petitioned the FDA (as we had previously done in 1978) to immediately begin phasing out the sale of the dangerous painkiller propoxyphene (DARVON)[9]. There are many generic versions of propoxyphene on the market, as well as a number of products that combine propoxyphene with acetaminophen (TYLENOL). These products are sold as DARVOCET and also are widely sold as generic drugs. A phased withdrawal, instead of an immediate ban, is necessary because of the addicting properties of the drug and the need to switch patients to other painkillers.[10]

2009: The FDA denied our petition but made a decision to require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

This decision was made in response to the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The FDA will continue to assess propoxyphene-containing products and look into its prescribing and use in the elderly.[11]

Public Citizen's Health Research Group had petitioned the FDA to reconsider its denial of our petition to ban propoxyphene, which has now been banned in the UK and in the European Union. This petition is supported by Dr. Donald Kennedy and Dr. Richard Crout, the FDA Commissioner and Director of the Center for Drugs in the FDA 30 years ago when the FDA first denied our petition to ban propoxyphene.

In 2009, the FDA updated the safety labeling information of propoxyphene-containing products. The updated information addressed the risk of overdose and the potential to affect cardiovascular events. The cardiovascular events referred to in the labeling change included life-threatening arrhythmias.[12]

2010: The FDA banned propoxyphene. The agency says it was prompted to act because of new proof of adverse heart effects in studies of healthy people taking normal doses of the drug.