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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: propoxyphene (proe POX i feen)
Brand name(s): DARVON, DARVON-N
GENERIC: not available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: propoxyphene and acetaminophen (proe POX i feen and a seat a MEE noe fen)
Brand name(s): DARVOCET-N, PROPOXACET-N, WYGESIC
GENERIC: not available FAMILIES: Non-Narcotic Painkillers, Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: propoxyphene, aspirin and caffeine (proe POX i feen, AS pir in, and kaf EEN)
Brand name(s): DARVON COMPOUND, DARVON COMPOUND-65
GENERIC: not available FAMILIES: Opiate-containing Painkillers, Salicylates
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See Narcotics.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

  • Do not prescribe propoxyphene for patients who are suicidal or addiction-prone.
  • Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.
  • Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.

Propoxyphene products, in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug related deaths. Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes). Propoxyphene should not be taken in doses higher than those recommended by the physician. The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs. Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.

One hazard of taking these drugs continuously for longer than several weeks is drug-induced dependence. Do not stop taking your drug suddenly. With the help of your doctor, work out a schedule for slowly lowering the amount of the drug you take by about 5 to 10 percent each day. Keep a written record of the dosage reduction schedule with you. These steps will make it much easier to become drug free without developing distressing symptoms of drug withdrawal.

These drugs can increase the risk of hip fracture.

Warning

There have been a number of case reports of liver damage involving a possible drug interaction between isoniazid, a medication used to prevent and treat tuberculosis (TB), and acetaminophen, an over-the-counter painkiller and the active ingredient in Tylenol. Isoniazid alone, especially as people get older, has been documented to cause liver damage. Acetaminophen, alone in large doses or probably in combination with alcohol, also increases the risk of liver damage. The combination of acetaminophen with isoniazid, according to the authors of these case reports, may also be dangerous.

If you are taking isoniazid for tuberculosis or have a positive TB skin test and are using the drug, consult your physician before using acetaminophen or any combination product containing acetaminophen. Discuss alternatives to acetaminophen with your physician.

Facts About This Drug [top]

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...

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.

last reviewed February 28, 2021