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British To Ban The Combination Painkiller Containing Propoxyphene With Acetaminophen

Worst Pills, Best Pills Newsletter article April, 2005

The Committee on the Safety of Medicines (CSM), the British counterpart to the U.S. Food and Drug Administration (FDA), announced on Jan. 31, 2005 that the combination painkiller containing propoxyphene with acetaminophen will be banned from the market within one year. A commonly prescribed version of this drug is sold in the U.S. as DARVOCET. The decision to remove this drug from the market is based on the fact that it is a poor pain reliever and that the risk of toxicity in overdose, both...

The Committee on the Safety of Medicines (CSM), the British counterpart to the U.S. Food and Drug Administration (FDA), announced on Jan. 31, 2005 that the combination painkiller containing propoxyphene with acetaminophen will be banned from the market within one year. A commonly prescribed version of this drug is sold in the U.S. as DARVOCET. The decision to remove this drug from the market is 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.

The CSM estimates that each year there are 300-400 deaths following deliberate or accidental overdose involving the propoxyphene with acetaminophen combination in England and Wales alone. Approximately one-fifth of these deaths are considered to be accidental. Combination with alcohol or other central nervous system depressants is particularly hazardous. A small multiple of the recommended dose even without alcohol may cause fatal respiratory depression or heart rhythm disturbances.

The CSM made the following points:

  • In relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal dose and some of the fatalities are caused by inadvertent overdose. A drug interaction with alcohol increases the risk for fatal toxicity.
  • There is no strong evidence that effectiveness of this combination product is superior to full strength acetaminophen alone with either acute or chronic use.
  • It has not been possible to identify any patient group in whom the benefits outweigh the harm.
  • Propoxyphene with acetaminophen products should be withdrawn altogether over the next 6-12 months.

The Health Research Group petitioned the government in 1978 to remove propoxyphene from the market. Propoxyphene, alone or in combination, has been listed as DO NOT USE since the publication of our first edition of Worst Pills, Best Pills in 1988.

Propoxyphene has been included for years on a list of drugs that are inappropriate for use in older adults. Unfortunately, it is still being widely prescribed to elderly patients. In 2003, more than 24 million prescriptions were dispensed for propoxyphene with acetaminophen in the U.S.

What You Can Do

There is no medical reason that you should be taking a propoxyphene-containing product when there are a number of safer drugs on the market to manage mild to moderate pain.

  CURRENT 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.

Disclaimer

The information on this website is not intended to substitute for professional medical advice, diagnosis, or treatment. Consult your doctor before changing or discontinuing any medication.