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The first 100 deaths caused by propoxyphene and recorded by the Chief Medical Examiner of North Carolina were studied. Victims ranged evenly in age from the second to the seventh decade. Over 65% were suicides with a female to male ratio of 2:1. Blood propoxyphene concentrations of 0.2 mg/dl were fatal, representing rapid ingestion of approximately ten capsules. In North Carolina, deaths due to propoxyphene have increased from five in 1969 to 49 in 1975. Raising physician-awareness of propoxyphene's toxicity and placing the drug in Schedule II are two of the author's recommendations for reducing the number of propoxyphene deaths.

Of 81 fatal overdoses of propoxyphene identified over a ten-year period, suicide accounted for 76.5% and accidents for 23.5%. The incidence sharply increased in 1973 and the death rate has remained constant since then. In two thirds of the suicidal overdose deaths, additional drugs were encountered. Alcohol was detected in an additional 15%, and propoxyphene preparations alone were used in 19%. In the 19 deaths from accidental overdose, six resulted from recreational abuse, and additional drugs were detected in all. Five who dief of propoxyphene preparations alone had significant medical illnesses. Eight nonrecreational users died after taking other drugs or alcohol along with propoxyphene. Only one individual in the entire series was found to be dependent on propoxyphene. Although propoxyphene cannot be regarded as a harmless drug, the study indicates a very low rate of dependency and a low potential for recreational abuse. As with other drugs, adequate warnings concerning dosage abuse and the concurrent use of alcohol and other drugs must be stressed. The suggestion to reclassify propoxyphene to a Schedule II drug does not appear justified.

This survey continues and expands earlier studies (Finkle et al., 1976a, b). A total of 27 medical examiner or coroner offices across the USA and Canada were visited. The combined jurisdictional population of these 27 sites is 64.8 million people: 56.5 million people in the USA (27% of the US population) and 8.3 million in Canada (Ontario). Since 1969 through mid-1983, a total of 4412 cases provided information sufficient for inclusion in this study. In each of the cases the presence of propoxyphene, and often its major metabolite, in the blood or tissues of the deceased was confirmed by toxicological analysis at the survey site. The following is a summary of the survey findings: The incidence of propoxyphene-associated deaths reached a peak in 1977, then declined by 22.2% from 1977 to 1978 and by 33.3% from 1978 to 1979, and by a further 10-18% since then. This continuing decline has occurred despite increased interest in propoxyphene misuse and the existence of improved analytical methods for the detection of propoxyphene and its metabolites. The decline is greater than can be accounted for by the decline in propoxyphene prescribing. The most common manner of death was suicide, accounting for about 45% of the cases; it can be safely assumed that the suicides were under-reported. A large majority of the suicides involving propoxyphene were multiple-drug intoxications, including alcohol. Propoxyphene alone was noted in about one-sixth of the suicides. These findings confirm those of the earlier studies, i.e., that a high proportion of the deaths associated with propoxyphene are suicides, and, in most cases, the deceased were victims of multiple-drug toxicity. More than 90% of cases involved persons between the ages of 20 and 40 years. There were very few instances of paediatric, adolescent or older adult deaths associated with propoxyphene. There is no evidence to support the view that the deceased were part of the street drug-abuse population. A history of heroin abuse appeared in less than 5% of the cases. Even fewer people had been known to have abused propoxyphene before their deaths, but 18% of the population had been known to 'self-medicate', using multiple drugs without appropriate medical supervision. The distribution of males to females approximated that of the US population.(ABSTRACT TRUNCATED AT 400 WORDS)

We analyzed trends in prescribing and overdose deaths related to propoxyphene (e.g., Darvon) before and after a 1978-80 informational campaign carried out by the US Food and Drug Administration and the drug's manufacturer through mailed warnings, face-to-face education of prescribers, press releases, and labeling changes. The goals included a reduction in propoxyphene use with alcohol or other CNS depressants, reduced prescribing of refills, and cessation of prescribing for patients at risk of abuse and misuse (suicide). We conducted time-series analyses of nationwide propoxyphene use data 1974-83 and analyzed data on drug overdose death rates covering a combined population of about 83 million. Segmented regression methods were used to determine if the informational program was associated with changes in trends of prescribing or overdose deaths. Comparison drug series were analyzed to control for other secular trends in prescribing. Nationwide propoxyphene use during the warnings continued a pre-existing decline of about 8 per cent per year, but this decline halted after the warnings. The no-refill recommendation had no impact on refill rates. The risk of overdose death per propoxyphene prescription filled has remained about constant since 1979. Sharper declines in misuse of such drugs will require stronger, more sustained regulatory or educational measures.

Eighteen medical examiners, coroners, and forensic science laboratories and offices, representing a total jurisdictional population of 52.6 million, were visited during November 1975, and more than 1200 cases occurring in the four years from 1972 through 31 July 1975 were evaluated for inclusion in the study. The sites were distributed across the United States and Ontario, Canada, and included urban and rural, states, city, and county jurisdictions. Scientific data and circumstantial information was gathered consistently for each case and site by means of five questionnaires. Finally, 1022 cases were compiled and examined, and the data were analyzed to form the body of data from which this report is written. The following conclusions may be drawn. 1. The number of deaths involving propoxyphene is increasing each year, and at a faster rate than total drug deaths. The absolute numbers and rate are different in urban and rural areas, but the frequency reached 6.0 deaths per million population in 1974. Deaths attributed to suicide as well as those determined to be accidental deaths and undetermined have increased. 2. Approximately 66% of all the cases studied had the word propoxyphene included in the cause of death statement on the death certificate. Approximately 46% of the cases were classified as suicide (64% of them female and 36% male), 26% as accidents, and 21% as undetermined. 3. The deceased were mainly middle-class, Caucasian, urban dwellers, with male and female evenly distributed. Their ages were from 20 to 50 years, with few outside this range. Female ages were uniformly distributed, but males in their early twenties were very prominent. This is different from the U.S. population age distribution, which is currently dominated by teenagers. Propoxyphene does not appear to be a pediatric problem, as seen in the study. 4. The deceased were not part of the illegal drug abuse population and had no particular propensity for the use of heroin or narcotics, but rather they were a particular medical population of those who misuse prescription drugs and alcohol. 5. The deceased did have a marked tendency to hypochondria, chronic minor illnesses and emotional problems. Some 43% had recent medical histories, and 82% had a documented psychiatric history which often included (51%) self-destructuve behavior such as suicide attempts. Almost all received a wide range of prescription drugs, particularly tranquilizers, which they often misused in the sense of self-medicating, multiple drug ingestion, and combining alcohol with their medication. Approximately 34% had a history of misusing some drug, and 20% could be defined as abusers in that they were prone to excessive use of their medications; 44% had diazepam available to them, and 17% were either problem drinkers or alcoholics.