Pill Pushing©

The Best of Pill Pushing - Darvon: Addiction, suicide and heart problems - (8/16/2017)

Pill Pushing
The ways in which medications have changed our culture
Ron Gasbarro, PharmD

The drug: Darvon (propoxyphene)
 
Society at the time: The year was 1957. What happened then? The Wham-O Company produced the first Frisbee. Elvis Presley appeared on The Ed Sullivan Show from the waist up because of his provocative and scandalous hip swiveling. Paul McCartney met John Lennon for the first time. Sputnik I was launched by Russia, officially kicking off The Space Race. Christian Dior died; Caroline Kennedy was born. And the pain reliever Darvon was first marketed in the US. 
 
The good, the bad, and/or the ugly:  Darvon and its counterpart Darvocet-N, which contained acetaminophen, were opioid analgesics (narcotics) manufactured by Eli Lilly and Company. They were intended to treat mild pain and also had antitussive (cough suppressant) effects. They were taken off the US market in 2010.
 
Medicinally, the drug had been primarily used for pain management. The popularity of Darvon was due to its high rate of effectiveness when administered for managing pain. However, because the substance is partially comprised of opium, its use put the patient at a high risk for dependency and addiction. 
 
According to the US Department of Justice’s Drug Enforcement Agency, Darvon is a close relative of methadone, a drug commonly used to treat addiction to opiates such as heroin [DEA, 2015]. Oral analgesic potency was about half that of codeine, and about as strong as two adult aspirin tablets. At the height of its popularity, over 100 tons of propoxyphene was produced in the United States each year to cover the 30-plus million prescriptions written for the products. Even though it was a narcotic, the FDA, under the Controlled Substances Act, christened it a mere Schedule 4 drug, whereas other narcotics like Vicodin and Percocet were deemed Schedule 2 drugs, making them far more difficult to obtain from prescribers.  
 
The impact of the drug on society: Over the last few decades, drug use in the United States has skyrocketed. The rate of prescription drug abuse has also increased substantially. Several cultural factors have contributed to this increase and have affected the use of Darvon. According to the website darvonabusetreatment.com, these factors include the following: [darvonabusetreatment.com, 2015]
Stress. Bill, 40, was having a difficult time at work. The pressure was unbearable. So, when he got home, he made a couple of martinis and took two of his wife’s Darvon capsules. 
o Whether it is work, school, or coping with our day-to-day activities, stress and anxiety of our hectic lives can play a big role in drug abuse. If an individual is anxious or stressed out, he or she may turn to drugs to escape or relax.
Peer pressure. Mindy, 17, liked getting high. She had tried marijuana and cocaine but she felt somewhat out of control when she used them. Her friend, Cindy, also 17, offered her a Darvon capsule as a “safer” way to feel good. “My mom takes them all the time so they must be safe,” Cindy told Mindy. 
o Darvon was a commonly abused drug among teenagers. Because it was a prescription medication, many adolescents thought that it is safer to use than other illegal drugs. If someone is surrounded by friends that abuse Darvon, that individual is more likely to use that.
Availability. Sam, 35, missed Darvocet-N when it was taken off the market in 2010. A buddy told him you can still get it online. Sam was pleased to be able to obtain a drug he liked very much. 
o While Darvon is no longer available in the US, prior to 2010 it was commonly prescribed and fairly easy to obtain. Although prescriptions are no longer available, the drug can still be purchased through illegal channels.
Media. Shelly, 23, was a big fan of a certain music star. When this pop idol admitted to a TV talk show host that she had been hooked on Darvon, she looked terrific and made it seem easy to kick the habit. “And she is rich,” reasoned Shelly, who immediately sought out the drug via friends.  
o The media plays an enormous role in drug abuse. Many movies and television shows focus on and even glorify illicit drug use. In addition, many celebrities who are often idolized by members of society have confessed to abusing drugs and have made addiction more acceptable.
Environment. Bill, 14, lives in the projects and is generally bored, often skipping school. Pat, also 14, is from an upper middle-class family and is also tired of his life. Both boys were able to score Darvon: Bill got his on the streets and Bob obtained his at the parties of friends. 
o Where an individual lives and who he or she associates with can significantly impact the decisions that he or she makes. If someone is surrounded by others who abuse prescription drugs or if someone frequents places (clubs, parties, etc.) where prescription drug use is common, that person is more likely to try using drugs such as Darvon.
 
High toxicity and relatively easy availability made propoxyphene a drug of choice for right-to-die societies. It is listed in Drs. Philip Nitschke and Fiona Stewart’s The Peaceful Pill Handbook as well as in Dr. Pieter Admiraal's Guide to a Humane Self-Chosen Death. Said the authors of The Peaceful Pill Handbook, “With the withdrawal of most barbiturates from the market, propoxyphene has become the most common doctor-prescribed medication used by seriously ill people to end their lives." The slang name for the combination of propoxyphene and other drugs used for suicide is "Darvon cocktail".
 
Where the drug is today: Due to the drug’s potential for abuse, the United States FDA took Europe’s lead and pulled Darvon and Darvocet-N from the market in 2010. An estimated 10 million patients were prescribed some form of propoxyphene and the United States Drug Enforcement Agency named Darvon one of the country’s top ten abused drugs, based on reports made by medical examiners who investigated drug abuse deaths.
 
In addition, clinical data published at the same time revealed that the drug could potentially put patients at risk for serious or even fatal heart rhythm abnormalities prompting regulators to act. Fatality in overdose is a major concern for all opioid analgesics, given that patients often take higher than therapeutic doses either by accident or on purpose [Paulozzi, 2006; Okie, 2010]. There are two factors that suggest Darvon might have a greater overdose danger than other opioids. First, various reports from emergency departments and poison control centers have reported that patients who overdosed on propoxyphene frequently died rapidly, often within one hour [Hawton, 2004; Jang, 2011]. Second, a Scottish study revealed that the estimated ratio of fatal overdoses to total prescriptions written was greater for propoxyphene than for either codeine or another narcotic, dihydrocodeine [Afshari, 2005]. The rapidity of death in many reported cases of propoxyphene overdose suggested a possible cardiovascular mechanism. A study of 222 patients presenting with overdose to a single intensive care unit found 41% had ECG abnormalities as well as various other heart rhythm problems [Madsen, 1984]. The cardiac data was the final nail in the coffin for propoxyphene, as that information significantly altered that drug’s risk-benefit profile," The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks. Although Darvon is no longer marketed, it remains necessary to determine study how the drug affects the heart, information that may save lives in the event of other types of narcotic overdose.  
 
Thus far, removing Darvon products from the market has done little to stifle the abuse to other drugs. A study of the medical records of over 24,000 persons who were in the Veterans Administration showed that the withdrawal of propoxyphene-containing products resulted in rapid and virtually complete elimination in propoxyphene prescribing in the veterans population; however, nearly 90% of regular users of propoxyphene switched to an alternate opioid, and 75% continued to use opioids chronically [Hayes, 2015]. 
 
 
References
Admiraal P.  Guide to a Humane Self-Chosen Death. Delft, The Netherlands: WOZZ Foundation; 2006. 
 
Afshari R, Good AM, Maxwell SRJ, Bateman DN. Co-proxamol overdose is associated with a 10-fold excess mortality compared with other paracetamol combination analgesics. Br J Clin Pharmac. 2005;60:444–7.
 
Darvon Abuse Treatment. Available at: http://www.darvonabusetreatment.com/how-culture-influences-darvon-abuse  
 
Hawton K, Simkin S, Gunson K, et al. A multicentre study of coproxamol poisoning suicides based on coroners’ records in England. Br J Clin Pharmac. 2004;59:207–12.
 
Hayes CJ, Hudson TJ, Phillips MM, et al. The influence of propoxyphene withdrawal on opioid use in veterans. Pharmacoepidemiol Drug Saf. 2015 Aug 6. doi: 10.1002/pds.3851. [Epub ahead of print]
 
Jang DH, Hoffman RS, Nelson LS, Chu J, Bhanot K, Bagley W. Fatal outcome of a propoxyphene/acetaminophen (Darvocet) overdose: Should it still be used in the United States? Ann Emerg Med. 2011;57:421–2.
 
Madsen PS, Strom J, Reiz S, Sorensen MB. Acute propoxyphene self-poisoning in 222 consecutive patients. Acta Anaesthesiol Scand. 1984;28:661–5.
 
Nitschke P, Stewart F. The Peaceful Pill Handbook. Waterford, MI: Exit International US Ltd; 2010. 
 
Okie S. A flood of opioids, a rising ride of deaths. N Engl J Med. 2010;363:1981–5.
 
Paulozzi L, Ryan GW. Opioid analgesics and rates of fatal drug poisoning in the United States. Am J Prev Med. 2006;31:506–11. 
 
US Drug Enforcement Administration. Drug fact sheets. Propoxyphene. Available at: http://www.dea.gov/druginfo/concern_dextro.shtml  
 
US Food and Drug Administration. Xanodyne agrees to withdraw propoxyphene from the US market [press release]; November 19, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm    
 


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