What is Propoxyphene?

Propoxyphene has been banned for medical use in the United States due to the adverse effects it was having on the hearts of patients. The FDA recommends against any continued use of propoxyphene.
Evidence Based
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Propoxyphene (also called dextropropoxyphene) is an opioid pain reliever that was used to treat mild to moderate pain. It was also used as a cough suppressant. It is manufactured by Xanodyne Pharmaceuticals under the brand names Darvon or Darvon-N (propoxyphene alone) or Darvocet, which is a combination of the drug and acetaminophen (Tylenol).

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Darvon is manufactured in 65 milligram (mg) capsules containing the drug in powder form with other inactive ingredients. Darvocet comes in tablet form in two different formulations:

  • Darvocet-N 50 — this form of the drug contains 50 mg propoxyphene napsylate and 325 mg acetaminophen
  • Darvocet-N 100 — this forms of the drug contains 100 mg propoxyphene napsylate and 650 mg acetaminophen

In December 2010, the Food and Drug Administration (FDA) removed propoxyphene-containing products from the United States market due to its effects on heart health. A multiple-ascending dose (MAD) study was completed comparing healthy volunteers who took 600 mg or 900 mg of propoxyphene for 11 days. At the conclusion of the study, electrocardiogram (EKG) readings were taken, where dangerous effects on the heart were observed.

Doctors have stopped prescribing propoxyphene in favor of other pain medications. Other prescription drugs such as codeine and hydrocodone are now used for pain management and pain relief.

A study from 2018 found that about 10.3 million people (12 and older) have misused opioids in the past year. This is about 3.7 percent of the U.S. population.

National Survey on Drug Use and Health (NSDUH)
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Propoxyphene Side Effects

The most common side effects of propoxyphene use include:

  • Sedation
  • Nausea/vomiting
  • Constipation
  • Skin rashes
  • Weakness
  • Dizziness
  • Abdominal pain
  • Lightheadedness
  • Euphoria
  • Hallucinations/visual disturbances

More severe and dangerous adverse effects reported include:

  • Cardiac arrest
  • Abnormal heart rhythm
  • Coma
  • Suicide
  • Respiratory arrest
  • Convulsions
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Risks of Propoxyphene

Propoxyphene is classified as a Schedule IV drug by the Drug Enforcement Administration. These drugs have a low potential for abuse and low risk of dependence.

Additionally, there is a risk of severe hypotension (low blood pressure) when taking propoxyphene. This can be especially dangerous in patients who have difficulty maintaining blood pressure or those who have low blood volume.

If you have a head injury, do not take propoxyphene, as it can elevate the pressure of cerebrospinal fluid. This elevation may become exaggerated with a head injury and can become dangerous.

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If you are pregnant, plan on becoming pregnant, or breastfeeding, do not use propoxyphene. The drug passes through breast milk and can have negative effects on a nursing child.

Two pills mixing equals dangerous

Drug Interactions

Propoxyphene is a central nervous system (CNS) depressant, which works by slowing down the body’s systems. It should not be combined with other CNS depressants, including:

  • Antidepressants (Monoamine oxidase inhibitors)
  • Sedatives
  • Tranquilizers
  • Muscle relaxants
  • Opioids and opiates
  • Barbiturates

CNS depressants should not be mixed with alcohol because their effects can become worse when combined. As a result, severe respiratory depression and death can occur.

Propoxyphene is metabolized by the enzyme CPY3A4, which plays a role in breaking down other medications and food. Do not consume grapefruit while taking the drug, and check with your doctor about other medicines that may cause problems.

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Addiction Symptoms

Propoxyphene can be addictive. Using the drug may eventually lead to physical dependence, psychological dependence, and abuse. The drug is an opioid agonist, which means it binds to the opioid receptors in the brain and blocks the sensation of pain. Opioids induce feelings of calm and euphoria, which can become addictive very quickly.

Addiction is characterized by a set of behaviors surrounding drug use. Someone who is addicted to propoxyphene might be unable to stop using it, may continue to do so despite knowing it is harmful, and may have cravings when not taking it.

Signs of opioid addiction and abuse include:

  • Drowsiness
  • Changes in sleep patterns
  • Frequent flu-like symptoms
  • Changes in exercise habits
  • Money problems
  • Lack of hygiene
  • Isolation from family or friends
  • Weight loss
  • Decreased libido
  • Stealing from family, friends, or businesses
  • Associating with people who encourage addiction
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Overdose and Withdrawal

Overdoses from opioids can happen for many reasons, including:

  • Mixing opioids with other CNS depressant medications, painkillers, alcohol, or illicit drugs
  • Taking opioids without a prescription
  • Taking opioids in order to get high
  • Using more of an opioid than is prescribed (intentionally or accidentally)

Opioids, such as propoxyphene, cause respiratory depression (slow and ineffective breathing), which is extremely dangerous. High doses of the drug act on the brain stem, and affect breathing rate and rhythm. Most often, this effect is seen in opioid overdoses, or when too much of the drug is taken in a single dose. Other signs of propoxyphene overdose include:

  • Limp body
  • Purple/blue lips and fingernails
  • Vomiting
  • Pale and clammy skin
  • Unable to wake or speak

If any of these symptoms are observed, call emergency medical services immediately and take naloxone, if available.

If someone uses an opioid drug for an extended period of time, they become physically and psychologically dependent on it. In short, this means they need to take the drug in order to feel normal and function daily. When drug use is stopped suddenly during dependence, withdrawal syndrome can occur. Symptoms of withdrawal from propoxyphene include:

  • Increased pain
  • Irritability or agitation
  • Anxiety or restlessness
  • Nausea and vomiting
  • Diarrhea
  • Difficulty sleeping
  • Muscle cramps and aches
  • Yawning
  • Watery eyes, runny nose
  • Chills, sweating, or goosebumps
  • Stomach cramps
  • Changes in blood pressure
  • Suicidal thoughts
  • Rapid heart rate

Do not attempt to withdraw from propoxyphene on your own, as this can be extremely dangerous. The sudden change in drug use can cause seizures, and in some severe cases, death.

Furthermore, Darvocet contains acetaminophen, and it is possible to overdose on it as well. This results in liver damage that can potentially be fatal. Signs of an acetaminophen overdose include:

  • Nausea and vomiting
  • Abdominal pain
  • General discomfort or unease
  • Increased sweating

Talk with your doctor about quitting opioid use, and develop a plan on how to do so.

One supervised method of stopping propoxyphene use is tapering off the drug. This process reduces the dosing slowly over a period of time to prevent shock to the body’s systems. In doing so, withdrawal symptoms will be much less severe and can be managed with other medication. In order to ensure safety, tapering should only be done under the direction of your doctor.

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Addiction Treatment Options

The safest way to stop using a drug is under the care of a medical professional. There are many treatment options available for you or a loved one to overcome addiction to opioids.

Medication assisted treatment (MAT) combines drugs such as buprenorphine, naltrexone, and methadone with therapy to provide a “whole patient” approach.

Different programs and counseling options help facilitate lifestyle changes and thoughts around drug abuse. Common options include:

  • Individual counseling— this type of counseling includes one-on-one sessions focused around goal setting and discussions on recovery and progress. It can include specific types of therapy, including:
  • Group counseling— these classes encourage conversation and allow you to learn from one another. Group members often share similar experiences, which can help you feel like you are not alone
  • Family counseling— this form of counseling helps repair and improve family relationships by including participation from spouses, partners, and other family members

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Drug Enforcement Administration. “Drug Scheduling.” DEA, https://www.dea.gov/drug-scheduling

Food and Drug Administration. “Darvocet-N 50 and Darvocet-N 100 (Propoxyphene napsylate and acetaminophen tablets, USP.)” FDA, https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/Darvocet-N_July2009.pdf

Food and Drug Administration. “Darvon.” FDA, Feb. 2018, https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf

Food and Drug Administration. “FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene.” FDA, Nov. 2010, https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-recommends-against-continued-use-propoxyphene

Johns Hopkins Medicine. “Signs of Opioid Abuse.” Johns Hopkins Medicine, https://www.hopkinsmedicine.org/opioids/signs-of-opioid-abuse.html

Mayo Clinic. “Tapering off opioids: When and How.” Mayo Clinic, Feb. 2020, https://www.mayoclinic.org/diseases-conditions/prescription-drug-abuse/in-depth/tapering-off-opioids-when-and-how/art-20386036

MedlinePlus. “Opioid Misuse and Addiction Treatment.” MedlinePlus, Aug. 2018, https://medlineplus.gov/opioidmisuseandaddictiontreatment.html

MedlinePlus. “Opioid Overdose.” MedlinePlus, Dec. 2019, https://medlineplus.gov/opioidoverdose.html.

National Institute on Drug Abuse. “Effective Treatments for Opioid Addiction.” NIDA, Nov. 2016, https://www.drugabuse.gov/publications/effective-treatments-opioid-addiction/effective-treatments-opioid-addiction

National Institute on Drug Abuse. “Prescription Opioids.” NIDA, Jun. 2019, https://www.drugabuse.gov/publications/drugfacts/prescription-opioids

Substance Abuse and Mental Health Services Administration. “2018 National Survey on Drug Use and Health Annual National Report.” SAMHSA, Aug. 2019, https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf

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Updated on: August 5, 2020
Addiction Group Staff
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