What Is Oxycodone?
Oxycodone is one of the most commonly abused prescription medications and can often result in addiction. It is a synthetic opioid analgesic which is a chemically altered form of an extract that originally comes from the Persian or opium poppy, a flower normally grown in the Middle East and parts of Asia. Other opiate analgesics like codeine, morphine, and hydrocodone are also derivatives of chemicals found in the opium plant.
What Is the History of Oxycodone?
Oxycodone was originally developed in the early 1900s in Germany, along with several other opiate analgesics which were intended to be an improvement on the natural extract from the poppy plants. Oxycodone was widely used during World War I as a treatment for postoperative pain in soldiers of the Central Powers led by Germany.
What Is Oxycodone Use To Treat?
Today, oxycodone is often used as an alternative to morphine to treat pain in cancer patients as may have fewer side effects in some patients. Oxycodone is only available in oral tablet formulation in the U.S., both alone and in combination with other ingredients. It is still used as an intravenous (IV) and intramuscular (IM) injection, along with oral formulations in other parts of the world.
Oxycodone is highly effective for the treatment of both acute and chronic pain but is also readily abused and very addictive when taken for non-medical reasons. It works by affecting the “opiate receptors” in the brain and other tissues and in addition to the analgesic activity, can cause other effects including euphoria and relaxation which makes it more likely to be abused.
Over time, people taking oxycodone may develop tolerance to the drug and require larger doses to get the same effect. Especially when used for non-medical effects, this tolerance development will often result in severe withdrawal symptoms if the drug is suddenly discontinued.
What Has the FDA Done To Decrease Oxycodone Abuse?
Due to the increasing prevalence of abuse of oxycodone and other opiate pain relievers, the Food and Drug Administration (FDA) has recently required that new drug formulations include abuse-deterrent mechanisms. These may include the addition of anti-abuse ingredients or specialized release mechanisms which will prevent or increase the difficulty of crushing the medication to filter and inject oxycodone or to “snort” the powder.
In the U.S., oxycodone is available as the only ingredient in both fast-release and controlled-release medications, as well as in combination with aspirin, acetaminophen, or ibuprofen.
Recently, drug manufacturers have been required to include abuse-deterrent mechanisms in new formulations of highly abuse-prone drugs like oxycodone. One of these mechanisms includes the addition of an opiate-blocking medication, naloxone, which blocks the action of oxycodone and may cause withdrawal in people who crush the medication for non-medical reasons related to abuse including IV injections and “snorting”.
- OxyContin – oxycodone sustained release tablet
- Roxicodone, OxyIR – oxycodone immediate-release tablet
- OXAYDO – oxycodone immediate release with abuse-deterrent chemical tablet
- Percodan – oxycodone immediate release with an aspirin tablet
- Percocet, Roxicet, Oxycet – oxycodone immediate release with acetaminophen tablet and solution
- Oxycodone/Ibuprofen – oxycodone immediate release with ibuprofen tablet
- Xartemis XR – oxycodone with acetaminophen sustained release tablet
Because oxycodone is an ingredient in many medications, there are many manufacturers that make drugs containing oxycodone.
- OxyContin is manufactured by Purdue Pharma.
- Roxicodone and Roxicet are manufactured by Xanodyne Pharmaceuticals, Inc.
- OXAYDO is manufactured by Egalet US Inc.
- Percodan and Percocet are manufactured by Endo Pharmaceuticals.
- Xartemis XR is manufactured by Mallinckrodt plc.
Many other companies manufacture ibuprofen and other drugs that use oxycodone as an ingredient.
Oxycodone is a pain reliever that functions by blocking pain signals as they travel down nerves to the brain.
Is Oxycodone FDA-Approved?
Oxycodone received its first FDA approval in December 1995 with the drug Oxycontin. When the FDA approved OxyContin, it was believed that the drug’s controlled-release formulation would result in a lesser potential for abuse. This belief came because OxyContin would be slowly absorbed, so there would be no instant high to encourage abuse.
Because of its high potential for abuse and addiction, oxycodone is categorized at the highest level of controlled substance classification. This category, Schedule II (C-II), indicates that the medication is effective for medicinal use but it has an extremely large possibility to be abused or used for non-medicinal purposes and also poses a great risk of addiction.
Oxycodone is one of the most commonly abused medications available and is responsible for a large percentage of ER visits caused by opiate abuse and overdose. Oxycodone overdose has been the cause of many opiate-related deaths. OxyContin is the most commonly abused drug in this category.
In 1999, there were about 2,700 known overdose deaths caused by opiate medications but by 2011, that number had climbed to nearly 12,000. The rise in opioid emergency room visits and deaths is part of what prompted the FDA to begin requiring that all manufacturers introducing opiate-type pain management drugs develop a Risk Evaluation and Mitigation Strategy (REMS) to manage known or potential serious risks with a drug, including those with a potential for abuse and addiction.
The Drug Enforcement Agency (DEA), in concert with the FDA, has also developed guidelines regarding appropriate pain management practices to limit overprescribing. Many people who abuse and become addicted to oxycodone drugs like OxyContin are not taking their medication but are obtaining it from someone for whom it was prescribed with or without the patient’s knowledge.
Despite medical community and law enforcement attempts to curb the widespread abuse and addiction problems occurring with oxycodone, abuse of the medication continues and overdoses are still on the increase.
In October 2015, President Obama proposed a $1.1 billion program intended to reduce prescription drug and heroin abuse. This program will potentially increase awareness and help to address the mounting opiate addiction epidemic by increasing access to addiction treatment and expanding training programs for medical personnel.
What Is Oxycodone Prescribed To Treat?
Oxycodone is prescribed to alleviate severe pain that is severe enough to warrant opioid treatment. Oxycodone is prescribed when other pain relief medications either did not work well enough or could not be tolerated.
All medications are subject to a number of side effects. When taken appropriately, the side effects of OxyContin and other oxycodone products are predictable and easily managed but when taken in large doses, side effects are potentially severe and even life-threatening. Most side effects are caused by oxycodone’s activity in the brain and central nervous system but other body systems are also affected.
Common side effects of oxycodone include:
- Drowsiness and dizziness
- Anxiety, excitability, and moodiness
- Nausea and vomiting
- Blurred vision and constricted pupils
- Dry mouth
In most cases, for patients who take oxycodone as prescribed, the medication does not cause severe side effects. When taken for non-medical or recreational purposes, particularly in large doses, it may cause severe effects, some of which may be fatal such as:
- Excessive dizziness and sedation
- Severe vomiting
- Loss of consciousness
- Slowed breathing
- Respiratory arrest
Oxycodone may also cause tolerance when the medication is taken for an extended period of time. People who become tolerant of the medication will require larger doses to get the same effects. This is known as dependence. When the drug is taken for non-medical purposes, dependence is also called addiction.
When oxycodone products containing other medications like acetaminophen and aspirin are taken for long periods of time, serious effects may be caused by the additional ingredient. These effects may include liver damage, kidney damage, and bleeding disorders.
If oxycodone is abused, in addition to physical dependence or addiction, psychological addiction may occur. It results in “cravings” or an intense desire for continued use of the medication and may cause other problems. Symptoms of psychological addiction may include:
- Excessive moodiness
- Outbursts of anger
- Chronic anxiety
- Visual disturbance
- Relationship troubles
- Difficulty with employment
When oxycodone is taken for non-medical or recreational purposes, it causes changes in the brain and causes people to become used to “feeling no pain.” They often constantly seek the euphoric effects of oxycodone, leading to a pattern of repeated abuse. If the drug suddenly becomes unavailable or is discontinued, symptoms of opiate withdrawal will occur.
Because oxycodone causes changes to the brain and other body tissues, when the drug is withdrawn, the effects that occur are “opposite” to the drug’s actions. Symptoms of withdrawal may include:
Common symptoms of oxycodone withdrawal include:
- Cold sweats
- Body aches, headache, and backache
- Vomiting and diarrhea
- Severe anxiety or “sense of impending doom”
- Restlessness and insomnia
- Heart palpitations
- Dilation of pupils
- Visual and hearing disturbance
These symptoms can quickly become severe and while the most severe will likely subside over a period of days, some symptoms may remain for several months.
Most people find withdrawal to be one of the worst experiences of their lives. It can be extremely debilitating and painful, and when combined with the intense psychological desire of addiction, withdrawal is very difficult.
In some cases, medical treatments including certain medications can be used to “wean” the patient off of oxycodone and may reduce the most severe symptoms. Addressing the behavioral issues of addiction is also necessary and many people benefit from group or individual therapy or participation in 12-step or other support groups.
The first step in treating oxycodone addiction is recognition of the disease. In some cases, the addict will seek treatment on their own but people who are coerced or even forced into treatment can see success as well. In most cases, close supervision of the withdrawal and treatment process is required to avoid relapse and ensure that recovery is possible.
Many of the thousands of overdose deaths caused by opiates have been a result of oxycodone, specifically OxyContin. OxyContin prescriptions for non-cancer pain increased by more than 1000% between 1997 and 2002.
In 2010, the FDA forced Purdue Pharma to reformulate OxyContin so that it would be more difficult to abuse. The new controlled release mechanism makes it so that the pills cannot be easily crushed or dissolved. This has reduced the potential for injection including IV use and has prevented “snorting” of the medication, but many people continue to abuse the drug through the oral route.
The State of Kentucky has been one of the worst areas affected by OxyContin abuse. The state, along with one of its hardest hit areas, Pike County, also sued Purdue Pharma with claims that the company misled consumers, medical professionals, and the government about the risk of abuse and addiction and promoted the medication for a wide range of injuries that did not cause severe pain. As a part of the marketing programs, “starter coupons” and promotional items like fishing hats and plush toys were given to patients. The lawsuit claims that marketing practices caused OxyContin to be “excessively overprescribed”.
A survey taken in Pike County indicated that seven in 10 people believed that OxyContin had devastated the lives of local residents. Many OxyContin prescriptions were paid for by social service programs and prescribing was so prevalent that the medication was termed “Hillbilly Heroin”. The eastern Kentucky anti-drug group, Operation UNITE, claims that OxyContin made many people who were not drug users into addicts.
The lawsuit seeks $1 billion in damages to reimburse the Kentucky state government for social services, healthcare, and other costs. Purdue offered a settlement of $500 million but the state refused. Purdue subsequently had the case moved to federal court in New York but it was returned to Pike County, Kentucky and additional requests by Purdue have been denied. Pike County did settle out of court, but the state’s lawsuit has not been resolved, even though it has been drawn out for more than seven years.
In 2007, the manufacturer of OxyContin, Purdue Pharma, and three executives settled charges relating to the illegal marketing of its medication. The settlement of $635 million was for federal charges but the State of Kentucky has been the worst area affected by Purdue’s misleading advertising to medical professionals which has resulted in an epidemic of abuse, addiction, and overdose.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.