Millions of people suffer from untreated pain for a variety of illnesses and ailments. In fact, since 1986, the World Health Organization (WHO) has stated that inadequate treatment of cancer and non-cancer pain is a serious public health concern.
Therefore, in the face of this knowledge, the Food and Drug Administration (FDA) approved a new, controlled release pain reliever in 1995 called Oxycontin.
Oxycontin (Oxycodone HCI controlled-release) is the brand name of a drug that contains the opioid Oxycodone, a very strong narcotic pain reliever with twice the potency of morphine. By 2001, Oxycontin was the most widely prescribed brand name narcotic pain medication, with sales exceeding $ 1 billion annually. Originally prescribed to help treat the pain associated with cancer, Oxycontin was designed to slowly release Oxycodone over time, allowing patients to use it twice daily and to retain steady relief.
The opioid quality of Oxycontin works to relieve pain by attaching to specific proteins called opioid receptors, which are found in the brain, spinal cord, and gastrointestinal tract. When these drugs attach to the opioid receptors in the brain and spinal cord they can effectively block the transmission of pain messages to the brain.
However, due to the potency of the drug, if large amounts of oxycodone are released from the tablet all at once, there is potential for a dangerous or fatal drug overdose.
Pharmacological effects of opioid agonists, including Oxycontin, are:
* Anxiolysis (a drug-induced state where patients respond normally to verbal commands). While coordination and cognitive function may be impaired, other functions remain unaffected).
* Euphoria.
* Feelings of relaxation.
* Respiratory depression.
* Constipation.
* Miosis.
* Cough suppression.
Adverse effects of opioid agonists and Oxycontin include:
* Nausea.
* Vomiting.
* Central nervous system (CNS) effects.
* Respiratory depression.
In addition, according to the Drug Enforcement Agency (DEA), abuse of Oxycontin is associated with serious consequences including addiction, overdose and death. The FDA states the potential dangers associated with Oxycontin and, while it is approved for use, has classified Oxycontin as a schedule II controlled substance under the Controlled Substance Act of 1970 because it has a high potential for abuse and can lead to psychological and/or physical dependence. Schedule II drugs have the highest potential for abuse of any approved drugs.
In early 2000, reports of improper and illicit use of Oxycontin surfaced. Some of these reported cases have been associated with serious consequences including death. Oxycontin, as with any prescription narcotic, carries with it some risk of dependency and abuse. However, due to the large numbers of prescriptions being written for Oxycontin it is difficult to monitor the use and abuse of Oxycontin. Even though Oxycontin was originally intended to help cancer patients treat their chronic pain, more prescriptions are being written to treat moderate to severe non-cancer pain. The prescriptions for Oxycontin, particularly those to treat non-cancer pain, are growing rapidly, with nearly half of the prescriptions being made by primary care physicians.
According to the FDA, there is some concern that Oxycontin is being prescribed by physicians who are not properly trained in pain management. The FDA has cited Purdue Pharmaceuticals twice for using potentially false or misleading medical journal advertisements that violated the Federal Food, Drug and Cosmetic Act. As such, the FDA has taken action against Purdue Pharmaceutical. Purdue’s aggressive, and sometimes deceptive, advertising campaign promoting Oxycontin as a “general” pain reliever contributes to the cavalier attitude being taken. These attitudes have led to wide spread abuse of this potent pain medication. Other factors that contribute to the wide abuse of Oxycontin include:
* Availability of the drug: To those that need it and to those that do not.
* The warning label: Warns against the dangers of crushing Oxycontin because of the possibility of a rapid release of the potentially fatal narcotic in fact informed users of how to abuse the drug. All opioids carry a risk of dependency and abuse. For example heroin, a well-known narc otic, is a very potent opioid and comes with a very high risk of dependency and abuse.
* Inadequate research: The controlled release quality of Oxycontin led the FDA to believe it would have less potential for abuse than other pain medications of the same
* caliber and class. However, there was an oversight in the process of research, as the FDA did not consider that Oxycontin could be crushed or dissolved in water. Doing this disrupts the controlled release process and instead causes a rush or “high” in the user.
Congressional hearings were held in December 2001 and again in February 2002 to address the abuse of Oxycontin. Both the FDA and Purdue Pharmaceutical began to take steps to address the problems associated with the use and abuse of Oxycontin. In July 2001 the FDA strengthened the warnings and precautions section in the labeling, issuing a “black box” warning, the highest possible warning level. Together with Purdue Pharmaceuticals, the FDA also developed a risk management program to help detect the abuse of, and prevent abuse of, Oxycontin.
Purdue has also initiated programs to educate health care providers about the risks associated with the abuse of Oxycontin. They have issued a warning in the form of a “Dear Healthcare Professional” letter. The letter informs health care providers of the potential misuse of Oxycontin and reiterates the importance of discretion and necessity when prescribing the drug.
The letter was distributed widely to physicians, pharmacists, and other healthcare professionals in an attempt to thwart the writing of gratuitous prescriptions and to ensure that health care providers are communicating accurately and thoroughly the dangers associated with the use of Oxycontin to their patients.
The FDA continues to monitor the use and abuse of Oxycontin and is working together with other federal agencies and drug manufacturers to ensure that this drug continues to be available to those that need it, and that it is being used in appropriate ways. Discounting the abuse and addiction concerns, when properly prescribed and used as directed, Oxycontin is an effective pain medication for moderate to severe pain.