Common Errors in the media about OxyContin® (oxycodone HCl extended-release tablets) CII

Not all oxycodone formulations are OxyContin

The terms oxycodone and OxyContin should not be used interchangeably

Media reports frequently use the terms oxycodone and OxyContin interchangeably, creating the misperception that all oxycodone abuse involves OxyContin. News reports often mistakenly refer to OxyContin, even when other medications containing oxycodone are specifically named by authorities. Therefore, the distinction between oxycodone and OxyContin is important for the media to recognize.

Immediate-release (IR) formulations of oxycodone have a long history

Oxycodone is an opioid analgesic with a history of abuse. Introduced in the US in the late 1930s, oxycodone is still used in different drug formulations, many of which are generic. Generic oxycodone is manufactured by more than 20 drug makers.1 Oxycodone is frequently combined with aspirin or acetaminophen in IR formulations known commonly as Percodan®, Percocet®, and Tylox®. Immediate-release oxycodone is also available as a single agent (containing only oxycodone as the active ingredient) under the brand name Roxicodone®.

OxyContin is an extended-release (ER) formulation

While oxycodone is available in many different IR drug formulations, OxyContin is a Purdue Pharma brand for an ER formulation of oxycodone that was approved by FDA in December 1995. OxyContin has since been reformulated, and in 2010 FDA approved it with inactive ingredients intended to make the tablet more difficult to manipulate for misuse and abuse. In April of 2013, FDA approved abuse-deterrence labeling for OxyContin and said in their press release, “
labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via intranasal route (snorting).”2 It is important to understand that abuse of OxyContin by injection and intranasal routes, as well as by the oral route, is still possible. Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of OxyContin on the abuse liability of the drug. Accordingly, section 9.2 (titled Abuse) of the Full Prescribing Information may be updated in the future as appropriate.

ER opioid prescriptions are a small percentage of the total market

The opioid prescription market is divided between ER and IR analgesic products. ER formulations are a small percentage of the total number of opioid analgesic prescriptions written, accounting for approximately 11% of the total of all opioid analgesic prescriptions. Compare this to 89% of the total for IR prescriptions.3

IR prescriptions

OxyContin is only 2% of the total opioid prescription market3

Of the approximately 215 million prescriptions for opioids written in 2014, OxyContin accounts for approximately 9% of all oxycodone prescriptions, and only 2% of the overall opioid analgesic prescription market.3

Total prescriptions

Purdue is committed to abuse deterrence

For almost 30 years, Purdue Pharma has developed opioid medications prescribed to millions of patients. Purdue is acutely aware of the public health risks these medications create, especially when they are abused or misused. Pharmaceutical companies, including Purdue, are developing innovative technologies to create opioid medications in new forms that are more difficult to manipulate, and so are less gratifying to abusers. Purdue is also working with policymakers and health experts throughout the country to reduce the risks involving opioids. The technology used to develop opioids with abuse-deterrent characteristics is relatively new and is still evolving. In an effort to address the public health challenge of abuse, misuse, and diversion, Purdue is committed to playing an important role in the development of these opioid formulations.

The Full Prescribing Information of OxyContin has the following Boxed Warning:

WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse

OxyContin® exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OxyContin and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of OxyContin. Monitor for respiratory depression, especially during initiation of OxyContin or following a dose increase. Instruct patients to swallow OxyContin tablets whole; crushing, chewing, or dissolving OxyContin tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of OxyContin, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of OxyContin during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Cytochrome P450 3A4 Interaction

The concomitant use of OxyContin with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OxyContin and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.14) and Clinical Pharmacology (12.3)].

Indications and Usage

OxyContin is an opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve OxyContin for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain
  • OxyContin is not indicated as an as-needed (prn) analgesic
Contraindications

OxyContin is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus and gastrointestinal obstruction
  • Hypersensitivity (e.g., anaphylaxis) to oxycodone
Additional Important Safety Information
  • OxyContin contains oxycodone, a Schedule II controlled substance. OxyContin exposes users to the risks of opioid addiction, abuse, and misuse. As modified-release products such as OxyContin deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse or misuse prior to prescribing OxyContin and monitor all patients during therapy for the development of these behaviors or conditions.
  • Instruct patients to swallow the OxyContin tablets intact. Crushing, chewing, snorting, or injecting the dissolved product could result in overdose and death.
  • Serious, life-threatening, or fatal respiratory depression has been reported with modified-release opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of OxyContin are essential. Overestimating the OxyContin dose when converting patients from another opioid product can result in fatal overdose with the first dose.
  • Accidental ingestion of even one dose of OxyContin, especially by children, can result in respiratory depression and death due to an overdose of oxycodone.
  • Prolonged use of OxyContin during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts.
  • Hypotension, profound sedation, coma, respiratory depression, or death may result if OxyContin is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with 1/3 to 1/2 the usual dose of OxyContin, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.
  • Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic pulmonary disease if possible.
  • OxyContin may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock.
  • Monitor patients taking OxyContin who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of OxyContin in patients with impaired consciousness or coma.
  • OxyContin is contraindicated in patients with GI obstruction, including paralytic ileus. Use caution when prescribing OxyContin for patients who have difficulty swallowing, or have underlying GI disorders that may predispose them to obstruction. Consider use of an alternative analgesic in these patients.
  • OxyContin may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • OxyContin may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control.
  • Avoid the use of mixed agonist/antagonist or partial agonist analgesics in patients who have received or are receiving OxyContin, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin.
  • OxyContin may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
  • Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved.

Please read the full Prescribing Information for OxyContin Tablets, available at http://app.purduepharma.com/oxycontinpi.

To learn more about Purdue’s initiative against abuse, misuse, and diversion of opioid formulations, visit RxSafetyMatters.org and explore the various programs partnered with Purdue that are committed to curbing this public health challenge.

References

1. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm?firstRec=1. Accessed January 27, 2015.

2. FDA News Release. April 16, 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm. Accessed January 27, 2015.

3. IMS Health—NPA, based on TRx yearly data, December 2014.

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