Mar 10, 2017
While we are deeply troubled by the abuse and misuse of our medication, this lawsuit paints a completely flawed and inaccurate portrayal of events that led to the crisis in Everett, Washington.
Read MoreMar 10, 2017
While we are deeply troubled by the abuse and misuse of our medication, this lawsuit paints a completely flawed and inaccurate portrayal of events that led to the crisis in Everett, Washington.
Read MoreJul 11, 2016
Purdue’s strong record of coordination with law enforcement has been acknowledged by the DEA and other key stakeholders familiar with our efforts. Since 2007, Purdue coordinated and provided information to Los Angeles-area law enforcement that helped lead to the convictions of criminal doctors and pharmacists referenced by the LA Times.
Read MoreMay 5, 2016
Purdue Pharma rejects the claims made by The Los Angeles Times (LAT) in “OxyContin’s 12-Hour Problem.” In an attempt to resurrect a long-discredited theory, the paper ignores the clinical and regulatory data that directly contradicts their story.
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May 10, 2016
Read Purdue Pharma’s letter to the Los Angeles Times editor concerning claims made by The Los Angeles Times in “OxyContin’s 12-Hour Problem.”
Read MoreMay 5, 2016
Nearly a decade ago, the FDA cited a lack of clinical evidence when it formally rejected the “fundamental premise” that patients receiving OxyContin at intervals more frequent than twice-daily are at increased risk of “side effects and serious adverse reactions.” In doing so, the agency reinforced the twice-daily labeling for OxyContin. The LAT omitted the findings of this report.
Read MoreWARNING: ADDICTION, ABUSE AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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 and conditions [see Warnings and Precautions (5.1)].
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.2)]. Under the requirements of REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
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 (5.3)].
Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.3)].
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 (5.4)].
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 (5.5), Drug Interactions (7), Clinical Pharmacology (12.3)].
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.6), Drug Interactions (7)].
Adult Indications and Usage
OxyContin is 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
CONTRAINDICATIONS
OxyContin is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint
Life-Threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
Adrenal Insufficiency
Severe Hypotension
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
Difficulty in Swallowing and Risk for Obstruction in Patients at Risk for a Small Gastrointestinal Lumen
Risks of Use in Patients with Gastrointestinal Conditions
Increased Risk of Seizures in Patients with Seizure Disorders
Withdrawal
Risks of Driving and Operating Machinery
Laboratory Monitoring
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535, option 2, or FDA at 1-800-FDA-1088.
Please read the Full Prescribing Information including Boxed Warning.