Statement of Purdue Pharma L.P. Regarding OxyContin® (oxycodone HCl controlled-release) Tablets Risk Evaluation and Mitigation Strategy
July 29, 2010 – Working with the FDA, Purdue has developed a Risk Evaluation and Mitigation Strategy (REMS) for OxyContin® Tablets. The goals of the OxyContin REMS Program are twofold:
- To inform patients and healthcare professionals about the potential for abuse, misuse, overdose, and addiction of OxyContin; and
- To inform patients and healthcare professionals about the safe use of OxyContin.
The OxyContin REMS includes:
- A Medication Guide to inform patients;
- A Dear Healthcare Professional Letter to inform healthcare professionals;
- A Training Guide to educate prescribers;
- An Education Confirmation Form for prescribers to confirm their training completion; and
- Timetable for submitting assessments of various elements of the REMS.
The REMS program encourages prescribers to sign and return the Education Confirmation Form, or it may be completed online at www.oxycontinrems.com, however, the prescriber’s ability to prescribe OxyContin is not dependent upon completion of the Education Confirmation Form.
REMS-related materials for OxyContin have been mailed to selected prescribers of OxyContin. In addition, content is available to all healthcare professionals at www.oxycontinrems.com or by calling Purdue Pharma’s Medical Services Department (1-888-726-7535), and through distribution by the Company’s field sales representatives. For patients and caregivers, the OxyContin REMS web site provides information in the form of the Medication Guide for OxyContin. Patients and caregivers should also request a copy of the Medication Guide from their pharmacist with every prescription of OxyContin they receive.
This is a product-specific REMS for OxyContin. FDA is requiring the ongoing development of a class REMS for several long-acting opioid analgesic products that, once approved by the FDA, will replace the OxyContin REMS.
Indications and Usage
OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Usage
OxyContin is not intended for use on an as-needed basis.
As used here, “moderate” and “moderate to severe” pain do not include commonplace and ordinary aches and pains, pulled muscles, cramps, sprains, or similar discomfort.
OxyContin is not indicated for the management of pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time.
OxyContin is indicated for postoperative use following the immediate post-operative period only if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)
OxyContin is not indicated for pre-emptive analgesia (preoperative administration for the management of postoperative pain).
OxyContin is not indicated for rectal administration.
The professional product labeling for OxyContin® Tablets contains the following boxed warning:
WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSEOxyContin contains oxycodone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. (9)
OxyContin can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9.2)
OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1)
OxyContin is not intended for use on an as-needed basis. (1)
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant or sedating effects of opioids. (2.7)
Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. (2.2)
OxyContin must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. (2.1)
The concomitant use of OxyContin with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression. Patients receiving OxyContin and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (7.2).
OxyContin® is contraindicated in patients who have significant respiratory depression, patients who have or are suspected of having paralytic ileus, patients who have acute or severe bronchial asthma, and patients who have known hypersensitivity to any of its components or the active ingredient, oxycodone.
Additional Safety Information
Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs such as benzodiazepines, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Use low initial doses of OxyContin® in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications.
Serious adverse reactions which may be associated with OxyContin® Tablet therapy in clinical use are respiratory depression, apnea, respiratory arrest, and circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.
Full prescribing information for OxyContin is available at
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found atwww.purduepharma.com.