Safety Alerts & Recalls

What does this mean?

The benefits of extended-release (ER) and long-acting (LA) opioid pain medicines continue to outweigh the risks when used appropriately. This alert is to inform you about the new risk management plan (REMS) for extended-release (ER) and long-acting (LA) opioid pain medicines. The highlight of the new REMS for the ER/LA opioid medicines is education for prescribers and patients about the proper and safe use of these medicines. The program also aims to ensure continued access to needed medications for patients in pain.

If you are currently taking ER/LA opioid pain medicines, you should continue to take your medications as directed. You should read the Medication Guide provided with your prescription pain medicine. The Medication Guide will include general safety information, including:

- Instructions not to change your dose without consulting your doctor

- The signs that indicate you may have taken too much medication

- Instructions to seek emergency help in an overdose situation

Your doctor or other healthcare provider may also provide you with the patient counseling document, which will include:

- A list of do’s and don't

- Information on when to call your health care provider or emergency service

- Patient-specific information from your health care provider

If you have any concerns about the medications you are taking or think you are experiencing side effects, you should consult with your healthcare provider.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Approves Safety Program to Reduce Risk of Opioid Pain Relievers

Opioids are safe and effective when used properly to treat chronic pain, but when used improperly or for recreational purposes, they can cause serious harm, including overdose and death.

To reduce these risks as much as possible, the Food and Drug Administration (FDA) has announced a risk management plan for a class of opioid medications, known as extended-release (ER) and long-acting (LA) opioid analgesics. This plan, known as a Risk Evaluation and Mitigation Strategy (REMS), is designed to ensure that healthcare professionals are trained on how to properly prescribe these medicines and how to instruct their patients about using them safely. The REMS is also part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic.

Examples of ER/LA opioids include Avinza, Butrans, Dolophine, Duragesic, Embeda, Exalgo, Kadian, MS Contin, Nucynta ER, Opana ER, and OxyContin. For a detailed list of ER/LA opioids, including the generic name and manufacturer, please visit: more information here

The REMS introduces the following safety measures designed to reduce risks and improve the safe use of ER/LA opioids: 1) Training for healthcare professionals - The companies that make ER/LA opioids will be required to make educational training available for healthcare professionals on the safe prescribing of ER/LA opioid medications. Healthcare professionals who participate in the REMS program will have be more knowledge and can have honest and in-depth conversations with their patients about the risks and appropriate use of opioids.

2) Updated Medication Guide and counseling document for patients - These materials contain consumer-friendly information on the safe use, storage and disposal of ER/LA opioid analgesics. Also included are instructions to consult one’s doctor or other prescribing healthcare provider before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.

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Source: FDA
Publication Date: 2012-07-10
Last Updated: 2012-07-10

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