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FDA warns of opioid painkillers side effects risk

The Food and Drug Administration has introduced a new treatment strategy to help limit the number of overdoses and other side effects caused by long-acting prescription painkillers known as opioids. Also known as a Risk Evaluation and Mitigation Strategy (REMS), the FDA’s new program is designed to inform patients about how to use opioid painkillers safely while ensuring that patients who need these drugs continue to receive access.

The REMS was instituted in response to the serious public health crisis of addiction, overdose and death related to long acting opioids. The program was developed by FDA and will include more than 20 companies and more than 30 brands of painkillers, including Duragesic, OxyContin, MS Contin, Opana ER, and Butrans.

This new REMS will require the makers of long acting opioid analgesics to provide training for health care professionals who prescribe these painkillers. This program will educate doctors on proper prescribing practices and will also distribute educational materials to prescribers and patients on the safe use of these powerful pain medications.

Essentially, the FDA is attempting to educate doctors to avoid errors and risky prescribing decisions related to long-acting opioids. The expected results of the prescriber education are that the prescribers will:

  1. Understand how to assess patients for treatment with ER/LA opioid analgesics.
  2. Be familiar with how to initiate therapy, modify dose, and discontinue use of ER/LA opioid analgesics.
  3. Be knowledgeable about how to manage ongoing therapy with ER/LA opioid analgesics.
  4. Know how to counsel patients and caregivers about the safe use of ER/LA opioid analgesics, including proper storage and disposal.
  5. Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics.