People who suffer chronic pain face a good news/bad news situation in choosing a treatment. There are powerful medicines called opioids that can help manage pain when prescribed for the right condition and when used properly. But when prescribed by physicians to patients who should not receive them, or 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 approved a risk management plan for a class of opioid medications, known as extended-release (ER) and long-acting (LA) opioid analgesics, used to treat moderate to severe chronic pain. This plan is designed to ensure that health care professionals are trained on how to properly prescribe these medicines and how to instruct their patients about using them safely.
“There are a limited number of options available for the treatment of pain. Opioids are one option, but they carry a significant risk of misuse, abuse, overdose and death,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products. “We’re trying to help physicians manage the risks and improve the safety of using these medicines.”
Opioids—so named because they are synthetic versions of opium—are narcotics that work by changing the way the brain perceives pain. They are available— in forms that include pills, liquids and skin patches—to treat moderate to severe chronic pain. Hertz explains that the ER/LA opioids are more of a safety concern than immediate-release formulas because they are stronger and either stay in the body longer or are released into the body over longer periods of time. The drugs that will be required to have a REMS include:
- Butrans (transdermal buprenorphine)
- Dolophine (methadone)
- Duragesic (transdermal fentanyl)
- Exalgo (hydromorphone)
- MS Contin
- Opana ER (oxymorphone).
- Oramorph (all morphines)
- OxyContin (oxycodone)
“When too much is taken, the risk of overdose is serious and it can cause death,” says Hertz. “We’ve seen that happen to people who overdose accidentally when they are taking an opioid for pain and to others who are taking it to get high.”
Hertz says that’s why it’s important that patients securely store their medications, both to prevent the accidental exposure of family members and to keep them away from others looking to get high.
And patients should not be sharing their pain relievers, Hertz says. “Just because it’s safe for the patient, doesn’t mean it’s safe for someone else,” she says, noting that there have been cases of people overdosing and dying after taking an opioid medication prescribed for a friend or family member.