On Monday, the FDA issued a drug safety communication for new label warnings on opioid drugs, alerting that suddenly quitting the addictive painkillers can lead to devastating withdrawal conditions including the use of illicit drugs, recurring pain, and other complications.
The federal regulators received various reports of serious side-effects affecting patients who abruptly quit the medications. The agency asked changes to be implemented to the prescribing information for any opioids intended for outpatient use. The information must include the risks of sudden discontinuation of the medication and a guide for doctors on how to safely reduce and gradually stop the opioid treatment for the patients. Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, told, "the FDA has received reports of serious harm, withdrawal symptoms, uncontrolled pain, and suicide among patients who were physically dependent on opioids, but not considered addicted." The FDA instructed health care professionals to develop a patient-specific plan to tone down the dosage of opioids, and eventually cut-off the treatment, by considering the duration and type of pain involved. Soon, the FDA will chart out new policies to address the national opioid crisis, including prescribing guidelines and fixed-quantity packaging for immediate-release formulations.
