FDA Changes Opioid Labeling to Give Providers Better Information on Tapering Noting that the agency remains focused on striking the right balance between policies that reduce the rates of opioid addiction while still allowing patients and health care providers access to appropriate pain treatments, Food and Drug Administration (FDA) has announced required changes to the prescribing information for all opioid analgesic medications used in the outpatient setting. The changes, announced in a Drug Safety Communication, provide expanded information to health care providers on how to safely decrease the dose in patients who are physically dependent on opioids. FDA intends for this information to be used when health care providers and patients have decided together that a decrease in dose or discontinuation of opioids is appropriate. “Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse,” the agency said in the communication. “Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.”In addition to these changes, an FDA press release also announced that additional policies related to the opioid crisis are forthcoming. These include a requirement for immediate-release formulations of opioids to be made available in fixed-quantity packaging that contain doses more typical of what patients may need for common acute pain conditions and procedures. The full press release is available in the News and Events section of the FDA website
https://nabp.pharmacy/wp-content/uploads/2016/06/Kentucky-Newsletter-September-2019.pdf
Filed under: General Problems
Any forced apering causes uncontrolled pain! My daughter is in the hospital with necrotizing faciitus, 6 surgeries and 5 transfusions in 2 weeks. Her latest surgery was yesterday yet already they are denying a large portion of needed medication for pain ” in preparation for DISCHARGE”! The last time she had this (not nearly as encompassing as this time) she was hospitalized for 82 days! Appropriate medical care, not just pain control, is nonexistent!!
Yes because it is really true that DOCTORS of Medicine are incompetent and gullible. I say fire them all in that case and let junior employees at the FED decide while their bosses are on vacation.