FDA warnings for combined use of opioid analgesics, prescription opioid cough products, and benzodiazepine labeling

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FDA warnings for combined use of opioid analgesics, prescription opioid cough products, and benzodiazepine labeling

The U.S. FDA reported that it will entail class-wide changes to drug labeling including patient information, to aid in informing health care providers and patients of the serious risks associated with combined use of certain opioids and a class of central nervous system (CNS) depressant drugs called benzodiazepines. This was based after an extensive review of the latest scientific evidence.

Among alterations, FDA is requiring boxed warnings, FDA’s strongest warning and patient-focused medication guides. These will be made for nearly 400 products including prescription opioid analgesics, opioid-containing cough products, and benzodiazepines with information about the associated serious risks. The risks are sleepiness, respiratory depression, coma and death. FDA is taking a number of steps as part of agency’s Opioids Action Plan, which highlights the policies which seeks reversing the prescription opioid abuse epidemic.

FDA Commissioner, Robert Califf said “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together." He added “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on patient-by-patient basis, whether benefits of using opioids and benzodiazepines or CNS depressants more generally together outweigh these serious risks.”

FDA also reported a Drug Safety Communication, given the significance of reaching health care professionals and public with information about the risks of using these products together. Through Drug Safety Communication and by requiring patient medication guides, the agency also furnished information for anyone who is taking, or who knows someone taking, either of these types of medications and encourages them to better understand the risks of taking them jointly. Also, information regarding when it is medically necessary, for health care providers to be cautious to prescribe them as directed, without increasing the dose/frequency for either drug is being considered.

Opioid analgesics are strong pain-reducing medications encompassing prescription oxycodone, hydrocodone, and morphine, among other drugs, under both brand and generic names. Opioid analgesic misuse and abuse have increased in the USA and represent major public health concerns due to the risk of coma and fatal respiratory depression. For managing neurological or psychological conditions, benzodiazepines are typically prescribed. Each class of drug has distinctive pharmacology, safety risks, and labeling information related to its use, but both are CNS depressants. Hence, FDA is requiring opioid analgesics, prescription opioid cough products, and benzodiazepines to have slightly different labeling. Also, FDA is continuing to scrutinize available evidence regarding the use of benzodiazepines and opioids used as part of medication-assisted therapy treatment (MAT) due o the unique medical needs and benefit/risk considerations for patients undergoing MAT.

According to FDA’s data review, physicians have been continuously prescribing them together, and this has led to adverse outcomes. From 2004 to 2011, rate of emergency department visits involving non-medical use of both drug classes has increased, with overdose deaths involving both drug classes nearly tripling during that period. Between 2002 and 2014, patients with opioid analgesic and benzodiazepine prescription increased by 41%. FDA received citizen petition from local and state public health officials and stakeholders asking to make certain changes to existing labeling for benzodiazepines and opioid analgesics. The FDA had already begun a review of the scientific information on concomitant use of these two classes when the agency received the petition, and was motivated that these public health officials shared the agency’s concerns.

The foremost priority for the FDA is working with the health care community and federal and state partners to assist in reducing opioid misuse and abuse and improve appropriate opioid prescribing, while ensuring that patients in pain continue to have appropriate access to opioid analgesics. Also, a part of HHS’ targeted approach strived on prevention, treatment, and intervention. The agency is devoted to continuing to monitor these products and take further actions as required.

The FDA agency under the U.S. Department of Health and Human Services, safeguards the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The responsibility for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products is also the duty of the FDA.

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