FDA labeling changes target Rx misuse

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Stronger warnings required for certain opioid, CNS drugs

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SILVER SPRING, Md. — Citing dangers from combined use, the Food and Drug Administration is requiring classwide changes to labeling for opioid analgesics, prescription opioid cough products and benzodiazepines, a group of central nervous system depressant drugs.

The FDA said Wednesday that the changes mandate boxed warnings — the agency’s strongest warning — and patient medication guides for nearly 400 products overall. The information is intended to better inform health care providers and patients about the serious risks of using these medications at the same time. Risks include extreme sleepiness, respiratory depression, coma and death.

The agency, too, has issued a Drug Safety Communication about the risks of combined use of these medicines.

An extensive review of scientific data by the FDA revealed that doctors have been increasingly prescribing opioid painkillers and benzodiazepines together, which has correlated with adverse outcomes.

The agency said it found that from 2004 to 2011, the rate of emergency room visits involving nonmedical use of both drug classes surged, with overdose deaths — from taking prescribed or greater than prescribed doses — nearly tripling during that period.

Also, the number of patients prescribed both an opioid analgesic and benzodiazepine climbed 41% between 2002 and 2014, an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.

Robert Califf_FDA_headshot

Robert Califf

“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,” FDA Commissioner Robert Califf said in a statement. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines — or CNS depressants more generally — together outweigh these serious risks.”

Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among other drugs, under brand and generic names. Other opioid drugs are also approved to treat cough. The FDA noted that opioid analgesic misuse and abuse have soared in the United States over the past two decades and are major public health concerns because of the risk of coma and fatal respiratory depression from overdosing.

Benzodiazepines are prescribed for neurological and/or psychological conditions, including anxiety, insomnia and seizure disorders. Both classes of drugs depress the central nervous system, yet each has unique pharmacology, safety risks and labeling information related to its use, according to the FDA. As a result, the agency said it’s requiring opioid analgesics, prescription opioid cough products and benzodiazepines to have slightly different labeling. The FDA also is assessing evidence on the use of benzodiazepines and opioids as part of medication-assisted therapy treatment (MAT) for opioid addiction and dependence.

The FDA said the labeling actions come as part of its Opioids Action Plan, which focuses on policies to reverse the prescription opioid abuse epidemic without impeding chronic pain patients’ access to pain medications.

This past February, the FDA received a citizen petition from local and state public health officials and other stakeholders asking the agency to make certain changes to the current labeling for benzodiazepines and opioid analgesics. The FDA said it had already initiated a review of data on combined use of these two drug classes when it received the petition.

The agency added that its labeling actions are in line with clinical guidelines from the Centers for Disease Control and Prevention (CDC) and existing labeling warnings regarding combined use caution prescribers about co-prescribing opioids and benzodiazepines to avoid potential serious health outcomes.



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