New Safety Measures Announced for Opioid Analgesics, Prescription Opioid Cough Products, and Benzodiazepines
[8-31-16] After an extensive review of the latest scientific evidence, the U.S. Food and Drug Administration announced today that it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.
Among the changes, the FDA is requiring boxed warnings and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines – nearly 400 products in total – with information about the serious risks associated with using these medications at the same time. Risks include extreme sleepiness, respiratory depression, coma and death. Today’s actions are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.
Important Information for Patients
FDA is warning patients and their caregivers about the serious risks of taking opioids along with benzodiazepines or other central nervous system (CNS) depressant medicines, including alcohol. Serious risks include unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, coma, and death. These risks result because both opioids and benzodiazepines impact the CNS, which controls most of the functions of the brain and body.
- Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They are also approved in combination with other medicines to reduce coughing. Common side effects include drowsiness, dizziness, nausea, vomiting, constipation, and slowed or difficult breathing. Opioids also carry serious risks, including misuse and abuse, addiction, overdose, and death. Examples of opioids include oxycodone, hydrocodone, codeine, and morphine.
- Benzodiazepines are drugs prescribed for to treat conditions like anxiety, insomnia, and seizures. Examples of these drugs include: alprazolam, clonazepam, and lorazepam. Common side effects include drowsiness, dizziness, weakness, and physical dependence.
If you are taking both opioids and benzodiazepines together, consult your health care provider to see if continued combined use is needed. For more information, please see the FDA Drug Safety Communication.
August 31, 2016
- FDA News Release: FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
Action to better inform prescribers and protect patients as part of Agency’s Opioids Action Plan
- FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
- Due to the scope of changes being made to the labels of the opioid analgesics, prescription opioid cough medications, and benzodiazepines, FDA is posting example letters that best capture the breadth of the announced safety labeling changes being required:
Example: opioid analgesic Safety Labeling Change notification letter) (PDF - 72KB)
Example: opioid cough medication Safety Labeling Change notification letter (PDF - 180KB)
Example: benzodiazepine Safety Labeling Change notification letter (PDF - 185KB)
- FDA Response to Citizen Petition: Leana Wen, M.D. M.Sc. and Nicole Alexander-Scott, M.D., M.P.H., Docket ID FDA-2016-P-0689
The petition requests that FDA add a black box warning on all opioid analgesic and benzodiazepine class medications and require Medication Guides for both classes of medications that specifically warn patients of the potential dangers of combined use of opioids and benzodiazepines.