Drugs

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

 

Resources for You

Page Last Updated: 08/31/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English