The United States: Opioid pain or cough medicines combined with Benzodiazepines: Drug Safety Communication - FDA requiring Boxed Warning about serious risks and death (English Only)

The United States: Opioid pain or cough medicines combined with Benzodiazepines: Drug Safety Communication - FDA requiring Boxed Warning about serious risks and death (English Only)
 
The U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, their strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. A listing of all US-approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants can be found at the FDA website. 

FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol. Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling. 

FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available. 

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. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures. 

Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol. 

Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/MedWatch/../ucm518710.htm 

In Hong Kong, there are 456 registered pharmaceutical products which contain the opioid pain or cough medicines listed in the FDA website, including: alfentanil (1 product), buprenorphine (8), codeine (319), dihydrocodeine (10), fentanyl (11), methadone (5), morphine (24), oxycodone (13), remifentanil (6), sufentanil (2), tapentadol (8) and tramadol (49); while butorphanol, hydrocodone, hydromorphone, meperidine, oxymorphone or pentazocine are not registered. There are 89 registered pharmaceutical products which contain benzodiazepines listed in the FDA website, including: alprazolam (17), chlordiazepoxide (10), clobazam (1), clonazepam (10), clorazepate (1), diazepam (32), flurazepam (2), lorazepam (15) and triazolam (1); while estazolam, oxazepam, quazepam and temazepam are not registered. So far, the Department of Health (DH) has not received any adverse drug reaction report in connection with the concomitant use of opioid medicines and benzodiazepines. 

CNS-related serious adverse effects, including slowed or difficult breathing and/ or sedation, are well-established adverse effects of opioid medicines and benzodiazepines which are documented in reputable drug references such as Martindale: the Complete Drug Reference. In view of the above strengthened warning by the FDA, letters to reinforce local healthcare professionals of the risks will be issued. DH will remain vigilant on any safety update on opioid medicines and benzodiazepines from other overseas drug regulatory authorities. 


Ends/ Thursday, September 01, 2016 
Issued at HKT 15:00 
 

 

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