Extralong

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Oct 17, 2011
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SIS Patient Safety Alert 8/31/2016: Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death

This is an important alert from the Spine Intervention Society. We send out Patient Safety Alerts when we receive important information regarding products or services that can impact your patients' safety.

ISSUE: A review by the U.S. Food and Drug Administration (FDA) 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. See the FDA for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.

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 (see the FDA for a Data Summary). 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.

BACKGROUND: 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.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting
 

101N

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5+ Year Member
Apr 7, 2011
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Good on SIS.
 

willabeast

7+ Year Member
Mar 7, 2011
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anyone who read a basic pharmacology text in the 1970's knew all of this already. it is also on all the product inserts. i feel there is something wrong when someone is trying to educate docs in basic pharmacology but i cannot put my finger on why it bothers me. i would rather they said something like "SIS advises reading the package inserts before prescribing prescription medications." that sounds better to me. why pick on benzo/opioid interactions? all the interactions are important.
 

jettavr6

10+ Year Member
Feb 24, 2008
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anyone who read a basic pharmacology text in the 1970's knew all of this already. it is also on all the product inserts. i feel there is something wrong when someone is trying to educate docs in basic pharmacology but i cannot put my finger on why it bothers me. i would rather they said something like "SIS advises reading the package inserts before prescribing prescription medications." that sounds better to me. why pick on benzo/opioid interactions? all the interactions are important.
This is medical school pharmacology 101 and is probably even taught in North Korean medical schools. These are probably on the USMLE Step 2 exams.
 
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DOctorJay

15+ Year Member
May 8, 2004
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I tell my patients that you gas guys put people to sleep with these combos, but do it safely because you control the airway. That seems to resonate with some patients.
 
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Disciple

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Oct 18, 2004
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PCPs know this and cause drug-drug interactions all the time, with the extensive med regimens they have to manage.

This particular issue just has not really been brought to their attention, until recently.
 

willabeast

7+ Year Member
Mar 7, 2011
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PCPs know this and cause drug-drug interactions all the time, with the extensive med regimens they have to manage.

This particular issue just has not really been brought to their attention, until recently.
OK i think i understand now.
Amazon product
 

lobelsteve

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May 30, 2005
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I made a handout for patients and their primary care or Psychiatry Physicians. I made a PDF of the FDA Black Box warning statement and a copy of 101n paper in this thread. All patients who are on opiates and benzos will get this.
 
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