FDA issues strong warnings for opioid analgesics

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Opioids like oxycodone, hydrocodone, morphine etc. are powerful pain-killers used primarily to manage chronic pain e.g. Opioid cough products are potent cough suppressants, whereas benzodiazepines are used for treating anxiety disorders, insomnia and seizures. Both act as CNS depressants and their concomitant use risks a person to extreme sleepiness, respiratory depression, coma, or even death. FDA’s step of issuing a strong warning against concomitant use comes as an effort in reduction of iatrogenic deaths or emergency admissions due to opioid and benzodiazepines concomitant use. (1, 2)

Problem Situation

A recent data review by FDA observed that physicians have been increasingly prescribing a combination of opioids and benzodiazepines, which has been associated with adverse outcomes. Another data review showed a 41% increase in the combined use of benzodiazepine and opioid analgesics, from 2002 to 2014, which estimates that over 2.5 million patients are receiving opioid analgesics and benzodiazepines simultaneously. Another review revealed that between 2004 and 2011, the rate of emergency unit visits involving the non-medical use of both these class of drugs has significantly increased. (3, 4)

Drug interaction

 Several studies have elucidated the mechanism underlying opioids and benzodiazepines co-abuse by examining how these two classes of drugs interact with one another. Studies revealed that opioids and benzodiazepines exert significantly modulatory effects on each other. One of the possible mechanisms that explain this is that benzodiazepines alter the pharmacokinetics of opioids. When benzodiazepines are administered approximately an hour prior to opioids, an increase in opioid concentration occurs in the brain and liver along with reduction in urinary and hepatic opioid metabolites. (5)

Complications of benzodiazepines and opioids co-use

Benzodiazepines and opioid co-use overdose can produce:

  • Extreme drowsiness
  • Respiratory depression
  • Coma
  • Death

FDA’s Warning (6, 4)

 For Doctors

FDA has asked healthcare professionals the following:

  • To limit prescribing opioid analgesics along with benzodiazepines as well as other CNS depressants, to patients for whom alternative treatments options are available
  • If alternative treatment options are unavailable, then to limit the dosage as well as duration of each drug
  • To warn patients regarding the risks of slowed respiration and/or excessive sleepiness as well as associated signs and symptoms

 For Pharmacies

  • To provide boxed warning
  • To provide medication guides, to patients with information regarding the serious risks associated with the use of these medications.
Copyright © 2016 BorderlessAccess
Credit: Dr. Rachita on behalf of Borderless Access

Reference Sources:

  1. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3454351/
  2. http://www.ncbi.nlm.nih.gov/pubmed/15762817
  3. https://www.drugabuse.gov/news-events/nida-notes/2012/04/well-known-mechanism-underlies-benzodiazepines-addictive-properties
  4. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm
  5. https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/americas-addiction-to-opioids-heroin-prescription-drug-abuse
  6. http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm

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