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FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

This provides updated information to the FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning issued on August 31, 2016.

Safety Announcement

[9-20-2017] Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks. We are requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.

Buprenorphine and methadone help people reduce or stop their abuse of opioids, including prescription pain medications and heroin. Methadone and buprenorphine have been shown to be effective in reducing the negative health effects and deaths associated with opioid addiction and dependency.1 These medications are often used in combination with counseling and behavioral therapies, and patients can be treated with them indefinitely. Buprenorphine and methadone work by acting on the same parts of the brain as the opioid that the patient is addicted to. The patient taking the medication as directed generally does not feel high, and withdrawal does not occur. Buprenorphine and methadone also help reduce cravings2 (see Table 1. List of Buprenorphine and Methadone MAT Drugs).

Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a health care professional’s direction or illicitly. Although there are serious risks with combining these medicines, excluding patients from MAT or discharging patients from treatment because of use of benzodiazepines or CNS depressants is not likely to stop them from using these drugs together. Instead, the combined use may continue outside the treatment setting, which could result in more severe outcomes.

Health care professionals should take several actions and precautions and develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. These include:

Patients taking MAT drugs should continue to take these medicines as prescribed. Do not stop taking other prescribed medicines without first talking to your health care professional. Before starting any new medicines, tell your health care professional that you are taking MAT. Do not take non-prescribed benzodiazepines or other sedatives (See Table 2. List of Benzodiazepines and Other CNS Depressants) or use alcohol when taking MAT because the combined use increases the possibility of harm, including overdose and death.

In August 2016, we issued a Drug Safety Communication warning about the combined use of opioid-containing pain or cough medicines with benzodiazepines or other CNS depressants. We said at that time that we would continue to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with MAT drugs.

Our subsequent review of a published study3 and other drug use data showed that buprenorphine and benzodiazepines frequently have been prescribed for the same patient, often by the same prescriber, and these drugs are usually dispensed by the same pharmacy. An epidemiological study from Sweden found that receiving MAT with benzodiazepines or other CNS depressants such as drugs to treat insomnia appears to increase the risk of death.4 Based on this information, for the methadone products, information about the interaction with benzodiazepines and other CNS depressants will be added to an existing Boxed Warning about the risks of slowed or difficult breathing and death. Expanded guidance will be added to the Warnings and Precautions section on how to manage patients in methadone treatment in Opioid Treatment Programs (OTPs) who are also taking CNS depressants. For the buprenorphine products, an existing statement in the Warnings and Precautions section will be expanded and revised to provide more detailed guidance on managing patients in buprenorphine treatment who are also taking CNS depressants.

We urge patients and health care professionals to report side effects involving buprenorphine, methadone, or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Table 1. List of Buprenorphine and Methadone MAT Drugs

Generic Name Brand Name(s)
buprenorphine Subutex, Probuphine
buprenorphine/naloxone Bunavail, Suboxone, Zubsolv
methadone Diskets, Dolophine, Methadose

Table 2. List of Benzodiazepines and Other CNS Depressants*

Generic Name Brand Name(s)
Benzodiazepines
alprazolam Xanax, Xanax XR
chlordiazepoxide Librium, Librax
clobazam Onfi
clonazepam Klonopin
clorazepate Gen-Xene, Tranxene
diazepam Diastat, Diastat Acudial, Valium
estazolam No brand name currently marketed
flurazepam No brand name currently marketed
lorazepam Ativan
oxazepam No brand name currently marketed
quazepam Doral
temazepam Restoril
triazolam Halcion
Other Sleep (Non-Benzodiazepine Hypnotic) Drugs and Tranquilizers
butabarbital sodium Butisol
eszopiclone Lunesta
pentobarbital Nembutal
ramelteon Rozerem
secobarbital sodium Seconal sodium
suvorexant Belsomra
zaleplon Sonata
zolpidem Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist
Muscle Relaxants
baclofen Gablofen, Lioresal
carisoprodol Soma, Soma Compound, Soma Compound w/ codeine
chlorzoxazone No brand name currently marketed
cyclobenzaprine Amrix
dantrolene Dantrium, Revonto, Ryanodex
metaxalone Skelaxin
methocarbamol Robaxin, Robaxin-750
orphenadrine No brand name currently marketed
tizanidine Zanaflex
Antipsychotics
aripiprazole Abilify, Abilify Maintena, Aristada
asenapine Saphris
cariprazine Vraylar
chlorpromazine No brand name currently marketed
clozapine Clozaril, Fazaclo ODT, Versacloz
fluphenazine No brand name currently marketed
haloperidol Haldol
iloperidone Fanapt
loxapine Adasuve
lurasidone Latuda
molindone No brand name currently marketed
olanzapine Symbyax, Zyprexa, Zyprexa Relprevv, Zyprexa Zydis
paliperidone Invega, Invega Sustenna, Invega Trinza
perphenazine No brand name currently marketed
pimavanserin Nuplazid
quetiapine Seroquel, Seroquel XR
risperidone Risperdal, Risperdal Consta
thioridazine No brand name currently marketed
thiothixene Navane
trifluoperazine No brand name currently marketed
ziprasidone Geodon

*This is not a comprehensive list.

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