Drug Safety Warnings and Updates: January-March 2018

Shannon Thor, PharmD, MS


May 23, 2018

Editorial Collaboration

Medscape &

In This Article

Methadone hydrochloride (Methadone Hydrochloride; Methadose)

For more on this Drug Safety Labeling Change, click here and here for methadone hydrochloride, and here for Methadose.

For full prescribing information, click here.

Updated Boxed Warning

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death.

Reserve concomitant prescribing of benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting daily methadone dosing.