Improving information supplied with gabapentinoids (pregabalin/gabapentin), benzodiazepines and z-drugs

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a drug safety update following a review of the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs.

The Public Assessment Report found that it was necessary to strengthen these warnings in the product information and on packaging to better inform healthcare professionals and patients of these known risks.

The summary of product characteristics, patient information leaflets and outer packaging of these medicines will have strengthened warnings to better communicate the risks of addiction, dependency, withdrawal and tolerance to healthcare professionals and patients. Updates are in progress and will be rolled out over the coming months.

Prior to starting treatment with these medicines, a discussion should be held with patients to put in place a strategy for reducing or ending treatment. By doing this the risk of addiction, dependence, and drug withdrawal syndrome is reduced. The drug safety alert contains advice for healthcare professionals and advice to provide to patients. 

The MHRA has also published additional patient resources which highlight key messages concerning these risks and should be made available to patients when these medications are prescribed.

Further information, advice, actions and resources for healthcare professionals can be found in the Drug Safety Update.