The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were 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.

Advice for Healthcare Professionals:

  • Gabapentinoids (pregabalin and gabapentin), benzodiazepines and z-drugs are three classes of medicines used to treat a variety of conditions such as neuropathic pain, anxiety and insomnia. Specialist use of these medications for conditions such as epilepsy, or sedation during medical procedures are not included in this review
  • All three classes of medications are known to pose risks of addiction, dependency, withdrawal and tolerance
  • 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. NICE guideline, NG215, has resources that include visual summaries which are available to support these discussions. The Agency has also developed additional patient resources for benzodiazepines, gabapentinoids and z-drugs which highlight key messages concerning these risks and should be made available to patients when these medications are prescribed
  • Addiction and dependence are related but have distinct presentations. Healthcare professionals are reminded of the importance of using non-judgmental language when discussing these terms
  • Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. This could be a sign that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient
  • Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to reduce symptoms of withdrawal. Tapering from a high dose may take weeks or months. Patients should be informed of this when the medication is first prescribed and should be encouraged to speak to their healthcare professional or prescriber before stopping their medicine. See NICE guideline NG 215 for identifying and managing withdrawal symptoms
  • Provide regular support especially to individuals at increased risk of drug withdrawal syndrome, such as those with current or past history of substance use disorder (including alcohol misuse) or mental health disorder
  • Addiction, dependence, withdrawal or tolerance in response to these medications can be reported via the Yellow Card scheme

Advice for Healthcare Professionals to Provide to Patients:

  • As these medicines carry risks of addiction, dependence and withdrawal reactions, before starting treatment with these medicines, your healthcare professional should explain how long you might need to take them for, and how to stop safely. This helps reduce the risk of addiction, dependence, and drug withdrawal syndrome
  • Anyone can become physically dependent on these medicines, meaning that their body gets used to it, and this can cause them to have withdrawal symptoms if the medicine is suddenly stopped, or the dose is reduced
  • Drug addiction can feel like a strong desire to take the medicine, and difficulties in controlling medicine use (for example feeling like you want to take more or use the medicine when you shouldn’t)
  • Addiction and dependence are related but they are not the same, being physically dependent on a medicine does not necessarily mean you are addicted to it
  • Drug tolerance can mean no longer feeling like the medicine is working well, or feeling that a higher dose is required to achieve the same symptom relief as before
  • If you want to stop taking your medicine there are additional resources to help you. Never stop taking your medication without asking a healthcare professional first
  • If you are taking this medicine for epilepsy, you should keep taking it for as long as your doctor says it’s needed
  • If you find that your treatment is not working as well, you should speak to your healthcare professional about possible alternative treatment options, and you should never take more of your medicine than you have been prescribed
  • When it is time to stop your medication, your healthcare professional will tell you how to gradually reduce the amount of medicine you are taking over time (known as dose tapering). This is very important to reduce the risk of drug withdrawal syndrome. Dose tapering can sometimes take weeks or months. Mild symptoms may still occur, but you should contact your healthcare professional if the withdrawal symptoms become intolerable

For further details, please view the full Drug Safety Update here.

The post MHRA Drug Safety Update: Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs appeared first on Community Pharmacy England.