Other safety alerts
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| Australia: Pregabalin and gabapentin: Safety advisory: enhanced warnings relating to abuse and dependence |
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Therapeutic Goods Administration (TGA) announces that consumers and health professionals are advised that Boxed Warnings are being added to the Product Information (PI) and Consumer Medicine Information (CMI) for medicines containing pregabalin and gabapentin. The enhanced warnings advise that pregabalin poses a risk of misuse, while both pregabalin and gabapentin pose risks of abuse and dependence. These risks can lead to serious side effects, some of which can be life-threatening. The risks are higher if medicines that can make you sleepy (sedating medicines), including opioids, are used at the same time.
The Boxed Warnings added to pregabalin and gabapentin products advise prescribers to assess a patient's risk of misuse (for pregabalin), and abuse or dependence (for pregabalin and gabapentin) before prescribing these medicines, and to monitor them regularly during treatment. The decision to impose the Boxed Warnings has been taken after TGA investigation of continuing reports of misuse associated with pregabalin, and abuse and dependence associated with both pregabalin and gabapentin in Australia.
Pregabalin and gabapentin are used to treat neuropathic pain (pain caused by an abnormality of, or damage to, the nerves) and epilepsy. They may be used alone or in combination with other medicines. As with any medicine, health professionals and patients must assess the risk and benefits of using pregabalin and gabapentin based on the individual clinical situation. If, after consideration of the potential side effects associated with pregabalin and gabapentin, the decision is made to use these medicines, they should be used for as short a period as possible, at the lowest effective dose.
TGA investigated continuing reports of misuse associated with pregabalin, and abuse and dependence associated with both pregabalin and gabapentin in Australia and referred the issue to the independent Advisory Committee for Medicines for expert advice. The National Coronial Information System shows that deaths related to pregabalin rose from 16 in 2013 to 121 in 2016. A large majority of these deaths were unintentional. Additionally, a Medical Journal of Australia study of ambulance data in 2018 found a tenfold increase in the rate of pregabalin-related ambulance attendances since 2012, with patients frequently misusing pregabalin with other sedating medicines. On 19 Jan 2021, the TGA's Database of Adverse Event Notifications included 184 and 18 reports of suspected abuse, misuse or dependence with pregabalin and gabapentin products respectively. There were 111 fatal cases and 110 of these identified pregabalin as a suspected medicine.
Information for health professionals:
- Check for history of substance use disorder and signs of abuse or dependence before prescribing pregabalin or gabapentin.
- Monitor patients regularly during treatment, particularly among patients with current or past use of opioids and/or benzodiazepines. In particular, monitor for increases in dosing or drug-seeking behaviours.
- Caution is advised when prescribing pregabalin or gabapentin concomitantly with opioids due to risk of central nervous system (CNS) depression. Concomitant use of opioids may result in severe sedation, respiratory depression, coma and death. Patients who require concomitant treatment with CNS depressants, including opioids, should be carefully observed for signs of CNS depression, such as somnolence, sedation and respiratory depression. Limit dosages and durations to the minimum required to achieve the desired therapeutic effect.
- Withdrawal symptoms after discontinuation of both short-term and long-term treatment have been observed in some patients. The following events have been reported: insomnia, headache, nausea, anxiety, hyperhidrosis and diarrhoea. Discontinuation should be done gradually over a minimum of one week.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/pregabalin-and-gabapentin
In Hong Kong, there are registered pharmaceutical products containing pregabalin (52 products) and gabapentin (25 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reaction related to pregabalin (10 cases; of which one case is related to intentional overdose) and gabapentin (3 cases).
Related news on the risk of central nervous system (CNS) depression (including respiratory depression) associated with the use of pregabalin and gabapentin in combination with opioids, and misuse and abuse of the two drugs, was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 27 Oct 2017, with the latest update posted on 20 Dec 2019. Letters to inform local healthcare professionals were issued by the DH on 27 Oct 2017 and 18 Sep 2019.
In Dec 2017 and Jun 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that safety information on the risk of CNS depression with opioids should be included in pregabalin- and gabapentin-containing products. The risk of misuse and/or abuse and dependence of pregabalin and gabapentin is documented in overseas reputable drug references such as the “AHFS Drug Information" and “British National Formulary”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Monday, Feb 1, 2021
Issued at HKT 15:00
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