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 Therapeutic Goods Administration (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. Pregabalin is marketed in Australia under the brand name Lyrica and various generic brands. Gabapentin is marketed under the brand name Neurontin, as well as various generic brands.
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.
A PI is a document that has been written by the pharmaceutical company responsible for the medicine (known as the 'sponsor') and has been approved by the Therapeutic Goods Administration (TGA). It provides objective information about the quality, safety and effectiveness of the medicine, and is intended to assist doctors, pharmacists and other health professionals in prescribing and dispensing the medicine. Similarly, a CMI contains information on the safe and effective use of a medicine for consumers. PI and CMI for all prescription medicines included on the Australian Register of Therapeutic Goods are freely available on the TGA website.
Boxed Warnings are special warnings of potential serious side effects that the TGA sometimes requires sponsors to put prominently at the beginning of PI and CMI to help manage those risks.
TGA investigation
The 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
