Pregabalin and gabapentin are to have enhanced warnings added to the Product Information (PI) and Consumer Medicine Information (CMI) to advise about the risks of misuse.
The TGA is adding Boxed Warnings to advise that pregabalin poses a risk of misuse, while both pregabalin and gabapentin pose risks of abuse and dependence.
The products are indicated for neuropathic pain and epilepsy, have previously raised concerns about risks for misuse and addiction.
Prescribers are advised in the new warnings to assess a patient’s risk of misuse before prescribing pregabalin and to 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,” the TGA advises health professionals.
The TGA also advises caution when prescribing pregabalin or gabapentin concomitantly with drugs such as opioids due to risk of CNS depression