JAMP Pharma Corp. says it is recalling one lot of its pregabalin pain medication because some bottles labelled to contain 50-milligram capsules may contain 150-milligram capsules instead.
The mislabelled product could lead to patients receiving a much larger dose than prescribed, which could result in an overdose and “pose serious, potentially fatal health risks,” Health Canada said in a public advisory.
JAMP-Pregabalin is a prescription drug used in adults to treat pain caused by nerve damage due to diabetes, shingles or spinal cord injury, as well as pain associated with fibromyalgia.
Symptoms of pregabalin overdose may include sudden mood changes, sleepiness, confusion, depression, agitation, restlessness and seizures, the regulator said.
Taking too much pregabalin while also taking drugs that act on the central nervous system, including opioids, has been associated with heart electrical problems, like arrhythmia, as well as seizures and death.
Health Canada said if you think you are experiencing symptoms of an overdose, seek immediate medical attention.
Patients should not abruptly stop taking pregabalin, as this may result in withdrawal symptoms, including insomnia, nausea, headache, anxiety, excessive sweating, diarrhea and convulsions.
If you’ve been prescribed 50-milligram capsules and the bottle contains the higher dose, or if you are unsure, return it to your pharmacy, Health Canada advised. If you are unable to return your capsules to the pharmacy right away, talk to your pharmacist or doctor for further guidance.
The product was distributed nationally.
