Pregabalin (pre GAB a lin) has been approved by the FDA to treat focal-onset seizures in patients 1 month or older.
Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.
Pregabalin is available as a capsule, extended-release tablet, or oral solution. The capsule is taken whole, with or without food while the extended-release tablet must be taken whole after your evening meal.
If you are allergic to pregabalin or any of the inactive ingredients, then you should not take it.
Other considerations may influence whether you should take pregabalin. Tell your healthcare provider if you:
Do not stop taking pregabalin suddenly unless directed to do so by your healthcare provider.
As with all antiseizure medications, pregabalin should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using pregabalin suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking pregabalin with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: angiotensin-converting enzyme (ACE) inhibitors, rosiglitazone or pioglitazone, any narcotic pain medicine, or tranquilizers or medicines for anxiety.
At this time, there is not enough evidence regarding developmental risks associated with the use of pregabalin in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.
If you become pregnant while taking pregabalin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
Pregabalin is present in breast milk. It is unknown if there are effects on the breastfed infant, or if pregabalin impacts milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for pregabalin and the potential effect on the infant from pregabalin or from your epilepsy.
There are no known effects of pregabalin on people who can become pregnant and fertility, but there has been a clinical trial which reported some negative effects on spermatogenesis (producing sperm).
Pregabalin is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by pregabalin can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.
The most common side effects that were reported in studies of pregabalin are: dizziness, drowsiness (somnolence), dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention) in adult patients, and increased weight and increased appetite in pediatric patients for the treatment of focal-onset seizures.
Studies have found that people who take antiseizure medications including pregabalin may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.
Angioedema (e.g., swelling of the throat, head, and neck) can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in these cases.
Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue pregabalin immediately in these cases.
Breathing problems may occur with pregabalin when used at the same time with CNS depressants, including opioids, or in the setting of underlying respiratory impairment. Be observant of the symptoms and note that your dosage may need adjusting.
Pregabalin may cause dizziness or drowsiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how pregabalin affects you.
Do not drive or operate machinery until you have gained sufficient experience on pregabalin to gauge whether it adversely affects your abilities.
Pregabalin may cause water retention and swelling (peripheral edema). Exercise caution when taking pregabalin and thiazolidinedione antidiabetic drugs together.