Lamictal

GlaxoSmithKline developed Lamictal, and the U.S. Food and Drug Administration approved it in 1994.

Even though it’s only approved for epilepsy and as maintenance medicine to delay mood episodes in people with bipolar I, some medical providers prescribe it to treat other conditions off-label — uses not approved by the FDA.

Lamictal XR, the extended-release version of Lamictal, is not approved for patients younger than 13. It’s only approved for treating certain types of seizures.

In January 2020, Taro Pharmaceuticals, a manufacturer of generic Lamictal, issued a recall for one lot of lamotrigine because it was contaminated with a small amount of enalapril maleate — a blood pressure and heart failure drug that may cause birth defects.

Researchers in 2022 published results on a generic version of extended-release lamotrigine and found the drug to be bioequivalent to the brand name medication.

Researchers believe Lamictal works by slowing down electrical signals and inhibiting certain chemicals in the brain that cause brain cells to signal too quickly. When brain cells work too fast, it causes seizures. By slowing down these brain signals, lamotrigine may help to reduce seizure episodes.

In people with bipolar disorder, the medication helps to reduce mood swings, though researchers aren’t sure how the drug actually works.

Recommended Dosages

Lamictal comes in several forms and strengths. Depending on the reason for treatment, the recommended dosage is different.

Patients typically take Lamictal once or twice a day, and it can be taken with or without food. If taking Lamictal XR, make sure to take the pills whole and don’t crush, cut or chew them.

The medication starts at a low dose. Then, the dose gets higher over the course of several weeks. People who are taking the drug with other drugs for seizures take lower doses. They may take it every other day when beginning treatment.

Researchers studied Lamictal in clinical trials that included thousands of patients in several groups. Across these studies, researchers defined common side effects as those that occurred in 10 percent or more of patients using the drug for epilepsy and five percent or more of patients using the drug for bipolar disorder.

The most common side effects in children were infection, vomiting, diarrhea, accidental injury, fever, abdominal pain and tremor.

In clinical trials, the most common side effects that caused people to drop out of the trial included: rash, headache, dizziness and impaired balance or coordination.

There have been reports of serious side effects linked to Lamictal, but these side effects are rare, according to the drug’s label. These range from serious skin rashes to death.

Skin Rashes

In clinical trials, 11 of 3,348 adults with epilepsy who received Lamictal had a serious rash that led to hospitalization and discontinuation. Researchers received postmarketing reports of rash-related deaths, but the numbers were too few to estimate the exact rate.

Serious rashes that led to hospitalization were: Stevens-Johnson syndrome — a serious, blistering rash — angioedema, toxic epidermal necrolysis and rashes associated with multiorgan hypersensitivity.

Hemophagocytic Lymphohistiocytosis (HLH)

HLH is a potentially life-threatening syndrome caused by overactivation of the immune system. The overactivation causes severe inflammation throughout the body. In April 2018, the FDA released a warning that Lamictal can cause HLH.

HLH usually starts with a high fever and rash. It causes problems with blood cells and internal organs such as the lungs, kidneys and liver. It usually starts within 8 to 24 days after starting treatment.

Multiorgan Hypersensitivity Reactions and Organ Failure

Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred. This is a potentially fatal drug reaction.

Symptoms include fever, rash, and other organ problems. It sometimes resembles a viral infection. Report these symptoms to your medical provider right away.

Blood Problems

Some people who took Lamictal had abnormal blood cell counts such as neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, and, rarely, aplastic anemia and pure red cell aplasia.

Suicidal Thoughts or Behaviors

Taking Lamictal may increase the risk of suicidal thoughts or behaviors. In studies of anti-epileptic drugs (AED) such as Lamictal, patients who took one type of drug had about twice the risk of suicidal thoughts and behaviors compared to people who took a placebo. These symptoms may start as early as one week after starting treatment.

Aseptic Meningitis

Taking Lamictal increases the risk of aseptic meningitis — inflammation of the membrane covering the spinal cord and brain. Symptoms include rash, fever, vomiting, nausea and stiffness and soreness in the neck. Symptoms usually appear anywhere from one day to about a month after starting therapy.

Withdrawal Seizures

Patients taking Lamictal should not abruptly stop treatment. Patients with epilepsy may experience an increase in seizure frequency and people with bipolar disorder may develop seizures. Slowly weaning off the drug for at least two weeks is recommended.

Lamictal’s drug label lists several drugs that may increase or decrease the drug’s blood concentration. This could lead to less effective medication or an increase in side effects if the concentration is too high.

This is not a complete list of potential drug interactions. Make sure you tell your medical provider about all medications, supplements and herbs you take.

Make sure you talk to your medical provider about any allergies you have, medications you take or preexisting health conditions. Lamictal might not be safe or effective for everyone.