The Food & Drug Administration warns that the use of Lamictal for treatment of epileptic or bipolar disorders may put patients at risk of Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, life-threatening rashes
If you or a family member developed Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) after taking prescription Lamictal, you might have legal recourse. Lamictal, also known by the generic name Lamotrigine, is an anticonvulsant drug used to treat symptoms of epilepsy and bipolar disorder. Medical studies show a strong link between the use of Lamictal and adverse events including birth defects, aseptic meningitis, suicidal thoughts, severe rashes, anxiety, and Stevens-Johnson Syndrome. As far back as March 1997, the drug’s label has included a Black Box Warning concerning side effects associated with Lamictal use. If you or a loved one took Lamictal and experienced these adverse effects, please contact us to discuss your potential litigation and address any questions you have with our attorneys.
Lamictal: Drug Uses and Side Effects
Lamictal, which is manufactured by pharmaceutical giant GlaxoSmithKline, first received Food & Drug Administration (FDA) approval in 1994. Lamictal was initially approved for the treatment of seizures and other symptoms associated with epilepsy. The drug works as a sodium channel blocker and inhibits voltage-sensitive sodium channels from entering the body. In spite of its alleged benefits, adverse events reported by Lamictal users, which include severe and potentially fatal skin rashes, resulted in an FDA-mandated Black Box Warning advising potential consumers about the dangers associated with the use of this drug. In their warning, the FDA described a range of hypersensitivity reactions that can occur in Lamictal users. A hypersensitive response occurs when a drug such as Lamictal causes a user’s immune system to overreact, which results in an allergic reaction or an adverse autoimmune response.
Lamictal is often prescribed “off-label” for the treatment of mood disorders such as bipolar disorder and anxiety. Lamictal is believed to be neuroprotective and clinically effective at regulating or equalizing the drastic swings in mood associated with these mood disorders.
Lamictal withdrawal can occur when a Lamictal user attempts to wean him or herself off of the drug, or in the potentially fatal situation where a patient stops using Lamictal all at once, or “cold-turkey.” According to the FDA, Lamictal withdrawal symptoms stem from the increased accessibility of excitatory amino acids in the body that later re-enter the brain as the drug’s dosage is decreased. The symptoms associated with Lamictal withdrawal may include withdrawal fatigue, mood disorders, rashes, and anxiety. Lamictal users with a history of epileptic seizures are at an increased risk of the recurrence of seizures during the discontinuation or step-down process.
Lamictal Warnings and FDA Action
Lamictal fell under FDA scrutiny back in 2006, after data gathered from the North American Antiepileptic Drug Pregnancy Registry indicated that there was an association between exposure to Lamictal mono-therapy during the first trimester of pregnancy and incidents of cleft lip or cleft palate in infants. Lamictal was directly implicated in a 2009 FDA Postmarket Drug Safety statement regarding the alleged link between suicidal behavior and the class of antiepileptic drugs of which Lamictal is a part. In its report, the FDA suggested that the risk of suicidal thoughts and actions among antiepileptic drug users applied to all drugs of its class used for any indication.
More recently, the FDA issued a Drug Safety Communication update for Lamictal in 2010, warning consumers that use of the drug could cause aseptic meningitis. Between the date of the drug’s FDA approval in December 1994 and November 2009, the FDA identified 40 cases of aseptic meningitis linked to use of Lamictal. The FDA required a revision to the drug label’s “Warnings and Precautions” section to reflect information garnered about this risk. In addition to this updated label, the FDA urged Lamictal users to report any symptoms of meningitis they experience while using the drug, such as a headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light immediately to their healthcare providers.
Dangerous and Potentially Life-Threatening Side Effects Identified in 2018
In April 2018, the FDA issued an additional Drug Safety Communication for Lamictal, warning potential users that use of the drug can cause a severe and life-threatening immune system reaction in users. This over-reaction in the immune system, known as hemophagocytic lymphohistiocytosis (HLH), can lead to chronic pain and severe inflammation, fever, and rash. Symptoms of HLH include:
- Persistent fever (greater than 101 degrees)
- Rash (severe or “angry” rash)
- Liver enlargement
- Low platelets
- Low white blood cells
- Respiratory issues
- Yellowing of the skin or eyes
- Unusual bleeding
- Trouble walking
- Difficulty seeing
- Visual disturbances
- Swollen or painful lymph nodes
The FDA urged medical care providers to monitor patients suffering from these symptoms of persistent high fever and rashes on the body, as HLH can occur within days to weeks after the onset of use. If not treated, HLH can result in severe problems with organs including the liver, kidneys, and lungs.
In 2011, GlaxoSmithKline (GSK) recalled two different batches of Lamictal 200mg tablets in the United Kingdom, due to the discovery of an issue related to the delayed dissolution of the tablets. The UK’s Medicines and Healthcare Products Regulatory Agency issued a Class 2 Drug Alert, requiring pharmacy recall of the prescriptions within 48 hours.
The delayed dissolution of the Lamictal 200mg tablets was deemed unlikely to impact plasma concentrations in patients who had already taken tablets from the impacted batches. However, the Medicines and Healthcare Products Regulatory Agency found that there was an appreciable risk of a reduction in efficacy in the impacted quantities. The quantities affected by the recall expired in August 2013; according to UK health officials, no other batch of the GlaxoSmithKline-made Lamictal 200mg tablets, dose forms, and the overall strength of Lamictal drug remain impacted by this issue.
Lamictal and Stevens-Johnson Syndrome (SJS)
Recent medical studies suggest a link between the use of Lamictal and contraction of Stevens-Johnson Syndrome (SJS). SJS is a severe rash that travels through the mucous membranes in the body and is often life-threatening. Symptoms of SJS typically begin with a fever and sore throat, accompanied by blistering, lesions, and ulcers on the mouth, lips, and in the genital area. Symptoms and side effects associated with SJS include:
- Flu-like sickness
- Skin rash that spreads across the body
- Inflammation of mucous membranes
- Persistent fever
- Skin Lesions
- Sore mouth and throat
- Vision loss or blindness