Did you, or a family member develop Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) after taking prescription Lamictal? Lamictal, also known by its generic name Lamotrigine, is an anti-convulsant epilepsy drug used to treat symptoms of epilepsy and bipolar disorder, but studies show a strong link between the use of Lamictal and adverse events such as birth defects, aseptic meningitis, suicidal thoughts, “angry” or severe rashes, anxiety, and Stevens-Johnson Syndrome.
Lamictal side effects have been added to the drug’s labeling in a Black Box Warning as far back as March 1997. If you took Lamictal and experienced these adverse effects, please contact us to discuss your potential litigation and address any questions you have with our attorneys.
Manufactured by pharmaceutical giant GlaxoSmithKline, Lamictal first received Food & Drug Administration (FDA) approval in 1994. The drug was approved for the treatment of seizures and similar symptoms associated with epilepsy. Lamictal works as a sodium channel blocker by inhibiting voltage-sensitive sodium channels into the body. Despite its purported benefits, adverse events reported by Lamictal users, such as severe and potentially fatal skin rashes, lead the FDA to issue a Black Box Warning advising potential consumers about the risks associated with the use of this drug. In their advisement, the FDA warned about a range of hypersensitivity reactions that can occur in Lamictal users. A hypersensitive reaction occurs when a drug causes a user’s immune system to overreact, resulting in allergy or an adverse autoimmune response.
Lamictal is also prescribed off-label for the treatment of mood disorders. The drug is believed to be neuroprotective and is clinically effective at regulating and equalizing the drastic changes in mood associated with bipolar disorder and anxiety.
The FDA has identified risks associated with Lamictal withdrawal, which can occur when a Lamictal user attempts to wean him or herself off of the drug, or in the potentially life-threatening situation where a patient stops using Lamictal cold-turkey. Lamictal withdrawal symptoms are attributed to the increased accessibility of excitatory amino acids in the body that re-enter the brain synapse as the drug dosage is decreased. Symptoms associated with Lamictal withdrawal include withdrawal fatigue, mood disorders, rashes, and anxiety. Lamictal users with a history of seizures are at an increased risk of the recurrence of seizures during the discontinuation or step-down process.
Lamictal came under FDA scrutiny in 2006 after data garnered from the North American Antiepileptic Drug Pregnancy Registry suggested a possible association between exposure to lamotrigine monotherapy during the first trimester of pregnancy and cleft lip and/or cleft palate in newborn babies. Lamictal was included a 2009 FDA Postmarket Drug Safety statement concerning the purported link between suicidal behavior and the class of antiepileptic drugs of which Lamictal is a part. The FDA suggested that the risk of suicidal thoughts and ideation amongst antiepileptic drug users applied to all drugs of its class used for any indication.
In 2010, the FDA issued a Drug Safety Communication announcement for Lamictal, warning consumers that the drug could cause aseptic meningitis. Between the date of Lamictal’s FDA approval in December 1994 and November 2009, the FDA identified 40 cases of aseptic meningitis linked to use of the drug. The FDA revised the drug label’s “Warnings and Precautions” section to reflect information gathered about this risk. In conjunction with this updated label, the FDA urged Lamictal users to report to their medical care providers any symptoms of meningitis they experience while using the drug, such as a headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light.
In April of this year, The FDA issued an additional Drug Safety Communication for Lamictal, warning consumers that the drug can cause a serious and life-threatening immune system reaction in users. This over-reaction in the immune system, called hemophagocytic lymphohistiocytosis (HLH), can lead to severe inflammation, fever, and rash. Symptoms of HLH include:
The FDA urged medical care providers to monitor patients for 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, GSK recalled two batches of Lamictal 200mg tablets in the United Kingdom after the discovery of an issue related to delayed dissolution. The 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 tablet was deemed unlikely to impact plasma concentrations in patients who had already taken pills from the impacted batches. However, there was an appreciable risk of a reduction in efficacy in these batches. The batch affected by the recall expired in August 2013; no other lot of the GlaxoSmithKline-made Lamictal 200mg tablets, dose forms, and the overall strength of Lamictal drug stand impacted by this issue.
Studies have suggested a link between use of Lamictal and contraction of Stevens-Johnson Syndrome (SJS). SJS is a severe rash that can travel through the mucous membranes in the body and is often deadly. Symptoms of SJS usually begin with a fever and sore throat, accompanied by blistering, lesions, and ulcers on the mouth, lips, and in the genital area. Symptoms and adverse events associated with SJS include:
Use of Lamictal is also linked to Toxic Epidermal Necrolysis (TEN), a similarly life-threatening rash that leads to the top layer of skin to blister and peel off in large sheets. SJS and TEN are different names for similar diseases. SJS involves 10% of the skin or less, and the risk of death is 5-15%. In comparison, TEN affects over 30% of the skin, and at least one-third of patients die. Many survivors suffer disability, blindness, or disfigurement. The risk of SJS increases for patients on Lamictal who are also taking valproic acid, another anti-seizure medication, as part of their treatment regimen. This combination of drugs increases the amount of active Lamictal in the bloodstream, which in turn increases the risk of allergic reactions, rashes, and SJS. The FDA strongly urges medical care providers and users to discontinue use of Lamictal at the first sign of an outbreak, which typically precipitates the other symptoms as mentioned above.
The FDA required the addition of a Black Box Warning, the administration’s strongest warning, on Lamictal’s label in 2015 to warn users about potentially life-threatening and fatal cases of SJS and TEN from Lamictal use. The Black Box Warning states that it is critically essential for Lamictal users to look for any signs of a rash on their bodies and to seek immediate medical treatment should a rash develop.
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