The anticonvulsant lamotrigine—sold under the brand name Lamictal—has been identified as a potential cause of disfiguring birth defects, meningitis, and suicidal thoughts.
What Is Lamictal? When Is It Prescribed?
Lamictal is the brand name for the drug lamotrigine. Made and sold by British pharmaceutical giant GlaxoSmithKline, this prescription medication is used as a standalone epilepsy treatment in those aged 16 and up and as an adjunctive epilepsy and Lennox-Gastaut syndrome therapy in those aged two and up. Doctors can also prescribe it for treatment of Bipolar I Disorder. The U.S. Food and Drug Administration ( FDA) first approved Lamictal in December 1994. GlaxoSmithKline sells it in oral tablets ranging from 25 mg to 200 mg lamotrigine; GSK sold 46 million Lamictal prescriptions between 1994 and 2009.
Scientists are unsure of Lamictal’s mechanism of action. The most prominent theory suggests that the drug inhibits voltage-sensitive sodium channels, which prevents the release of two amino acids: glutamate and aspartate. It does not inhibit acetylcholine or GABA release like other anticonvulsants such as valproic acid.
Lamictal Side Effects Include Birth Defects and Meningitis
In September 2006, the FDA sent a Lamictal alert to healthcare professionals advising them that data from the North American Antiepileptic Drug Pregnancy Registry (NAAED) found a link between Lamictal use and birth defects. Specifically, women who used Lamictal in the first three months of their pregnancies were more likely to give birth to children with cleft lips and cleft palates than the general population.
The NAAED Registry found that 564 women using Lamictal gave birth to children with oral clefts, amounting to a calculated prevalence of 8.9 children with oral clefts per thousand users. By contrast, women taking neither Lamictal nor any other antiepileptic give birth to children with oral clefts at a rate of only 0.5 to 2.16 per thousand, according to other data. The FDA considered these findings merely preliminary, but in July 2011, the medical journal The Lancet found a correlation between high doses of antiepileptics and birth defects.
The FDA-mandated Lamictal label does not contain a “Pregnancy” entry in its “Warnings and Precautions” section. The label does indicate that Lamictal is classified as a “Pregnancy Category C” drug, however, meaning that some birth defects appeared in Lamictal studies involving animals as test subjects.
In August 2010, the FDA released a Lamictal warning in the form of a Drug Safety Communication informing the public that Lamictal can cause aseptic meningitis, a form of meningitis not caused by bacterial infection. Viruses, other non-bacterial infections, toxic agents, vaccines, malignancy, and some medications are often responsible for inflaming the meninges, the membrane that protects the brain and spinal cord. Symptoms of aseptic meningitis include:
- stiff neck
- abnormal sensitivity to light
The FDA identified 40 cases of aseptic meningitis between the date of the drug’s approval in December 1994 and November 2009. According to the FDA’s data summary, symptoms occurred between one and 42 days after beginning Lamictal treatment, with the average onset beginning on day 16. One of the forty died (though, according to the FDA, the death was not due to aseptic meningitis). Thirty-five of the 40 required hospitalization, though—in most cases—the symptoms resolved themselves after the patients discontinued Lamictal. Fifteen people who resumed taking Lamictal experienced more severe aseptic meningitis symptoms between 30 minutes and 24 hours. The FDA noted that symptoms involving other organs, particularly the kidneys, meant that Lamictal aseptic meningitis may be related to hypersensitivity or a generalized drug reaction.
As a result of these findings, the FDA added an “Aseptic Meningitis” entry to the “Warnings and Precautions” section of Lamictal’s label.
Lamictal Might Cause Suicidal Thoughts
In January 2008, the FDA issued a Drug Safety Communication concerning a tendency of all antiepileptic drugs: they have the potential to cause users to have suicidal thoughts. By late 2008, the FDA required that antiepileptic manufacturers include warnings about these tendencies on the drugs’ labels. The warning is based on a meta-study of 199 placebo-controlled clinical trials. The antiepileptic users who participated in the trials experienced suicidal thoughts at double the rate of the placebo population (0.43% vs. 0.24%). Due to the dangers antiepileptic drugs place on users, the FDA added a “Suicidal Behavior and Ideation” entry to the “Warnings and Precautions” section of Lamictal’s label.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that getting satisfaction shouldn’t be just more hardship. That’s why we do everything we can to streamline the process of helping victims get the compensation they deserve.
If you have taken Lamictal and you believe that you or your child experienced adverse side effects as a result, contact RLG today.