In September 2011, a study was conducted that showed that the antiepileptic drug Lamictal was more dangerous to unborn babies than previously thought. Lamictal is manufactured by the global healthcare company, GlaxoSmithKline, and has been linked to numerous dangerous side effects, including birth defects. Prior to 2011, the FDA had stated that the pregnancy risk class of Lamictal was a Category C (no known human risk), however, they moved the drug to Category D (positive evidence of human fetal risk) at this point. While Lamictal is commonly prescribed to both children and adults, including pregnant women, there have been numerous cases over the last several years that have raised questions about its safety. Because of this, the FDA encourages women who are prescribed Lamictal while pregnant or who have been taking the drug prior to their pregnancy to consult their doctor and pursue other options.
One of the most common birth defects associated with Lamictal is a cleft palate, which occurs when an opening in the roof of the mouth in which the two sides of the palate do not join together. This happens in utero as the baby develops. If your child was born with a cleft palate and you were on the anticonvulsant drug Lamictal, please contact Wormington & Bollinger today. Our knowledgeable Lamictal lawyers will go over your case and determine whether or not you have the right to pursue legal action against GlaxoSmithKline.
Lamictal and Cleft Palates
Cleft palates occur early in pregnancy and the majority of clefts tend to be due to a combination of genetics and environmental reasons. However, cleft palates have also been linked to the use of Lamictal by the mother during pregnancy in recent years. Statistics show that there is a correlation between taking Lamictal during the first trimester of pregnancy and an increased risk of cleft palate or lip in the child. In a 2008 study, there were three cases of cleft palate and two cases of cleft lip in infants born to 564 Lamictal users, which comes out to be a rate of 8.9 per 1,000.
If you are currently taking Lamictal and are either pregnant or planning a pregnancy, please alert your doctor right away. While immediate stoppage of Lamictal is not recommended, there are other drug options out there that may be safer.
Causes of Cleft Palates
Cleft palates oftentimes occur in conjunction with other syndromes or birth defects, however, they can also show up on their own. In many cases, these birth defects occur because of mutant genes inherited by one or both parents, viruses, or drugs, such as Lamictal.
Symptoms of Cleft Palates
The following are some of the most common symptoms of a cleft palate
- Separation of the palate
- Nasal distortion
- Ear infections
- Inability to gain weight
- Nasal regurgitations
- Growth retardation
- Misaligned teeth
- Feeding problems
- Poor teeth
If you or a loved one has given birth to a child with a birth defect such as a cleft palate while on Lamictal, please contact Wormington & Bollinger today.