A recent registry of 564 pregnant women who took Lamictal during their first trimester showed that five women gave birth to babies with cleft lip or cleft palate -- a gap in the upper lip or roof of the child's mouth. The FDA recently posted a safety alert on its website warning that women who are pregnant and taking Lamictal should consult with their doctor, though the agency says more verifiable data is needed to prove the connection. The alert noted that similar registries had not recorded such a high rate of cleft lip and palate incidences in the past.
FDA critic and nutrition author Mike Adams says the FDA is dragging its feet in pulling a potentially dangerous drug off the market. "That the FDA continues to allow psychotropic drugs to be prescribed to expectant mothers is an outrage," Adams said.
British drug giant GlaxoSmithKline says it learned of the registry's results in December 2005, when it notified the FDA of the problem. In June of this year, Glaxo sent a letter to doctors explaining the registry's findings.
"What the North American registry found hasn't been replicated by other pregnancy registries," said Holly Russell, director of product communications for Glaxo. "It's FDA's position as well as our own that without confirming data the important thing is to continue to monitor data from ongoing pregnancy registries and other sources."
GlaxoSmithKline announced last week that the FDA had recently approved Lamictal -- which brought in profits of $1.34 million for the company last year -- for treating epilepsy patients who suffer grand mal seizures, in addition to treating other epileptic disorders and bipolar disorder.
However, Adams says all consumers taking the drug should be aware of potential dangers, especially pregnant women or women who may become pregnant. "These drugs cause permanent harm to the fetus, resulting in birth defects, stunted development and enormous future health care costs," he said.