According to Bloomberg (11/03/11), negotiations regarding the settlement are not yet complete. Investigations into the company reportedly resulted in charges of off-label marketing (that is, marketing the drugs for uses not approved by the FDA) for several drugs and charges that the company defrauded the Medicaid program. According to reports, at least some of the investigation revolved around Paxil (Medical Marketing & Media; 11/07/11).
In 2010, GlaxoSmithKline reportedly paid more than $1 billion to settle lawsuits alleging infants who were exposed to Paxil prior to birth had an increased risk of birth defects than infants not exposed to the medication. Some Paxil birth defects lawsuits are still pending, although GlaxoSmithKline is reportedly in the process of settling those cases.
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Paxil birth defects lawsuits alleged that infants who were exposed to Paxil prior to birth were at an increased risk of side effects such as persistent pulmonary hypertension of the newborn (PPHN). Recent studies have also reportedly suggested a link between the use of selective serotonin reuptake inhibitors (SSRIs)—a class of antidepressant that includes Paxil—and an increased risk of autism spectrum disorder and other birth defects.
One study, published online in the Archives of General Psychiatry (07/11), found that mothers who used SSRI medications during the 12 months prior to delivery had around two times the risk of having a baby diagnosed with autism than mothers who did not use the antidepressants prior to delivery.