What has the FDA said about Paxil?
It compelled GSK to add a “black-box” warning to Paxil with information describing the increased risk of thoughts of suicide and behavior in children and adolescents taking antidepressants. In May 2006, GSK and the FDA announced labeling changes pertaining to younger adults. Two months later, the FDA issued two alerts related to Paxil. The first FDA alert was about the use of antidepressants such as Paxil during pregnancy in mothers of babies born with persistent pulmonary hypertension of the newborn (PPHN). The second FDA alert was about serotonin syndrome, which can occur when SSRIs (such as Paxil) and medicines used to treat migraine headaches are taken together.
