No Paxil Recall by FDA

Shortly after the release of the Public Health Advisory, FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of Paxil labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The Paxil warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

In June 2004, New York Attorney General Eliot Spitzer filed a lawsuit accusing GlaxoSmithKline of burying several studies that indicated Paxil was ineffective in the treatment of children and adolescents and may increase suicidal thoughts. The lawsuit, filed in New York State Supreme Court, also accuses Glaxo officials of misrepresenting data on the prescribing of Paxil to children.In response to the lawsuit, Glaxo the makers of Paxil, published the results of nine pediatric trials showing Paxil is mostly ineffective in treating children and may actually increase the risk of suicidal tendencies.

In September 2005, the FDA issued a Paxil warning detailing the results of a study that linked Paxil to birth defects. An increased number of women taking Paxil during the first trimester of pregnancy, compared with women using other antidepressants, reportedly had babies born with birth defects, including heart problems.