Paxil Timeline

1992—GlaxoSmithKline (GSK) puts Paxil on the market; it proceeds to become one of the most-prescribed drugs for treating depression and a plethora of anxiety disorders.

1999—Reynaldo Lacuzong, a man with no prior history of serious mental illness, violence or thoughts of suicide, is prescribed 10 mg of Paxil. He almost immediately becomes agitated and hyperactive. On his third day of taking Paxil, Lacuzong drowns himself and his two small children in a bathtub.

June 2003—The FDA warns against prescribing Paxil to children and adolescents because of the link between Paxil and suicide in patients under 18 years old.

February 2004—Leaked documents show that, as early as 1998, GSK knew Paxil was not effective in helping relieve depression in children.

March 2004—FDA places “black-box” notice on SSRIs and other antidepressants, warning of their tendency to cause suicidal thoughts in children and adolescents.

May 2004
—FDA instructs analyst to censor data on Paxil and other antidepressants before Congressional meeting; legislators accuse agency and GSK of obfuscating risks.

June 2004—GSK is sued for lying about safety and effectiveness of Paxil.

August 2004—As part of lawsuit settlement, GSK agrees to publish results of clinical tests on Paxil.

August 8, 2005—Paxil Protest website is launched. It receives 250,000 hits in first three weeks but is soon taken down as part of confidentiality agreement into which owner entered as part of settlement of his legal action against GSK.

September 2005—GSK issues “dear doctor” letter about Paxil and attendant risks of congenital heart defects.

December 8, 2005—Swedish study shows that women who took Paxil in early pregnancy were twice as likely to have babies with cardiac birth defects, as compared with the general population.

July 28, 2006—Texas couple files suit against GSK, alleging that the mother’s use of Paxil during pregnancy caused their infant to be born with heart defects that required multiple surgeries and implantation of a pacemaker.

October 2006—GSK agrees to pay $63.8 million in class action lawsuit over claims it promoted Paxil for use by children, while withholding unflattering information about the drug’s safety and effectiveness.

December 1, 2006—American College of Obstetricians and Gynecologists advises that Paxil be avoided “by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.”

March 2007—GSK pays $14 million to settle lawsuit over allegations of improperly seeking to delay introduction of generic competitors to Paxil.

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