Paxil and the FDA: Warnings and the Safety Debate

Paxil (paroxetine) has been linked with a long list of dangerous health complications that ranged from minor to major among different patients. The drug’s tendency to induce increased suicidal thoughts and its addictive nature has forced FDA to think seriously about these issues. But the biggest concern was from the life threatening birth defects amongst infants born to women taking Paxil while they were pregnant. Paxil’s manufacturer, GSK, has faced heavy criticism for categorizing it as a non-habit forming drug and also for not issuing warnings regarding its addictive nature, withdrawal symptoms and complications.

Paxil as an antidepressant was approved by the FDA in 1992 to treat anxiety, depression, panic disorders, post traumatic stress syndrome, and obsessive-compulsive behaviors in patients above 18 years of age. At the time of approval, the FDA said that Paxil was ineffective in patients below 18 years of age, and could also cause severe complications and increased suicidal thoughts.

The safety of Paxil has been under considerable debate since many lawsuits have been filed which raised many questions about its safety and efficacy. The FDA has repeatedly required GSK to issued new warnings to inform patients about the various risks associated with Paxil intake.

In December 2005, the FDA issued a warning about birth defects reported in the infants of women who were taking Paxil during the first trimester of the pregnancy. Paxil is associated with an increased risk of congenital malformations linked particularly with cardiovascular defects. The FDA’s warning stated this clearly, finding that Paxil, like other drugs classified in the SSRI group, is highly likely to cause such defects.  The FDA urged that extra care be used before Paxil is prescribed to women who are pregnant or are breastfeeding.

Again in March 2006, the FDA issued another directive.  After thoroughly reviewing the effects of Paxil and other SSRIs on children, the FDA concluded that the use of Paxil can increase the risk of suicides significantly, especially among patients who were below 18 years of age.  A similar warning had been issued by the FDA in October 2003, but this weaker warning had gone unnoticed by the public. The FDA did not ban the prescription of Paxil in patients under 18 years old, but rather allowed GSK to rely on just issuing stronger warnings.

The FDA’s reports covered more than 8 antidepressant drugs including Paxil. The study was focused solely on prescriptions written by pediatricians or other doctors treating children. Although a thorough study was conducted, much of the discussion and the collected data was kept hidden from the public.  However, GSK publicized the portions of the studies that found Paxil to be helpful for the children.  Once this selective publication policy became known, it caused an uproar from scientists and consumer advocates alike.

In March 2004, the Food and Drug Administration issued further cautions to parents, healthcare professionals and families of adults and children planning to start Paxil. This was as a Public Health Advisory where FDA warned about the possible consequences and thus suggested that doctors thoroughly study a patient’s condition, age and health before prescribing Paxil.

It was clearly noted and warned by the FDA that patients taking antidepressants, both adult and pediatric, are vulnerable to worsening depression and increasing incidence of suicidal behavior upon intake of SSRI antidepressant drugs.

These warnings were too little, too late for those patients who had been taking Paxil for years. The patients who became victims of Paxil’s side effects were not aware of the damage and consequences this drug could cause in their lives.

The lawsuits filed by these victims has helped to make the public aware of the hazards and the consequences of Paxil and other SSRI drugs.