Zoloft (Sertraline) is the world’s most popular antidepressant. This pharmaceutical drug is produced and marketed by Pfizer and prescribed to patients with varying levels of anxiety and depression. It is classified as a selective serotonin reuptake inhibitor (SSRI) and currently used to treat social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, and other similar mental disorders for adults and children as young as six years old.

Over the past few years, Zoloft has been linked to patient reports of increased depression and suicidal behavior. Several drug advisory committees including the Food and Drug Administration (FDA) and the Psychopharmacological Drugs Advisory Committee (PDAC) continue to investigate these claims.

Pfizer began marketing the Zoloft in 1992. Today, Zoloft generates $2 billion dollars in annual sales and is among Pfizer’s top selling drugs. It is prescribed to both adult and pediatric patients and marketed as a versatile drug that can treat six mood and anxiety disorders, psychiatric and non-psychiatric disorders.

Since the early 1990s numerous world class experts have warned about the role of SSRI-induced akathisia in violence and suicide. On March 19, 1996, the FDA wrote to Pfizer stating: “We note that there appears to be an increased frequency of reports of suicidality in the pediatric/adolescent patients exposed to Sertraline [Zoloft] compared to either placebo or Sertraline-treated OCD patients. If this is in fact the case what would be a plausible explanation?”

In February 2004, the FDA announced a request to the manufacturers of ten antidepressant drugs, including Pfizer for Zoloft, that they strengthen the “Warning Label” to encourage close observation for worsening depression or the emergence of suicidal thinking and behavior.

Recently the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory on Zoloft: “Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications…Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. FDA has approved Zoloft for use in children only if they have obsessive-compulsive disorder.”

Patients taking Zoloft are reminded to seek professional medical advice regarding any adverse drug side effects or reactions. Patients should also realize that it could be dangerous to stop taking prescription medication, especially abruptly, and should talk with their physicians first.

[MORE INFORMATION ON SSRI ANTIDEPRESSANTS]

Zoloft in the News

The FDA updates warning against Zoloft drug side effects. (Jul-08-05) [FDA]

Public Health Advisory issued by the FDA to warn patients taking antidepressant medications. (Jun-30-05) [FDA]