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.

Zoloft in the News:

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

Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, the FDA began a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:

• Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.
• Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.

These recommendations are consistent with existing warnings for treated adults in the approved labeling (package insert) for antidepressant medications that can be found at: http://www.fda.gov/cder/drug/antidepressants/PI_template.pdf The Healthcare Professional and Patient

Information Sheets for the antidepressant indications will be updated to add this information within the week. A list of drugs to be included in this update can be found at: http://www.fda.gov/cder/drug/antidepressants/antidepressantList.htm

FDA is working closely with the manufacturers of all marketed antidepressants to fully evaluate the risk of suicidality in adults treated with these drugs. The FDA has asked these manufacturers to identify all placebo-controlled trials conducted in adults in their development programs for their antidepressant products, regardless of the indication studied, and to provide information from these trials to FDA. Manufacturers are being asked to use a similar approach to assembling this information as was used in evaluating the risk of suicidality in placebo-controlled trials in pediatric patients treated with antidepressant medications. The method used to analyze the data for risk of suicidality in children using antidepressant medications is described in more detail at the following web page: http://www.fda.gov/cder/drug/antidepressants/default.htm. A similar approach will be used for adults.

FDA’s comprehensive review will involve many hundreds of individual clinical trials and many thousands of adult patients. It is expected that this review will require a year or more to complete because of the large number of trials and the thousands of adverse events that must be checked for possible evidence of suicidality. The FDA will make the results of its review available to the public once its analyses are complete, and will update this advisory in the meantime if more definitive information becomes available.

Register your Zoloft Case

If you or a loved one has suffered from the side effects of Zoloft, you may qualify for damages or remedies that may be awarded in a possible Zoloft class action lawsuit.