Zoloft is manufactured by pharmaceutical giant Pfizer. It was approved by FDA in 1990 for treatment of major Depressive Disorder, Obsessive Compulsive Disorder (OCD), Panic Disorder, Post Traumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD) and Social Anxiety Disorder.

Sertraline is the main active ingredient of Zoloft. Sertraline was first developed in 1970s by Pfizer. Zoloft was presented for FDA approval in 1990 and was approved for many mood and stress related disorders.

FDA was having a close review related to results of antidepressant studies including Zoloft in children, since June 2003. The Food and Drug Administration issued a Public Health Advisory on the use of popular antidepressants including Zoloft by children and adults. It cautioned physicians, their patients, and families and caregivers of patients to closely monitor both adults and children with depression, especially at the beginning of treatment and change of dosages.

FDA’s Psychopharmacologic Drugs and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees held a meeting on February 2, 2004. The advisory committee came with an advice of changing the label of drug to highlight the need of monitoring patients being treated with certain antidepressants such as Zoloft. FDA accepted these recommendations in its following advisory.

FDA issued a Public Health Advisory to update patients and healthcare providers with the latest information on use of anti depression drugs including Zoloft in 2005. It was in wake of scientific publications that revealed the possibility of increased risk of suicidal behavior in adults treated with antidepressants. The FDA asked manufacturers to provide information from their trials related to side effects of the drugs.

FDA also notified healthcare professionals about the antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidal thinking or behavior in adults being treated with antidepressant medications in the same year.

The FDA had issued reports related to an increased risk of persistent pulmonary hypertension (PPH) in children born to mothers taking antidepressants during pregnancy and the risk of serotonin syndrome with the use of anti depression drugs like Zoloft in 2006.

After going through close review study on anti depression drugs like Zoloft, FDA issued warnings related to Zoloft’s along with other similar antidepressant medications risks of increasing suicidal thoughts and behavior in 2007. It advised physicians and families of patients taking antidepressants to closely monitor the person to ensure their safety.

FDA asked the manufacturers including Pfizer to put a “black box” warning informing on the label of drug related to increased risk of suicidal thinking and behavior in children on use of this drug to treat depression. A black box warning is the most stringent warning for medications by FDA. It is issued when drugs could cause the risk of a fatal or life-threatening side effects or permanent disability.

The FDA concluded that Zoloft is an unsafe drug and needs many precautions before using it. It is must to take precautions to ensure safety of patients. Medical practitioners should prescribe this medicine after evaluating its risk and benefits to the patient.