FDA Approves Zoloft For Post-traumatic Stress Disorder

NEW YORK -- December 8, 1999 –

Pfizer Inc. has received approval from the U.S. Food and Drug Administration for its anti-depressant, Zoloft® (sertraline hydrochloride), for treatment of posttraumatic stress disorder (PTSD).
A selective serotonin reuptake inhibitor discovered and developed by Pfizer, Zoloft is the first medicine to receive a FDA approval for the treatment of PTSD. Symptoms of PTSD may develop following any extreme traumatic event in which there was threatened death or serious injury, and the individual's response involved intense fear, helplessness or horror. Such events may include physical and sexual abuse and natural disasters.
Approximately 50 percent of the general population are exposed to a traumatic event during their lifetime. Ten to twenty percent of those develop PTSD. The prevalence of PTSD is twice as high in women as in men.
Symptoms can include persistent intrusive thoughts of the event, flashbacks, overall emotional numbness, or being easily startled.
"Patients suffering from PTSD experience significant distress or impairment in normal functioning," said Dr. Joseph Feczko, Senior Vice President, Pfizer Inc. "In clinical trials, Zoloft was shown to have considerable impact on these symptoms, thus giving physicians a new treatment option for this major medical need."
"Pfizer's commitment to innovative research and development is reflected in the approval of Zoloft for the treatment of PTSD," said Karen Katen, President, U.S. Pharmaceuticals. "In an effort to improve the quality of life of those suffering from this debilitating illness, we intend to launch a broad-based campaign to educate and increase awareness among health care professionals and consumers that PTSD is a treatable medical condition."
Zoloft is currently indicated for major depression, panic disorder, and obsessive-compulsive disorder. More than 100 million prescriptions for the medicine have been written in the United States since its launch in 1992.
Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) and a MAOI is contraindicated for at least 14 days after discontinuation of Zoloft. MAOI's are usually used to treat depression and related conditions. A patient should never take Zoloft while taking MAOI's. The most common side effects of Zoloft include nausea, insomnia, diarrhea, ejaculation problems (mainly ejaculatory delay) and somnolence