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August 17, 2001
Pfizer Inc today announced that it has received U.S. Food and Drug Administration (FDA) approval for long-term use of Zoloft® (sertraline HCl) in the treatment of posttraumatic stress disorder (PTSD).
The new label for Zoloft indicates it is safe and effective in preventing relapse of PTSD and in sustaining symptom improvement over 28 weeks in both men and women.
The FDA granted the label change following review of the first-ever placebo-controlled study to examine the efficacy and tolerability of long-term pharmacotherapy of PTSD. Zoloft is currently the only medication approved for PTSD and is the most prescribed brand in the U.S. for the treatment of mood and anxiety disorders.
"This new study shows that patients can be maintained on Zoloft over the long term which is very significant given the high rate of relapse in PTSD patients and the fact that the average duration of the illness is at least several years," said Cathryn M. Clary, M.D., senior medical director, Pfizer. "Prior studies with Zoloft demonstrated the safety and efficacy of the product in the acute and continuation phases of treatment."
Posttraumatic stress disorder is a common psychiatric disorder, with prevalence rates higher than diabetes and asthma. In the U.S., one out of 13 individuals will experience PTSD at some point in their lives following exposure to an extreme traumatic event. The most common traumas associated with a risk for PTSD include experiencing sexual or physical assault, a serious accident or injury, and the sudden, unexpected death of a close friend or relative. Women are twice as likely as men to suffer from PTSD.
Zoloft's label change was based on a long-term study that involved PTSD patients who had previously responded during a 24-week open trial of Zoloft. The efficacy of Zoloft in maintaining a response in patients with PTSD was demonstrated for up to 28 weeks following this 24-week period. The study also demonstrated that both men and women maintained their treatment gains across the three core symptom clusters of PTSD: reexperiencing/ intrusion, avoidance/numbing and arousal. The new label recommends that patients should be periodically reassessed to determine the need for maintenance treatment.
Zoloft should not be taken together with monoamine oxidase inhibitors (MAOI), which are medicines used to treat depression and other conditions.
Some people taking Zoloft may have side effects. The most common side effects of Zoloft include upset stomach, having trouble sleeping, diarrhea, dry mouth, sexual side effects, feeling unusually sleepy or tired, tremor, indigestion, increase of sweating, feeling agitated, and decreased appetite. In clinical studies with Zoloft, few patients were bothered enough by side effects to stop taking their medicine.
As PTSD is a more common disorder in women than men, the majority of patients in the Zoloft clinical trials were women. Zoloft was effective in treating PTSD in the total population treated. Response rates were similar for men and women, but only women showed a significant difference versus placebo in the acute trials. While the clinical significance of this apparent gender interaction in the acute studies is unknown, Zoloft was found to be effective for both men and women in the longer term study in decreasing their risk for relapse.
Zoloft is indicated for major depression, panic disorder, obsessive-compulsive disorder (OCD) in both children and adults, and is the first and only treatment indicated for posttraumatic stress disorder (PTSD). (Zoloft received FDA approval for treatment of PTSD on December 8, 1999.)
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