Panel Recommends Zoloft for Stress
WASHINGTON (AP) _ The widely used antidepressant Zoloft also should be approved for treating posttraumatic stress syndrome, a federal advisory panel said Friday.
But panelists cautioned the drug so far seems to help only women, not men, with the anxiety disorder, which can result after a life-threatening or otherwise traumatic experience such as combat, rape, assault or a natural disaster.
Symptoms of posttraumatic stress include flashbacks, nightmares, persistently avoiding reminders of the event, survivor guilt, insomnia and depression.
Many psychiatrists have long prescribed antidepressants along with psychological therapy to treat posttraumatic stress. But if the Food and Drug Administration specifically approves Zoloft’s use, manufacturer Pfizer Inc. will be allowed to advertise the drug for such treatment, potentially widening sales.
Zoloft already treats depression, obsessive-compulsive disorder and panic disorder.
Pfizer conducted four clinical trials of Zoloft to treat posttraumatic stress. In two of the studies, Zoloft failed to work any better than the placebo, while it alleviated symptoms better than the placebo in another two studies.
Consequently, FDA’s scientific advisory panel voted 6-2, with one abstention, that Zoloft’s new use should be approved. The FDA is not bound by its advisers’ recommendations but typically follows them.
However, the drug’s effectiveness was almost exclusively found in women, the FDA said. One study in which Zoloft failed, in fact, was a study of male combat veterans. The FDA’s advisers said this gender effect must be noted on Zoloft’s label if the drug is sold for posttraumatic stress.