Zoloft is one of a class of drugs called SSRIs which are prescribed to treat many mood and anxiety disorders. The FDA approved Zoloft for use in adults, but its approval for use in children only extended to treatment of obsessive-compulsive disorder.
By as early as 1990, a link between increased suicidality and the use of SSRIs, including Zoloft, had been established by an article published in the American Journal of Psychiatry. Several other studies over the years further confirmed this risk. Pfizer, the manufacturer of Zoloft, sent a letter to the FDA in 1996, however, stating that these claims were overstated particularly with respect to suicidality in children. Close examination of Pfizer’s data, however, proved that their conclusions were faulty and that the data presented showed that children using Zoloft were four times more likely to commit suicide than children who did not use Zoloft.
Finally, in March of 2004, the FDA asked Pfizer and the manufacturers of other SSRIs to include a warning stating that both adult and child patients should be monitored for suicidal feelings, gestures, and attempts. The FDA stated that the suicides it had looked at may have been a result of the drug therapy rather than the underlying mental disorder. Pfizer has complied with the FDA’s requests, although it did oppose a black box warning stating that patients on Zoloft should be monitored closely for suicidality. Pfizer’s reasoning was that it felt the warning would increase the likelihood that adults and children would not seek treatment rather than increasing the likelihood that adults and children on Zoloft would be monitored appropriately. |
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