History of Zoloft and Prozac
43 •
Prozac was introduced in 1988, about thirty years after the first
antidepressants became available. Because of its specific effect on
serotonin, Prozac offered relatively few side effects. Previous prob-
lems with the heart were not likely with Prozac, and patients did not
feel lethargic or sedated.
Zoloft (sertraline hydrochloride) and the other SSRIs were devel-
oped after Prozac. Although these drugs do have side effects, these
are less severe than those of the antidepressants that were devel-
oped before them. For those suffering from depression, the drugs
are able to change serotonin levels and affect the brain positively.
Drug Approval
Before a drug can be marketed in the United States, it must be of-
ficially approved by the Food and Drug Administration (FDA).
Today’s FDA is the primary consumer protection agency in the
United States. Operating under the authority given it by the gov-
ernment, and guided by laws established throughout the twen-
tieth century, the FDA has established a rigorous drug approval
process that verifies the safety, effectiveness, and accuracy of la-
beling for any drug marketed in the United States.
While the United States has the FDA for the approval and
regulation of drugs and medical devices, Canada has a similar or-
ganization called the Therapeutic Product Directorate (TPD).
The TPD is a division of Health Canada, the Canadian govern-
ment department of health. The TPD regulates drugs, medical
devices, disinfectants, and santizers with disinfectant claims.
Some of the things that the TPD monitors are quality, effective-
ness, and safety. Just as the FDA must approve new drugs in
the United States, the TPD must approve new drugs in Canada
before those drugs can enter the market.




