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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.