Premenstrual Disorders

Drug Approval

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. 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. 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.

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History of Zoloft and Prozac