FDA Approves Prozac as an Antidepressant Summary

  • Last updated on November 10, 2022

With U.S. Food and Drug Administration approval, Prozac was introduced in the United States as a new way to manage depression. Thanks to brilliant marketing and the promise of few side effects, Prozac revolutionized psychiatry’s approach to depression and paved the way for a flurry of similar drugs.

Summary of Event

The concept of depression has been around for thousands of years. Hippocrates, the fifth century b.c.e. Greek physician known as the father of medicine, used the word “melancholia” to describe what was termed in the eighteenth century as “depression.” However, it was not until the twentieth century that depression was viewed as a distinct mental disorder, as opposed to an anxiety disorder. Depression, clinical Clinical depression Sigmund Freud helped to popularize the idea of “nerves” as something that could be treated by drugs or talking therapies. Until the 1950’s, the most common drugs used to treat depression were bromides, barbiturates, stimulants, and sedatives. Prozac Antidepressants Fluoxetine hydrochloride Eli Lilly and Company Psychiatry;antidepressants Selective serotonin reuptake inhibitors [kw]FDA Approves Prozac as an Antidepressant (Dec. 29, 1987) [kw]Prozac as an Antidepressant, FDA Approves (Dec. 29, 1987) [kw]Antidepressant, FDA Approves Prozac as an (Dec. 29, 1987) Prozac Antidepressants Fluoxetine hydrochloride Eli Lilly and Company Psychiatry;antidepressants Selective serotonin reuptake inhibitors [g]North America;Dec. 29, 1987: FDA Approves Prozac as an Antidepressant[06650] [g]United States;Dec. 29, 1987: FDA Approves Prozac as an Antidepressant[06650] [c]Health and medicine;Dec. 29, 1987: FDA Approves Prozac as an Antidepressant[06650] [c]Psychology and psychiatry;Dec. 29, 1987: FDA Approves Prozac as an Antidepressant[06650] Wong, David T. Fuller, Ray W. Malloy, Bryan B. Schmiegel, Klaus K. Kramer, Peter D.

In 1955, the drug Miltown Miltown (meprobamate) was launched and was marketed as a “tranquilizer,” not as a new sedative. Tranquilizers It was the first drug developed for the anxiety of ordinary life, not for the severely depressed. Miltown was followed by Librium Librium and Valium Valium in the early 1960’s. In the 1970’s, soaring sales made Valium the best-selling drug on the market. However, in the 1980’s, amid a media frenzy declaring the possibility of dependence on tranquilizers, sales plummeted, effectively ending the tranquilizer era and opening the market to a new group of drugs known as antidepressants.

Antidepressants were first discovered in 1957 when Nathan S. Kline Kline, Nathan S. found the tuberculosis drug iproniazid, a sedative, to be effective in treating depressed patients. A few months later, Roland Kuhn Kuhn, Roland noticed that the tricyclic antidepressant imipramine, a sedative, also lifted the mood of depressed patients. These drugs launched two basic varieties of antidepressants, monoamine oxidase inhibitors Monoamine oxidase inhibitors (MAOIs) and tricyclics. Tricyclics Both types of drugs bolstered the action of various neurotransmitters in the brain, including serotonin and norepinephrine. While these drugs alleviated many symptoms related to depression, they had several unpleasant side effects. The MAOIs could be deadly if taken with dairy products, red wine, beer, or allergy medicine. The tricyclics could cause low blood pressure and heart disturbances. Because of their side effects, sales of these drugs lagged far behind sales of tranquilizers.

In 1972, scientists David T. Wong, Ray W. Fuller, Bryan B. Malloy, and Klaus K. Schmiegel at Eli Lilly and Company developed the selective serotonin reuptake inhibitor (SSRI) fluoxetine hydrochloride. By finding a compound that prevented the reuptake of serotonin alone, these researchers were able to find an antidepressant as effective as other tricyclics but with fewer side effects. In a landmark marketing move, Lilly hired an outside company to create a name for this product. Prior to the naming of Prozac, drugs were named to reflect their actual chemical composition. This decision changed the way drugs were named.

Getting the drug approved for the U.S. market was the next challenge. At that time, federal support of psychopharmacology research had dwindled and industry-run clinical trials were used to test new products. At the same time, the Food and Drug Administration Food and Drug Administration (FDA) regulations changed, stating that new compounds must be tested against a placebo to prove their effectiveness. Prozac underwent three placebo-controlled studies, with two in favor of its effect. Lilly set a target date of 1986 to introduce the new antidepressant in the United States. After four years of scrutiny, the FDA finally approved the new drug on December 29, 1987. As a result of the new FDA regulations, Prozac became the first antidepressant to hit the market in a long time.

By the time Prozac arrived in the United States and Canada in 1988, the drug had already been approved for use in Belgium and South Africa. By the end of 1989, the drug was allowed in most countries and was the world’s most widely prescribed antidepressant. Led by a vigorous marketing campaign, patients came to their physicians asking for Prozac by name, an experience previously unheard of by American psychiatrists. Television talk shows, magazine cover stories, and newspaper articles sang the praises of this new wonder drug.

It did not take long for criticism to surface in opposition to Prozac’s growing use. The Citizens Commission on Human Rights Citizens Commission on Human Rights (CCHR) launched a campaign denouncing Prozac in 1989. The organization’s criticism was supported by the 1990 findings reported by Harvard psychiatrist Martin Teicher Teicher, Martin and two of his colleagues. They described six patients who, after several weeks on Prozac, developed obsessive suicidal desires for the first time. The article raised public apprehension about the drug, and the CCHR petitioned the FDA to withdraw its approval. Product-liability suits were filed against Lilly by survivors of suicide victims, and malpractice suits were filed against doctors who had prescribed the drug. Sales of Prozac dropped sharply, but the company defended the product aggressively. Lilly representatives attributed the violent or suicidal behavior to the underlying condition of depression. In their argument, Prozac had not caused the behavior, but rather failed to help those patients.

The FDA’s Psychopharmacological Drugs Advisory Committee listened to testimony from patients, medical personnel, and company researchers. In October, 1991, the committee issued its report, stating that it found no causal link between the use of antidepressant drugs, including Prozac, and violent or suicidal behavior. With the FDA’s renewed blessing, sales of Prozac regained momentum, and the drug became the most widely prescribed antidepressant in the world.

Sales of Prozac surged with the release of Peter D. Kramer’s best-selling book Listening to Prozac in 1993. Listening to Prozac (Kramer) In the book, Kramer described how many patients with relatively minor symptoms such as shyness, unhappiness, or social isolation became dramatically better after taking Prozac. These patients reported feeling better than they ever felt before. One patient remarked that he could be who he really was when taking Prozac. Kramer called this phenomenon “cosmetic psychopharmacology.” This “better than well” observation was also made by several other psychiatrists.

Kramer’s book put Prozac in the media forefront once again, setting off a groundswell of praise and controversy. The response from the bioethics community was to classify the “better than well” phenomenon as “enhancement technology.” The moral controversy focused on whether or not medical treatment should be funded if seen as an enhancement as opposed to a treatment. Was it the job of the medical community to make patients feel better than well? Were the demands of people in our society unreasonable? As the sale of Prozac continued to swell, the controversy continued.


The approval of Prozac by the FDA in 1987 marked the beginning of what has often been described as the antidepressant era. Soon after Prozac was put on the market, it was joined by similar SSRIs such as Paxil, Luvox, Zoloft, Effexor, and Celexa. These drugs were prescribed not only for depression but also for an array of other disorders such as social phobia, panic disorders, obsessive-compulsive disorder, eating disorders, Tourette’s syndrome, and sexual compulsions. Perhaps what stands out about Prozac more than anything else is the way it crossed over from the medical community and into the culture as a whole. The name Prozac became synonymous with “antidepressants.”

By the year 2000, Prozac had more than forty million users worldwide. This accounted for one fourth of Lilly’s $10.8 billion sales and more than one third of its $3 billion annual profits. On August 4, 2001, Prozac’s patent expired, and generic versions of the drug entered the market. While profits for Lilly dipped, new antidepressants were introduced. By 2007, antidepressants were prescribed more than any other drug for any chronic condition other than high blood pressure.

Prozac brought depression and mental illness out of the closet and into the forefront. Thanks to this drug and others like it, depression was no longer seen as a failure of character, but rather as a treatable mental disorder. Controversies remain, but many people agree that the drug has offered relief from the grip of mental illness for millions of people around the world. Prozac Antidepressants Fluoxetine hydrochloride Eli Lilly and Company Psychiatry;antidepressants Selective serotonin reuptake inhibitors

Further Reading
  • citation-type="booksimple"

    xlink:type="simple">Elliott, Carl, and Tod Chambers, eds. Prozac as a Way of Life. Chapel Hill: University of North Carolina Press, 2004. Collection of eleven essays discusses the ethical and cultural dimensions of the popularity of SSRI antidepressants. Includes bibliographic notes.
  • citation-type="booksimple"

    xlink:type="simple">Glenmullen, Joseph. Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives. New York: Simon & Schuster, 2000. Uses narratives to discuss the dangers of Prozac. Includes bibliographic notes.
  • citation-type="booksimple"

    xlink:type="simple">Healy, David. Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression. New York: New York University Press, 2004. Explores the history of SSRIs and the controversies surrounding them. Healy is considered the leading authority on the history of psychopharmacology. Includes bibliographic notes.
  • citation-type="booksimple"

    xlink:type="simple">Kramer, Peter D. Listening to Prozac. New York: Viking, 1993. In this best seller, Kramer coined the term“cosmetic psychopharmacology,” introducing the idea that Prozac made people feel “better than well.” This book made Kramer one of the most well-known psychiatrists in the United States. Includes bibliographic notes.
  • citation-type="booksimple"

    xlink:type="simple">Norden, Michael J. Beyond Prozac: Brain-Toxic Lifestyles, Natural Antidotes, and New Generation Antidepressants. New York: ReganBooks, 1995. Argues that the stresses of modern life have made us all “Prozac deficient.” Discusses ways to boost the human serotonin system. Includes bibliography.

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Categories: History