6 Of The Most Important Milestones In The History Of Drugs (5of6)

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Prozac

Library of Congress

Prozac and its half-dozen “band of brothers”—selective serotonin reuptake inhibitors (SSRIs)—are the most commonly prescribed class of antidepressants, in spite of questions regarding their effectiveness. However, there is no question that SSRIs cause fewer side effects and are safer when taken in overdose than the tricyclics.
During the 1970s and 1980s, the link between serotonin and depression became more convincing. Interest focused on the SSRIs, drugs that preferentially increase serotonin at mood-influencing sites in the brain. Prozac (fluoxetine), first approved in 1987 and marketed the following year, was later joined by Celexa, Lexapro, Luvox, Paxil, and Zoloft, plus a generous number of generic equivalents.
The approved medical uses of the SSRI differ somewhat around the world but often include anxiety and panic disorders, obsessive-compulsive disorders (think Lady Macbeth), and clinical depression. When used to treat severe depression, they start producing their beneficial effects in two to four weeks, which is comparable to the tricyclics. To reduce the risk of relapse, a common concern, antidepressants are generally taken for at least six months—and, often, for years—after recovery. Some 20– 25 percent of individuals who abruptly stop taking these medications experience SSRI discontinuation (withdrawal) syndrome.
Notwithstanding their marketplace success, the use of SSRIs is embroiled in controversy. Some 30–40 percent of depressed patients receiving placebos improve, which complicates studies attempting to objectively demonstrate the effectiveness of SSRIs. Two critical meta-analyses of multiple studies appearing in 2008 and 2010 concluded that, when compared with placebos for the treatment of mild to moderate depression, SSRIs provided little or no benefit. SSRIs were, however, quite effective for treating severe depression. Regulatory agencies in the United States and United Kingdom have concluded that SSRIs can increase suicidal thoughts in children, adolescents, and young adults up to the age of twenty-four, although suicide attempts have not increased. This risk has not been shown for adults.
When Eli Lilly’s patent for Prozac expired in 2001, they rebranded Prozac as Sarafem—same drug, different color capsule—at a much higher price than generic fluoxetine for “premenstrual dysphoric disorder.”

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