Prozac is Approved by the FDA
Fluoxetine hydrochloride had been approved for use in Belgium the year before.
But the imprimatur of the U.S. Food and Drug Administration heralded a whole new era. At first, just scientists were excited, because Prozac, as the Eli Lilly company christened it for the market, was the first in a new class of medications that would treat depression by exquisitely controlling the levels of serotonin, a brain chemical involved in mood. But the FDA's approval letter became the founding charter for a Prozac nation, as vast numbers of American consumers were seduced by a prescription to lift one's mood. Today they spend more than $1 billion on Prozac each year, to treat not just depression but also obsessive-compulsive disorder and premenstrual syndrome. The cultural revolution has escalated with the arrival of new antidepressants without Prozac's occasional side effects—nightmares, violence, loss of libido. And in the tradition of imitation as the ultimate form of flattery, by 2001 cheaper generic fluoxetine hit the market.
INDIANAPOLIS, IN -- May 18, 1999 -- A scored tablet version of Eli Lilly and Co.’s antidepressant Prozac(R) (fluoxetine hydrochloride), which is expected to provide greater dosing convenience for physicians and patients, will be available at pharmacies in the United States starting June 1, 1999.
The scored tablet was approved March 10, 1999 by the U.S. Food and Drug Administration. The tablet includes the same active ingredients as the capsule version of Prozac.
The 10 milligram oval green tablet is the first tablet version of Prozac to be developed since the antidepressant became available more than 11 years ago. Prozac, approved by the FDA for the treatment of depression on Dec. 29, 1987, also is indicated for the treatment obsessive compulsive disorder and bulimia and is available in 20 milligram capsules, 10 milligram capsules and a liquid formulation.
Because the new tablet version of Prozac can be split in half, it will provide greater dosing convenience for physicians. Therapy for most depressed patients using Prozac includes one 20 milligram capsule daily. Some patients -- particularly older patients -- occasionally are prescribed dosages of less than 20 milligrams. The new tablet version will provide physicians with the ability to customise dosages to the needs of their patients. Dosages should not exceed 80 milligrams per day.
The tablet version of Prozac will not be available outside the U.S.
Prozac was the first selective serotonin reuptake inhibitor antidepressant to be introduced in the U.S. It currently is available in more than 100 countries for treatment of depression and has been used by more than 35 million people globally since first becoming available in 1987.
The most commonly observed adverse events associated with the use of Prozac versus placebo in U.S.-controlled clinical trials for depression, OCD and bulimia combined were: nausea (23 versus 10 percent), headache (21 versus 20 percent), insomnia (20 versus 11 percent), anxiety (13 versus eight percent), nervousness (13 versus nine percent) and somnolence (13 versus six percent).
Prozac is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor and an MAO inhibitor is contraindicated for at least five weeks after discontinuation with Prozac. Prozac should be discontinued immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be identified.
Safety and effectiveness in pediatric patients have not been established.
Evaluation of patients over the age of 60 who received Prozac 20 milligrams daily revealed no unusual pattern of adverse events relative to the clinical experience in younger patients. However, these data are insufficient to rule out possible age-related differences during chronic use, particularly with elderly patients with concomitant systemic illnesses or who are receiving concomitant drugs. A lower or less frequent dosage should be considered for the elderly.