At a meeting of FDA's Psychopharmacologic Drug Advisory Committee, Prozac was cited as an example of a drug whose adverse effects are underreported on the label. After initially reporting levels of sexual dysfunction at under 1%, Eli Lilly, maker of Prozac, now acknowledges it is 30%. One panel member, however, said most physicians find it to be 90%.
Sexual dysfunction
Incidences of sexual dysfunction by those taking Prozac, Zoloft, Paxil, and Luvox (all selective serotonin reuptake inhibitors) may be much higher than indicated on product labeling, and FDA is considering ordering labeling changes more reflective of reality.
Jan 31, 1998
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