FDA Approves Prozac as First Drug for Severe Premenstrual Syndrome

Strategic Insights -

Federal regulators have approved Prozac, a medication used to control mood swings and discomfort in severe premenstrual syndrome (PMS). The U.S. Food & Drug Administration (FDA) has approved a new brand name, Sarafem, for the drug, which will be available in pharmacies in August. This approval marks the first prescription drug treatment for severe PMS, also known as Premenstrual Dysphoric Disorder (PMDD), in which symptoms interfere with personal relationships and work.

Key Takeaways:

  • The FDA has approved Prozac, a medication known as fluoxetine hydrochloride, as the first prescription drug treatment for severe PMS.
  • The drug will be marketed under the brand name Sarafem and will be available in pharmacies in August.
  • The U.S. FDA estimates that severe PMS affects about 3 to 5 percent of women of reproductive age.
  • Eli Lilly & Co., the manufacturer of Prozac and Sarafem, has stated that the two are the same drug, with the name change aimed at helping women distinguish between depression and PMDD.
  • A spokeswoman for Eli Lilly notes that the company is exploring alternative dosing schedules for women, but for now, they will have to take Sarafem daily throughout the menstrual cycle.
  • Prozac has been used by 38 million people worldwide since its approval in late 1997 for depression and has also been cleared for treatment of obsessive compulsive disorder and bulimia.
  • Common side effects of the drug include nausea, fatigue, nervousness, dizziness, and difficulty concentrating.
  • An expert panel that advises the FDA unanimously recommended approving fluoxetine for treatment of PMDD in November 1999, with the condition that the drug only be given to women who have symptoms severe enough to interfere with day-to-day living.

Statistics:

  • 3-5% of women of reproductive age suffer from severe PMS (PMDD)
  • 38 million people worldwide have used Prozac since its approval in late 1997 for depression
  • The FDA has approved Prozac/Sarafem for the treatment of PMDD
  • 11/16/1999: Expert panel recommends approving fluoxetine for PMDD treatment
  • 2,000,000: estimated number of women affected by severe PMS in the United States

Sources:

  • U.S. Food & Drug Administration
  • Eli Lilly & Co.
  • Dr. Gary Tollefson, president of neuroscience products at Eli Lilly
  • Dr. Peter Schmidt, researcher at the National Institute of Mental Health