1. Health

The FDA's Advice to Women taking Estrogens and Progestins

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Updated December 19, 2003

9. Are there any risks that were found to be lowered in women taking estrogen plus progestin?

The WHI study results show that of every 10,000 women per year taking Prempro, there would be:
  • 6 fewer cases of colon cancer

  • 5 fewer cases of hip fracture

10. What are the major changes in the physician prescribing information and patient information leaflet for Premarin and Prempro?

The FDA is highlighting the important safety information from WHI and clarifying the treatment indications for Premarin and Prempro and asking all estrogen and progestin manufacturers to provide similar information for their products. Each woman's individual medical situation needs to be carefully discussed with her health care provider to make the best decision for her.

11. What is the FDA's advice to women?

  • Estrogens and progestins should not be used to prevent heart disease, heart attacks, or strokes.

  • Estrogens provide valuable therapy for many women, but carry serious risks, and therefore postmenopausal women who use or are considering using estrogen or estrogen with progestin treatments should discuss with their physicians whether the benefits outweigh the risks.

  • For hot flashes and significant symptoms of vulvar and vaginal atrophy, these products are the most effective approved therapies. These products are also options for women whose significant risk of osteoporosis outweighs the risks of treatment; other treatments for prevention of postmenopausal osteoporosis are available.

  • Estrogens and progestins should be used at the lowest doses for the shortest duration to reach treatment goals, although it is not known at what dose there may be less risk of serious side effects. Women should talk to their health care provider regularly about whether treatment is still needed.

12. Is it possible that FDA would think about taking Premarin and Prempro off the market?

The FDA is not thinking of taking Premarin and Prempro off the market at this time.

The FDA evaluates the ongoing safety and effectiveness of drugs both before and after their approval. The FDA monitors the safety of drugs through postmarketing surveillance and risk assessment programs to identify adverse events that appear during drug marketing. If changes are warranted, this information is used to update the physician prescribing information, to develop educational programs, and, on rare occasions, to reevaluate the original marketing approval decision.

Currently, the FDA and Wyeth seek to minimize risks and maximize benefits of Prempro and Premarin by ensuring that women and health care providers fully understand these risks and benefits.

13. Who should not take estrogens and progestins?

Women should not take estrogens and progestins if they:

  • think they are pregnant

  • have unusual vaginal bleeding

  • have had certain cancers

  • have had a stroke or heart attack in the past year

  • had blood clots

14. Are Premarin and Prempro safer in lower doses?

The dose of Prempro used in the WHI study was 0.625 mg, which is the same as 0.625 mg Premarin (conjugated estrogens) plus 2.5 mg medroxyprogesterone acetate (progestin). It is not known whether Premarin and Prempro are safer in lower doses. Generally, medicines should be used at the lowest effective dose. The FDA cannot make further recommendations until studies are performed using lower doses.

15. Are other estrogen and progestin drug products safer than Premarin or Prempro?

All estrogen and progestin drug products work in similar ways. Until there are data that show otherwise, postmenopausal women who take any type of estrogen or progestin should be similarly warned about risks.

16. How long should women take Premarin or Prempro

? Women taking estrogen and estrogens with progestins should discuss regularly with their health care provider how they are doing with the treatment and if they need to continue. Estrogens and progestins should be taken for the shortest duration possible to achieve treatment goals.

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