New Directions for “The Pill”

Contributed by: Tammy Stack, Pharm.D.

Community Pharmacy Resident

Text Box: The year 1960 was a breakthrough year for American women. For decades, contraception had been considered illicit, obscene and illegal in many states. In May of 1960, the FDA approved "The Pill", the first oral contraceptive for women. This pill, called Enovid®, contained a combination of estrogen and progesterone. When taken orally, the hormones prevented ovulation, and thus pregnancy, in women of childbearing age. In most cases, an active pill was taken for 21 days, then an inactive or placebo was taken for 7 days to allow menstruation, and the cycle was begun again. Since the introduction of Enovid®, a number of estrogen/progestin combinations have been developed as oral contraceptives or birth control. "The Pill" is available as over 30 products in the United States. These combinations exist as monophasic (i.e. Alesse®, Ovcon®, Lo/Ovral®, etc.),in which all the active pills contain the same amount of hormones. Biphasic products (i.e. Necon 10/11) contain a series of pills in which the ratio of estrogen to progestin changes at some point during the cycle. Triphasic products (i.e. Estrostep®, Ortho-TriCyclen®, Tri-Levlen®, etc.) contain three different hormone ratios thought to more closely mimic the body's own cycle. With each of these, a woman either takes an active pill for 21 days and then either a week of placebo tablets or no tablets to allow the body to go through menses, with the cycle beginning again at 28 days. Recently, new products have been approved by the FDA to expand a woman's options for birth control. Seasonale® is a combination of levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). An "active" pill is intended to be taken for 84 days and an inactive pill for 7 days. While taking the inactive pills, a woman resumes her period only 4 times a year instead of 13. Many women are

Text Box: attracted to the idea of having a period every three months instead of every month. The efficacy and safety of Seasonale® is comparable to that of the other oral contraceptives. Common side effects include headache, nausea, painful menstruation, and breast tenderness. Serious risks include blood clots, stroke, or heart attack. These risks are higher in smokers and especially in women over 35 years old. For more information about Seasonale®, see www.seasonale.com/. For women who wish to avoid remembering to take a pill every day, there are other hormonal options for birth control. The Ortho-Evra® transdermal patch and the Nuvaring® are also available. Both of these contain combinations of estrogen/progestins to prevent ovulation and pregnancy. Ortho-Evra® is a patch much like a band aid that contains the hormones norelgestromin (a progestin) and ethinyl estradiol (an estrogen). The patch is applied to clean dry healthy skin on the buttock, abdomen, upper outer arm, or upper torso (but not on the breasts) once a week for 3 weeks. The patch remains on the skin for the entire week. The patch should be placed on a different site each week. The fourth week is patchless. During the three weeks the patch is worn, the hormones are absorbed through the skin, and into the blood stream and the entire body. A woman has her period then during the fourth week. After 7 days a new patch is placed on the body for the next cycle. Side effects are similar to those of oral contraceptives or Seasonale. Some patients may be sensitive to the adhesive holding the patch in place. For more information about the Ortho-Evra patch, see www.fda.gov/cder/consumerinfo/druginfo/orthoevra.htm or www.orthoevra.com. Another hormonal contraceptive option for women is the Nuvaring®. Nuvaring®

Text Box: is a soft flexible ring about 2 inches in diameter that is embedded with etonogestrel (a progestin) and ethinyl estradiol (an estrogen), a hormonal combination similar to those found in many oral contraceptives. The ring is inserted into the vagina for 21 days. Muscles within the vagina hold the ring in place. Contact with the vaginal walls cause the hormones to be released from the ring, become absorbed by the skin of the vaginal walls, and enter the blood stream. After 21 days, the ring is removed to allow menstruation, and after 7 days a new one is replaced, and the cycle begins again. With this product, side effects are also similar to those experienced with oral contraceptives. Based on a survey of thousands of Nuvaring® users, a sexual partner could not feel the presence of Nuvaring® in 8 out of 10 patients. Those who could feel the ring reported not minding it. For more information about Nuvaring®, visit www.nuvaring.com. It is important to remember that these products do carry risk of blood clots, stroke, or heart attack. These risks are especially high in women who smoke cigarettes. Women over 35 who smoke should not use these contraceptives. If you are interested in one of these products for birth control, speak to your physician or pharmacist, and visit the web sites mentioned above. For an interesting look at the history of birth control, see www.pbs.org/wgbh/amex/pill/.