Seasonale

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Seasonale® is a brand of an extended-cycle combination birth control pill. It reduces the frequency of menstrual periods from 13 per year to four per year by changing the regimen of active pills from 21 to 84.

Seasonale contains 30 micrograms of ethinylestradiol and 150 micrograms of levonorgestrel in each active pill. Each package has 84 active pills and seven placebo pills that are taken at the end of the cycle. Menstrual occurs when the placebo pills are used every 3 months. Breakthrough bleeding, however, may occur and tends to decrease over time.^[1]

The medication is produced by Duramed Pharmaceuticals, a subsidiary of Barr Laboratories.

Seasonale was first developed by Barr Pharmaceuticals, alongside Eastern Virginia Medical School, under an agreement. [2] The Food and Drug Administration (FDA) then approved Seasonale on September 5, 2003.[3] Barr Pharmaceuticals, its manufacturer, claimed at its approval it would cost one dollar per pill.[2] Barr Pharmaceuticals currently markets about 75 pharmaceutical drugs, oral contraceptives being one of their key products. Seasonale is one of Barr Pharmaceuticals 22 oral contraceptive products. [4]

As noted by the Barr Pharmaceuticals, about 82% of all women living in the United States at some point in their reproductive lives have taken oral contraceptives. [4] This statistic shows that Seasonale is marketed to a large audience. Barr Pharmaceuticals targets this large audience by using the campaign, “Fewer periods. More possibilities.” [5] In late December of 2004, Barr Pharmaceuticals was warned by the FDA concerning their recent television advertisements. As the warning stated, “By omitting and minimizing the risks associated with Seasonale, the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience.” [6] Although the clinical studies had proven Seasonale to be effective in preventing pregnancy, the FDA felt the commercial advertisements omitted the common side effects of irregular vaginal bleeding or spotting.

Seasonique is another version of the extended-cycle pill that replaces the placebo week with a low-dosage week of estrogen. Quasense is a generic formulation, marketed by Watson Pharmaceuticals

[edit] References

^ Anderson FD, Gibbons W, Portman D. Long-term safety of an extended-cycle oral contraceptive (Seasonale): A 2-year multicenter open-label extension trial. Obstet Gynecol 2006;195:92-6

2. "Seasonale Extended Cycle OC Approved." About.com. Feb 2003. About.com. 22 Oct

2003. < http://headaches.about.com/cs/women/a/seasonale.html>.

3. United States. U.S. Food and Drug Administration. FDA Approves Seasonale Oral

Contraceptive: 2003. Sept. 2003. 22 Oct. 2006

<http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01251.html >.

4. Barr Pharmaceuticals. “Barr Pharmaceuticals, Inc.” Barr Pharmaceuticals, Inc. 2006.

Barr Pharmaceuticals, Inc. 22 Oct. 2006 < http://www.barrlabs.com/>.

5. Duramed Pharmaceuticals. "Seasonale: Birth Control That’s Just a Little Different."

Seasonale. 2006. Duramed Pharmaceuticals, Inc. 22 Oct. 2006

<http://www.seasonale.com>.

6. United States. Department of Health & Human Services. NDA #21-544

Seasonale® (levonorgestrel/ethinyl estradiol) Tablets MACMIS ID #12748: 2004.