Ovcon, a birth control pill, was recalled in 2011 and taken off the market in 2012. Unfortunately, recent studies have found higher rates of breast cancer in women who used high doses of estrogen or progestin (especially enorethindrone). These risks returned to normal within one year of discontinuing high-dose birth control pills.
What is Ovcon?
Ovcon is an oral contraceptive that is used to prevent pregnancy. It contains a combination of estrogen and progestin, which reduce the chances of a sperm fertilizing an egg by thickening cervical mucous and thinning the lining of the uterus.
Ovcon active ingredients include:
- Ovcon-50: 50-mcg of ethinyl estradiol (estrogen) and 1-mg of norethindrone (progestin).
- Ovcon-35: 35-mcg of ethinyl estradiol (estrogen) and 0.4-mg of norethindrone (progestin).
FDA Warning Letter After Ovcon Recall
In March 2012, the U.S. Food and Drug Administration (FDA) inspected the Puerto Rican manufacturing facilities of Ovcon and issued a Warning Letter to the drug-maker, Warner Chilcott.
The inspection occurred shortly after Ovcon was recalled in June 2011. Inspectors found that Warner Chilcott changed the drying process when they acquired Ovcon in 2005, which resulted in pills that did not have consistent potency. Although the drug-maker should have known about problems with subpotent estrogen levels, they failed to implement corrective action for years.
Ovcon and Breast Cancer
The National Cancer Institute warns that several studies have linked the use of birth control pills with an increased risk of breast cancer. Estrogen is a powerful hormone that is known to stimulate the proliferation of epithelial cells in the breast, which increases the risk of malignant cell mutations.
Birth Control With High Estrogen May Triple Breast Cancer Risk
August 1, 2014 — Cancer Research has published a study linking the use of birth control pills with a 50% increased risk of breast cancer.
Women on Ovcon may have an even higher risk of breast cancer. Birth control pills with estrogen doses higher than 50-mcg (such as Ovcon-50) were associated with a 2.7-fold increased risk of breast cancer.
Women on triphasic-dosed pills with an average of 0.75-mg of norethindrone were 3.1-times more likely to be diagnosed with breast cancer. Ovcon-35 and Ovcon-50 contain 0.4-mg and 1-mg of norethindrone, respectively (average 0.7-mg).
Breast Cancer Signs & Symptoms
- Breast lump that is hard (may feel like a marble under the skin)
- Breast pain or tenderness (lump is usually painless)
- Changes in breast size, shape, color, or texture
- Changes in skin texture (may become reddish and pitted like an orange)
- Nipple discharge (may be white, clear, green, or resemble pus)
- Armpit swelling
- And more