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Ovcon, a hormonal birth control pill, contains high doses of estrogen and progestin that have been linked to an increased risk of breast cancer.

What is Ovcon?

Ovcon is a hormonal birth control pill that contains a combination of progestin (norethindrone) and estrogen (ethinyl estradiol). It comes in two doses, both of which have been discontinued as of 2012.

Active ingredients in Ovcon include:

  • Ovcon-50: 50-micrograms of estrogen (ethinyl estradiol) and 1-milligram of progestin (norethindrone).
  • Ovcon-35: 35-micrograms of estrogen (ethinyl estradiol) and 0.4-milligrams of progestin (norethindrone).

FDA Warning Letter for Quality Control Issues

March 8, 2012 — The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Warner Chilcott, a Puerto Rican drug-maker that acquired Ovcon in 2005.

The FDA was concerned that the company should have known that certain lots were subpotent due to changes in the drying process dating back to 2006. However, Ovcon was not recalled until June 21, 2011, when tests indicated that it did not have the correct amount of estrogen.

Ovcon and Breast Cancer

Birth control pills have been linked to breast cancer in several studies. Estrogen and progestin have been found to influence the development and growth of some cancers. These hormones are known to stimulate breast growth and the proliferation of cells in the breast, which may increase the risk of malignant mutations.

Study Links High-Dose Estrogen and Tripled Risk of Breast Cancer

In August 2014, Cancer Research published a study linking the use of hormonal birth control pills with a 50% increased risk of breast cancer.

Women on doses of estrogen higher than 50-micrograms, such as Ovcon-50, had a 2.7-fold increased risk of breast cancer.

Women on triphasic dosing with an average of 0.75-mg of norethindrone (Ovcon-50 and Ovcon-35 contain 1-mg and 0.4-mg, respectively) were 3.1-times more likely to be diagnosed with breast cancer.

Symptoms of Breast Cancer

  • Lump in the breast or armpit that is hard and usually painless
  • Breast changes size, shape, or texture
  • Skin texture may be reddish and dimpled like an orange
  • Nipple discharge (clear, bloody, etc.)
  • Swelling in the armpit or breast
  • Breast pain or discomfort
  • And more