FDA Approves Low-Estrogen Combination Oral Contraceptive

Yael Waknine

October 25, 2010

October 25, 2010 — The US Food and Drug Administration (FDA) has approved a prepackaged regimen of norethindrone acetate/ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets (LO Loestrin FE; Warner Chilcott) for the prevention of pregnancy.

The product features the lowest dose of estrogen (10 μg) currently available for contraceptive use in the United States and is expected to be available by prescription in early 2011.

Previously approved formulations of the company's iron-containing combination oral contraceptive contain 20 and 30 μg ethinyl estradiol, respectively (Loestrin FE 1/20 and Loestrin FE 1.5/30).

"We are excited about the approval of LO Loestrin FE, which complements our women's healthcare franchise and expands the product offerings in our branded oral contraceptive portfolio," said Roger Boissonneault, Warner Chilcott president and chief executive officer, in a company news release.

As with other combination oral contraceptives, the product's safety label includes a boxed warning regarding the increased risk for serious cardiovascular events in smokers — a risk that increases with age and the number of cigarettes smoked.

Adverse events associated with use of the contraceptive regimen include nausea and vomiting (7%), headache (7%), bleeding irregularities (5%), dysmenorrhea (4%), weight change (4%, breast tenderness (4%), acne (3%), abdominal pain (3%), anxiety (2%), and depression (2%).


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