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New Vaginal Ring Approved for An Entire Year of Birth Control

Venous Thromboembolism and Other Risks to Be Evaluated in Postmarketing Studies

The FDA has approved Annovera (segesterone acetate and ethinyl estradiol vaginal system, The Population Council), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy; it is the first vaginal ring contraceptive that can be used for an entire year. Annovera is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).

Annovera is washed and stored in a compact case for the seven days when it is not in use. Annovera does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30°C (86°F).

The efficacy and safety of Annovera were studied in three, open-label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about two to four women out of 100 women may get pregnant during the first year they use Annovera.

Annovera carries a boxed warning relating to cigarette smoking and serious cardiovascular events. Women over 35 who smoke should not use Annovera.

Annovera is contraindicated in women with:

  • A high risk of arterial or venous thrombotic diseases;
  • Current or history of breast cancer or other estrogen- or progestin-sensitive cancer;
  • Liver tumors, acute hepatitis, or decompensated cirrhosis;
  • Undiagnosed abnormal uterine bleeding;
  • Hypersensitivity to any of the components of Annovera; and
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

The most common side effects in women using Annovera are similar to those of other combined hormonal contraceptive products and include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, diarrhea and genital itching.

The FDA is requiring postmarketing studies to further evaluate the risks of venous thromboembolism, and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera.

Source: FDA.gov, August 10, 2018

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