The United States Food and Drug Administration (FDA) approved AnnoVera (Segeseterone Acetate and Ethinyl Estradiol) on August 10.
Annovera is a new type of viginal Ring contraceptive designed to prevent pregnancy.
It is a combined hormonal contraception for women in reproductive age for the prevention of pregnancy and the first Vaginal Ring Contraceptive, i-e, that can be used for a full year.
AnnoVera is a non-biodegradable reusable ring-shaped, elastic Vaginal System established for three weeks in the vagina, followed by a week out of the vagina where women can make (loss of bleeding) period. This program is repeated every four weeks for one year.
“The FDA is committed to supporting innovation in women’s health and today’s approval builds on available birth control options,” states Victor Crentsil, M.D., acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.
It is washed and stored in a compact house for seven days. Annovera does not need to cool before dispensing and can withstand storage temperatures up to 30 ° C.
The efficacy and safety of this ring were evaluated in three open clinical trials in healthy women between 18 and 40 years of age. According to the results, between two and four women out of every 100 women may become pregnant during the first year they take Annovera.
Each hormonal contraception causes serious dangers. Annovera carries a boxing warning about smoking and serious cardiovascular events. Women over 35 years of age should not use Annovera. Smoking cigarettes increase the risk of serious cardiovascular events through combined hormonal contraceptives.
Annovera Side Effects
The most common side effects in women who use this ring, like other combined hormonal contraceptives, include
- Headaches / migraines,
- Nausea / vomiting,
- Fungal infections,
- Abdominal pain,
- Dysmenorrhea (painful menstruation),
- Sore breasts,
- Bleeding irregular,
- Diarrhea and
- Itching in the genitals .
How It Work?
To use this, women place the ring in the vagina for three weeks and remove it for a week (what is known as withdrawal bleeding).
Annovera is contraindicated and should not be used in women with the following side effects:
- Hypersensitivity to some of the components in Annovera;
- High risk of arterial or venous thrombotic diseases;
- Liver tumors, acute hepatitis or severe cirrhosis (decompensated);
- Current or past history of breast cancer or other forms of estrogen or progestin-sensitive cancers;
- Undiagnosed abnormal uterine bleeding;
- Use of combinations of hepatitis C drugs containing Ombitasvir / Paritaprevir / Ritonavir with or without dasabuvir.
The FDA requires post-marketing studies to assess the risk of venous thromboembolism and the effects of drugs and tampons on the pharmacokinetics of AnnoVera in modulating CYP3A.
The FDA granted approval of this to The Population Council, Inc.
Source: United States Food & Drug Administration (FDA)