FDA approves 1-year vaginal ring contraceptive
The FDA has approved segesterone acetate and ethinyl estradiol vaginal system (Annovera) for the prevention of pregnancy for a 1-year period. Annovera is the first vaginal ring contraceptive that can be used for 1 full year. The reusable, nonbiodegradable, flexible vaginal system is placed in the vagina for 3 weeks, followed by 1 week out of the vagina, at which time women may experience a menstrual period (withdrawal bleed). This schedule is repeated for 1 year and provides contraception for 13 cycles. Annovera is a product of The Population Council, Inc.
Annovera's safety and efficacy were studied in three open-label clinical trials of healthy women ranging from 18 to 40 years of age. Based on the results of the studies, approximately 2 to 4 women out of 100 may become pregnant during the first year of use. Annovera was not adequately evaluated in females with a BMI greater than 29.
The most common adverse reactions in women in clinical trials included headache or migraine, nausea, vomiting, breast pain or discomfort, urinary tract infections, and yeast infections. The FDA is requiring postmarketing studies to further evaluate the vaginal ring. Similar to other hormonal contraceptives, Annovera carries a black box warning concerning the risk of serious cardiovascular events in women over age 35 who smoke and use combination hormonal contraceptive. Annovera has numerous contraindications and warnings; consult the product labeling for more information.
The vaginal ring is washed and stored in a compact case for the 7 days it is not in use and is cleaned again before reinsertion. It does not require refrigeration prior to dispensing and can withstand storage temperatures up to 86[degrees] F (30[degrees] C).
New drug approved to prevent malaria relapse
The FDA approved tafenoquine (Krintafel) for the radical cure to prevent the relapse of Plasmodium vivax malaria in patients age 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. It is the first new treatment for P. vivax malaria in more than 60 years and is the first single-dose medication for this type of relapsing malaria.
Tafenoquine is an 8-aminoquinoline derivative that is active against all stages of the P. vivax life cycle. It was tested in more than 4,000 study participants who received the 300 mg single dose and other doses of tafenoquine during clinical studies.
Tafenoquine is contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency or those with unknown status for the disorder, women who are breastfeeding an infant with a diagnosis of G6PD deficiency or an infant with unknown status for the disorder, and those with hypersensitivity to any of the components of the drug or to any drugs containing 8-aminoquinoline.
Tafenoquine is a product of GlaxoSmithKline and was developed in collaboration with Medicines for Malaria Venture, a nonprofit drug research partnership.
Sales of Essure birth control implants halted
Bayer will cease sales of its contraceptive implant, Essure, by the end of 2018. The company said the decision was based on a decline of the drug's US sales and the conclusion that the Essure business is no longer sustainable. The US is the last country in which Essure is marketed.
In 2016, the FDA put a black box warning on Essure's labeling and ordered safety studies be performed. The warning states that some patients with the Essure System for permanent birth control have experienced and/or reported adverse events, including persistent pain, hypersensitivity reactions, or perforation of the uterus and fallopian tubes that requires surgery to treat. Additionally, pregnancy, including ectopic pregnancy, has been reported among women who have had the Essure procedure.
Earlier this year, the FDA ordered that Essure only be sold through healthcare providers who guaranteed that women were being fully informed about the risks connected with the product. The FDA has released a statement saying that even when Essure is no longer sold, the agency will remain vigilant in protecting patients who already had the device implanted.