Plan B One-Step – One-pill emergency contraceptive approved in US

Plan B One Step, a new one-pill emergency contraceptive, has been given approval in US.

Plan B One Step pill, which contains the synthetic version of estrogen levonorgestrel, can be taken as a single pill in one dose after unprotected sex or in the case of contraceptive failure to avoid unwanted pregnancy, said Teva Pharmaceutical Industries Ltd, the manufacturer of the pill said in a press release.

“Emergency contraception is more effective the sooner it’s taken, and with Plan B One-Step women can now act quickly and take it right away when the unexpected happens,” said Amy Niemann, General Manager, Senior Vice President of Teva Women’s Health.

Plan B One Step should be taken within 72 hours (3 days) of unprotected sex or contraceptive failure.

If taken correctly, about seven out of eight women who would have got pregnant will not become pregnant after taking Plan B One Step, the Israeli-based Teva claimed.

Plan B One-Step, however, cannot be used for inducing abortion. Plan B One Step will not work if a woman is already pregnant and it will not terminate an existing pregnancy.

Also, Plan B One-Step doesn’t protect against HIV and other sexually transmitted diseases (STDs).

Side effects of Plan B One Step include changes in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness.

Plan B One Step will be available at licensed U.S. retail pharmacies within the next month.

Plan B One-Step will be available over the counter for consumers aged 17 or older, and will be sold to women younger than age 17, as the US FDA is expanding over-the-counter (OTC) access to Plan B One-Step. However, women younger than age 17 will require a prescription but they will need a prescription to purchase the pill.

Emergency contraceptive pills are now available over-the-counter after U.S. District Court for the Eastern District of New York  asked in March to FDA to reconsider its decisions on the sale of the Plan B emergency contraceptive and ordered its producer to make the pills available to 17-year-olds without a prescription.

The court has also ordered US FDA to reconsider its decisions for Plan B over-the-counter sale. It was currently available only behind the counter then, so those who wanted to use the drug needed to ask a pharmacist for the pills.

Plan B was sold by Barr Pharmaceuticals, which was recently acquired by Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. Over 80 percent of Teva’s sales are in North America and Europe.

Plan B One-Step is manufactured in partnership with Teva Pharmaceutical Industries Ltd. by Gedeon Richter, Ltd. of Budapest, Hungary.