FDA approves “morning after pill” for over-the-counter sale


planb-175The US Food and Drug Administration (FDA) has approved the so-called “morning after pill” Plan B One-Step for over-the-counter sale.

That means the emergency contraceptive can be purchased by all women of “child-bearing potential” without a prescription, the FDA said..

Plan B One-Step can prevent  pregnancy following unprotected sexual intercourse or a known or suspected contraceptive failure, such as may occur with a condom, if taken as soon as possible within three days after unprotected sex.

Plan B One-Step was first approved in July 2009 for use without a prescription for women age 17 and older and as a prescription-only option for women younger than age 17.

The  drug contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to these contraceptive pills by stopping ovulation and therefore preventing pregnancy.

Plan B One-Step will not stop a pregnancy when a woman is already pregnant and there is no medical evidence that the product will harm a developing fetus, the FDA said.

The product, however, will not protect a woman from HIV/AIDS or other sexually transmitted diseases, and so it is important that young women who are sexually active see a healthcare provider for routine checkups, the FDA warned.

The health care provider should counsel the patient about, and test them for sexually transmitted diseases, discuss effective methods of routine birth control, and answer any other questions the patient may have, the FDA said.

Some women taking Plan B One-Step have reported experiencing the following side effects:  nausea, vomiting, stomach pain, headache, dizziness and breast tenderness. These are similar to the side effects of regular prescription-only birth control pills.