The FDA has approved the morning after pill for women of any age as an over-the-counter medication and with no point-of-sale restrictions. Over-the-counter (OTC) means that no prescription is required.
The FDA said the approval is for “women of child bearing age potential”, i.e. any female who can get pregnant.
The approval of Plan B One-Step (levonorgestrel) as an OTC medication for all women of all ages complies with the April 5th, 2013 order by the US District Court of New York.
WHAT IS PLAN B ONE-STEP?
Plan B One-Step (levonorgestrel), also known as the morning after pill is an emergency contraceptive a female takes to reduce her chances of pregnancy after either unprotected sexual intercourse or suspected contraceptive failure. An example of a (suspected) contractive failure could be a condom that leaked.
Experts say that the term “morning-after pill” is a misnomer, because the pill is most effective when used shortly after sex.
Plan B One-Step is now available OTC for all women of childbearing age potential
According to Teva Women’s Health, the makers of Plan B One-Step, the drug can be used within 72 hours after sex, but ads that the sooner it is taken, the more effective it is.
Plan B One-Step contains levonorgestrel, the same ingredient that is used in many birth control pills and works similarly by stopping ovulation (stops the release of an egg from the ovary). It has a higher level of levonorgestrel than other contraceptive pills that doctors have been prescribing for decades.
Teva Women’s health emphasizes that Plan B One-Step:
- Is not an abortion pill (an RU-486)
- Is ineffective if the woman is already pregnant
- Should not affect/terminate an existing pregnancy
- Is not intended as a regular form of birth control
- Will not protect the woman from HIV or other STDs (sexually transmitted diseases)
The FDA says that it notified a US District Court judge in New York that it intended to comply with the court’s order. The Agency asked Teva Women’s Health to submit a supplemental application for approval of Plan One-Step B to be made available OTC with no restrictions. The FDA says it has now fulfilled its commitment to the court.
Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said:
“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.”
In July 2009, Plan B One-Step was approved by the FDA as an OTC medication for females aged at least 17 years, and as a prescription-only product for younger patients.
The FDA later approved Plan B One-Step as an OTC product for females aged 15+ yearsearlier this year.
In an online communiqué yesterday, the FDA wrote “With this approval, the product is now available without a prescription for use by all women of reproductive potential.”
The FDA reminded young women who are sexually active and do not plan or intend to become pregnant to see a health care provider for routine checkups. The health care provider should advise them about, and test them for STDs, as well as discuss effective methods of birth control.
The following side effects are associated with Plan B One-Step usage:
- stomach ache
- breast tenderness