No More Prescription for Emergency Contraceptives


August 24, 2006 - Food and Drug Administration –

Plan B, an emergency contraceptive, known to millions of women as the Morning-After Pill, became available over-the-counter without a prescription after the appropriate approval from the American Food and Drug Administration, as the official press-release says.

The main goal of emergency contraception is to prevent pregnancy after the unprotected sexual intercourse or when other contraception methods (for example, condoms) failed. Such pills should be taken as soon as possible after sex, but till recently a woman had to get the prescription from the healthcare professional prior to buying pills for emergency contraception.

Since 1999, when Plan B entered the market as the prescription-only emergency contraceptive, Duramed, a subsidiary of Barr Pharmaceuticals, has been discussing the OTC status for Plan B with the American FDA, trying to make emergency contraception easier and more convenient for women.

Finally, on August 24 the FDA made it possible for Duramed to sell its products in two variants: with and without prescription. Plan B will be available over-the-counter only for those women, who are at least 18 years old. However, the FDA states in its press-release that OTC Plan B will not be available through convenience stores or other retail outlets because of possible risks of selling the emergency contraception pills to younger women without a prescription.

Prescription versions of Plan B remain available for those, who are under 17 years old, says the American Food and Drug Administration.

Below is the summarized information on Plan B pills.

What is Plan B? Plan B belongs to a group of medications, known as emergency contraceptives. It contains the hormone levonorgestrel. The same working agent, though in significantly lower doses, is used in many common birth control pills. Plan B is neither a birth control pill, which should be taken regularly, nor an abortion pill.

How does Plan B work? Plan B prevents pregnancy by stopping the release of an egg from the ovary, and also by making the fertilization of an egg impossible. It may also prevent the fertilized egg from attaching to the uterus, but it will never affect the existing pregnancy (when the fertilized egg is already attached to the uterus).

How to use Plan B? To prevent pregnancy, two pills of Plan B should be taken: the first one should be taken orally within 3 days after the unprotected sexual intercourse and the second pill should be taken in 12 hours afterwards.

How effective is Plan B? When taken properly, Plan B reduces the chances of pregnancy by up to 89%. Besides, the sooner one takes the pill, the more effective it is.

What side effects are associated with Plan B? It is said that side effects, associated with Plan B, do not differ much from the side effects, typical for the majority of birth control pills. After taking Plan B pills, one may experience nausea, abdominal pain, tiredness, headache, dizziness, or breast tenderness.

Nick


External resources
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html
http://www.fda.gov/cder/drug/infopage/planB/planBQandA20060824.htm
http://www.webmd.com/content/article/126/116441.htm
http://www.go2planb.com/ForConsumers/Index.aspx


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