FDA Approves "morning-after" Pill

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Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs
Article Date: 25 Aug 2006 - 6:00 PDT


After 3 years of debate the US Food and Drug Administration (FDA) has decided to approve sales of a "morning-after" contraceptive pill without a prescription. Plan B, manufactured by Barr Pharmaceuticals Inc, can be sold to over 18s in the United States without a prescription, but must remain off pharmacy shelves to prevent those aged under 18 from obtaining the drug without doctors orders. 17 year olds and under will still need to have a prescription to buy Plan B.

Plan B will be available only in pharmacies and the FDA has ruled that women or men must show ID proving they are over 18 to purchase the drug - this decision has disappointed some parties who had hoped for wider access saying that the drug could halve the number of unplanned pregnancies in the United States. There are estimated to be up to 3 million unplanned pregnancies annually in the US, of which 850,000 occur in teenagers.

Some Conservative groups are also upset by the decision, arguing that making Plan B available "over-the-counter" could increase promiscuity and think that the use of Plan B is equivalent to abortion.

The FDA said that Plan B, available on prescription in the US since 1999, was safe and affective for women when taken as directed, but should not be used routinely. Studies show that Plan B can reduce the risk of pregnancy occurring by up to 89% if taken within 72 hours of sex and is most effective if taken within 24 hours.

Plan B is, in effect, a concentrated version of existing contraceptive pills that contains higher doses of progestin. Women are directed to take 2 pills 12 hours apart which block the release or prevent fertilization of an egg. Potential side effects are similar to those experienced by some women when using regular birth-control pills and include nausea, stomach pain, headaches, dizziness or breast tenderness. The pills currently cost between $25 and $40 on prescription, Barr Pharmaceuticals Inc. have not indicated they will change this cost and say that they hope to begin over-the-counter sales later this year.

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Written by: Peter Hill
Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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