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FDA Considers Lowering Acceptable “Failure” Rate on Approved Contraceptive Pills

By Hilary White

WASHINGTON, January 24, 2007 (LifeSiteNews.com) – The US Food and Drug Administration is reconsidering contraceptives, but only to make sure they are more effective at preventing – or ending – a pregnancy. The FDA has asked an expert panel whether it ought to ensure higher standards of “effectiveness” of new hormonal contraceptive/abortifacient drugs before approval for the market. The 14 member panel of outside experts met this week to advise the agency on future guidelines for drug manufacturers seeking approval.

The pills approved by the FDA in 1960 contained much higher doses of hormones than modern pills and had a lower “failure” rate, approximately 1 in 100 “woman-years” of use. That is, one woman in one hundred using the drug for a year became pregnant. The dangerous side effects of the high dose drug prompted the development of lower dose versions.

In recent years, the FDA has approved lower doses of the pill, though studies have shown that they allow more pregnancies to occur and also still have serious side effects. The agency has approved pills allowing more than two pregnancies for every 100 woman-years of use.

According to a 2005 study by Planned Parenthood’s Guttmacher Institute, 11.6 million US women use hormonal birth control pills.

The pill has three main actions: to suppress ovulation; thicken the cervical mucus making it difficult for sperm to reach the ovum; and to alter the lining of the uterus so that the zygote cannot implant. The last action is directly abortifacient since the zygote is the first stage of human development.

Low-dose pills are less effective at preventing ovulation and therefore rely more on the remaining two functions.

Possible side effects of low-dose pills, apart from the possible death of already-conceived children, include blood clots and cardiovascular problems. One recent study showed that woman have a 100 per cent increase in risk of heart attack and stroke with the low-dose pill.

A spokesman for the FDA, Karen Riley said the agency considers all the contraceptives it approves to be safe and effective.

Read related LifeSiteNews.com coverage:
Parents Sue After 14-Year-Old Daughter Died with Birth Control Patch
http://www.lifesitenews.com/ldn/2005/nov/05112102.html

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