Advocates Push for OTC Access To Emergency Contraceptive Pills.

NEW YORK -- The debate over whether women or their physicians should control access to oral contraceptives is moving into the territory of emergency contraception.

While a quiet debate has persisted for decades as to whether oral contraceptives should be made available without a prescription, safety concerns have made such a move unlikely But safety issues associated with long-term use of hormonal preparations do not exist with the two currently available emergency contraceptive products Preven (levonorgestrel and ethinyl estradiol) and Plan B (levonorgestrel), Dr. Carolyn Westhoff said at a press briefing on emergency contraception sponsored by the Kaiser Family Foundation.

Preven, which first came on the market in 1998, is a combined estrogen-progestin pill, while Plan B, available since 1999, is a progestin-only "minipill." With both products, one pill must be taken within 72 hours of unprotected intercourse and a second pill, 12 hours later.

In answer to a question about possible untoward medical effects occurring with "a huge blast of hormones" contained in emergency contraceptive pills (ECPs), Dr. Westhoff explained that a single 2-pill emergency contraception dose is equivalent to only 3 days' worth of low-dose contraceptives and to only one pill of the first-generation higher-dose contraceptives used by millions in the 1960s and 1970s.

Emergency contraception is "safe, safe, safe," said Dr. Westhoff, professor of obstetrics, gynecology and public health at Columbia University in New York.

While the window of opportunity for beginning ECP use is within 72 hours, optimal efficacy is seen when the first pill is taken within 12 hours of unprotected sex, and several women's health advocacy groups are questioning why these drugs should not be accorded OTC status.

Indeed, the American Medical Association's House of Delegates recently passed a resolution stating that the organization would support over-the-counter access to ECPs if the Food and Drug Administration determined they were safe for use without a prescription. (See related story on p. 3.)