Magazine article Drug Topics

Make Way for Progestin-Only Emergency Contraceptive

Magazine article Drug Topics

Make Way for Progestin-Only Emergency Contraceptive

Article excerpt

NEW

DRUG

The growing emergency contraceptive market has acquired an addition-the first Food & Drug Administration-approved progestinonly product, intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. Made available in the United States by Women's Capital Corp. (WCC), the Plan B package is about the size of a woman's compact and consists of two tablets of levonorgestrel, 0.75 mg. The initial pill should be taken within 72 hours of unprotected sex, and the second pill is taken 12 hours later.

The currently available hormonalbased emergency contraceptive options include:

The traditional Yuzpe method-a regimen that consists of 100 mcg of ethinyl estradiol and 0.25 mg of levonorgestrel obtained from various oral contraceptive products and initiated within 72 hours after intercourse and repeated 12 hours later. Preven kit (levonorgestrel and ethinyl estradiol)-a prepackaged product containing only the four needed pills, a patient information booklet, and a pregnancy test.

The main advantage of a progestinonly product appears to be tolerability. Of the 3,000 women who received Plan B in the World Health Organization-sponsored clinical trials, 21% and 5.6% of them experienced nausea and vomiting, respectively. The Yuzpe regimen usually produces a 50% incidence of nausea and approximately a 20% incidence of vomiting. As a consequence, repeat dosing-if vomiting occurs within two hours of ingestion-and subsequent prophylactic antiemetic agents are often necessary with this regimen. Yvonne Biu, Pharm.D., a pharmacist at Fairwood Pharmacy in Renton, Wash., noted that in her facility, the Yuzpe regimen is dispensed along with the antiemetic promethazine.

Maria T Britto, M.D., MPH, who spoke about women's health issues at this year's annual meeting of the American College of Clinical Pharmacy, believes that a progestin-only regimen, already available in Europe, will become the preferred emergency contraceptive in the United States because of its favorable safety profile. The Plan B product, however, is not devoid of side effects. A portion of studied patients (10% to 17%) experienced abdominal pain, fatigue, headache, heavier or lighter menstrual bleeding, dizziness, and breast tenderness.

Plan B has been shown to decrease the risk of pregnancy from approximately 8% to 1%. This represents an 89% reduction in the risk of the event following a single act of unprotected intercourse. According to Biu, the Yuzpe method provides a 75% reduction in the risk of pregnancy. …

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