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Editor: Robert Blanchard
Profession: Attorney at Law

Category: Ortho Evra Medical Information

The Ortho Evra Patch was introduced in 2002 as a relatively "safe" alternative to the birth control pill. Scientists, doctors, and the women who use birth control are generally familiar with the risk associated with "the pill" and have been since the pill was first introduced decades ago, in 1960.

Birth control pills introduced in the 1960's had a much higher dose of Estrogen than was deemed necessary to achieve the desired results. By 1961, doctors were observing much higher risks with blood clots causing heart attacks and strokes and in the years that followed, the doses of Estrogen delivered were lowered significantly.

By the mid-1960's, both the FDA and British studies were researching the risks associated with birth control. While the FDA studies were deemed inconclusive, UK studies found in 1968 that oral contraceptives significantly increased the risk of clotting, and within a year, those findings led to the conclusion that higher incidence of stroke, blood clots or "DVTs", and heart attacks were a direct result of increased Estrogen levels. Recommendations followed to remove all birth control containing higher than 50 micrograms of estrogen be removed from the market.

In 1970, the FDA followed with a warning to physicians of the danger of contraceptives containing higher than 50 mcg of Estrogen, and required drug labeling warning patients and doctors of these risks. The FDA further recommended that estrogen levels in oral contraceptives be lowered to the lowest effective dose.

By 1973, lower-dose oral contraceptives became available and by 1975, all oral birth control introduced contained less than 50 mcg of Estrogen of ethinyl estradiol and by 1987, only 3% of oral contraceptives contained more than 50 micrograms of Estrogen.

Nearly 20 years after the British studies highlighted the risk of injury or death as a result of higher levels of Estrogen in oral contraceptives, the FDA recommended on March 14th, 1988 that all remaining oral birth control containing higher than 50 mcg of Estrogen be removed from the market. The FDA determined that the risks associated with high-level Estrogen oral contraceptives were not worthy of the unsubstantiated benefit over those contraceptives with sub-50 mcg doses of Estrogen.

By 1988, Ortho, Syntrex and G.D. Searle, the last companies selling oral contraceptives containing 50+ mcg of Estrogen agreed to take them off the market. Since then, all oral birth control has contained less than 50 mcg of Estrogen and most contain about half of that amount (between 20-35 mcg of Estrogen).

However, the increased risks caused by the significantly higher dosages of Estrogen released by the patch are at least similar to the dangerous levels seen in early birth control pills offered in the 1960's. The patch releases Estrogen over time and therefore, the dosage levels administer vary widely, resulting in up to a 60% increase in the amount by a 35 mcg dose found in an oral contraceptive, which is at the higher range of current oral contraceptives.