Fear May Drive Women to Take Unnecessary Risks of Plan B

Women may be risking exposure to hormones when they aren't even pregnant.

(Apr. 27, 2009) Women who rush to buy Plan B after having unprotected sexual intercourse may be unnecessarily exposing themselves to dangerously high levels of hormones, says a Chicago-area pregnancy center.

Plan B’s hormone dosage is ten times higher than that of normal birth control pills using the same hormone, according to FDA research. Taking it may be unnecessary, depending upon when a woman has had intercourse during her cycle, says WomanCare Services in Berwyn, IL.

It has been WomanCare Services’ experience that most of their clients interested in Plan B are probably not fertile at the time they come for a consultation.

Before FDA’s 2006 approval of Plan B, distributed by Duramed Pharmaceuticals, FDA researcher Alex Jordan testified that “this high dose, which is 10 times higher than the normal OC [oral contraceptive] dose, could be fairly androgenic and might have the potential of masculinizing the fetus if the woman takes it while pregnant.”¹ See FDA Jordan report (PDF).

In another testimony, researcher Peter M. Vander Bleek testified to the FDA during the Plan B’s hearings that Barr Labs, the manufacturer of Plan B, should acknowledge that “the effects of a drug therapy are often as dependent on the dosage level of a drug as they are on the drug itself.”² See FDA Bleek testimony.

Drug labeling for Plan B states that common side effects associated with it include “nausea, vomiting, stomach pain, tiredness, diarrhea, dizziness, breast pain, headache, and menstrual changes.”³

Women in Berwyn, Cicero, N. Riverside, Forest Park and other nearby communities in Illinois who have forgotten to take their birth control pill, or who had unprotected sex should first determine the likelihood of getting pregnant at that point in their cycles before running the risks of Plan B side effects. They can call WomanCare Services at 708-795-6000 for a free consultation before taking Plan B.

Sources

1. “Levonorgestrel is an approved progestin in oral contraceptives. The current maximum dose for oral contraceptives is 0.15 mg/day. The dose recommended for emergency contraception is 1.5 mg. [Two tablets of 0.75 mg. each] ... This high dose which is 10 times higher than the normal OC dose, could be fairly androgenic and might have the potential of masculinizing the fetus if the woman takes it while pregnant. However, there is apparently no evidence of this from the animal teratology studies, or from the limited number of human experiences.” (Alex Jordan, FDA Center for Drug Evaluation and Research. See FDA Jordan report (PDF))

2. “I am certain that an OTC version of Plan B will tout itself—as has its prescription counterpart—as a ‘regular birth control pill.’ This false information is a risk that our public simply cannot afford.” (See FDA Bleek testimony.)

3. FDA Drug labeling for Plan B.

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