"To B or not to B...": Comments on FDA Approval of Plan B

In my last post, I discussed the high rates of maternal mortality related mostly to complications of bleeding and infection in the U.S. prior to the era of modern care that really began in the 1940’s with the availability of antibiotics and blood products. What I intentionally omitted from the discussion was that many “obstetrical” deaths prior to this and, unfortunately, for many years afterwards, were the result of illegal abortions. Today, in developing nations and in countries that ban abortion, “unsafe abortion” is still a major cause of maternal morbidity and mortality.

With regard to the above, August 24, 2006, marked a milestone that should be noted in its significance even in a blog devoted to obstetrical care and childbirth. That milestone is the FDA approval of Plan B® as an over-the-counter (OTC) medication for emergency contraception in women 18 years and older. Plan B® provides another option to women for prevention of a pregnancy that is not planned or desired. It has been available as a prescription medication since 1999, and a prescription will still be required for women less than 18 years of age.

Plan B® contains a synthetic progesterone (levonorgestrel) only that has been used in birth control pills for more than 35 years and has a well-established safety record. Progesterone is the hormone that dominates the second half of the menstrual cycle after ovulation occurs and its continued production is important for the maintenance of a normal pregnancy. As such Plan B is highly unlikely to cause interruption of a pregnancy that is already established.

Plan B® should not be considered a substitute for regular and ongoing contraception in women who do not wish to conceive. It is also not inexpensive, costing approximately $40.00 per two-tablet course of therapy, and will only be dispensed from a pharmacy to a woman with proof of age. However, it does obviate the need, the delay, and the additional expense and lack of privacy associated with a physician appointment or a trip to the local emergency room or urgent care center. It should not replace a visit to a professional in instances of rape or exposure to a partner at high risk for carriage of a sexually transmitted infection.

The first tablet of Plan B® should be taken within 72 hours of failed contraception and, the earlier, the better. The second tablet is taken 12 hours after the first. Side effects are usually minimal, including nausea, vomiting, dizziness, breast tenderness, and aberration of normal menstrual bleeding. Overall success rates are in the range of 90%. If menstrual bleeding does not occur within a week of the expected time, the woman should get a pregnancy test performed. If the patient is pregnant already, or conceives despite having taken Plan B®, the drug is unlikely to cause birth defects.

Two years ago The FDA turned down the application to provide Plan B® as an OTC product amid accusations of “political pressure.” Despite denials of this, the FDA did appear to make a decision that largely ignored the data supporting the safety of Plan B® and stretched for reasons to deny the application. The reversal of this initial decision is a victory not only for women, but also for the scientific process of “evidence-based” medicine.

Permalink | Email Post