Labeling has caused "incredible confusion"
Contraceptive Technology Update 16(4): 49-51
1995
ISSN/ISBN: 0274-726X PMID: 12347027 Document Number: 295933
The US Food and Drug Administration is considering changing the package labeling for the mini-pill to eliminate confusion about when to prescribe it. However, differing opinions about some related issues are hard to reconcile, to wit: whether breast feeding women should use progestin-only pills (POPs) or combined oral contraceptives (COCs). Less than 1% of American pill users rely on POPs, therefore manufacturers did not think it worthwhile to produce a separate insert for them. However, the shared insert has caused confusion. First-year failure rates for POPs range from 1.1% to 13.2%, but for lactating women they are nearly 100% effective if taken 3 weeks after delivery every day as a backup method. The consensus seems to be that POPs are used during lactation, and that at weaning or when menstruation returns women should switch to COCs. This should be done even if women were doing fine on POPs during breastfeeding, because POPs are less effective, cause irregular bleeding, and are implicated in a higher rate of ectopic pregnancies. In contrast to this opinion, another view is that prescribing COCs to breastfeeding women is acceptable, although lower-dose cyclic pills are preferred. Either pill would be acceptable for breastfeeding women according to a committee chair of the American Association of Pediatricians. Another option is to let the women decide themselves, especially if they have high blood pressure and do not like implants and injectables. For clients who choose POPs providers should assume that they comply with pill use; they should get feedback from them about the effectiveness of the pills; and they should allow them to have time to make a decision that would serve them in the long run.