Reinforce instructions after Micronor alert

Check your inventory of Ortho Micronor progestin-only pills. While there are no problems with the pills themselves, certain lots of the drug contain incorrect information in the patient leaflet that, if followed, could compromise the drug’s efficacy.

According to the pill manufacturer, Ortho-McNeil Pharmaceutical of Raritan, NJ, certain lots of the drug contain incorrect information in the patient leaflet, which Ortho-McNeil refers to as the Detailed Patient Labeling. The following incorrect statement is found under the heading "Instructions for Using Your DIALPAK Tablet Dispenser":

"If you miss any of pills 22 through 28, you will still be protected."

The company issued an advisory on April 4, 2002, citing the following Ortho Micronor product lot numbers:

  • 11M001;
  • 11M002;
  • 11M019;
  • 12A029;
  • 12C003;
  • 12C004;
  • 12C030.

About 500,000 cycles of the drug were involved in the alert, says Kellie McLaughlin, director of global pharmaceutical communications for New Brunswick, NJ-based Johnson & Johnson, Ortho-McNeil’s parent company. The lot numbers were shipped starting Jan. 30, 2002. New shipments have been suspended until new patient leaflets can be printed, packaged, and shipped with the product. The advisory only addresses Ortho Micronor pills; none of the other eight birth control pills marketed by Ortho-McNeil are included in the alert.

Health care providers and pharmacists have been asked to check product lot numbers, remove the incorrect patient leaflet, and insert the correct leaflet when dispensing the product, says McLaughlin. Direct purchasing chains and wholesale distributors have been asked to return the product lots in question, she states. (The corrected patient leaflet, as well as a health care professional letter, frequently-asked question sheet, and press release, are available at www.orthomicronor.com. Click on "Important Alert About Ortho Micronor," then click on the links for each item.) Providers who have further questions may contact the company’s customer communications center at (800) 632-7497.

According to the company, women taking Ortho Micronor, or any progestin-only birth control pill, should take one pill every day without any breaks for maximum effectiveness.1 Women who miss one pill should take the missed pill as soon as possible and continue taking a pill each day at the regular time, the company advises. A backup method of birth control (such as a condom or spermicide) must be used for the next 48 hours. Women who miss more than one pill should use a backup method of birth control and contact a health care professional immediately, states the company. (According to A Pocket Guide to Managing Contraception, if a woman misses a pill by more than three hours from her regular time, she should take the missed pill(s) and use backup contraception for seven days. She should consider using emergency contraception if intercourse occurred in the past three to five days.)2

Same time, every day

Although not widely used in the United States, progestin-only pills offer an important contraceptive option since they may be used by women who desire immediately reversible hormonal protection but who have contraindications to the estrogen in combined pills. Unlike combined oral contraceptives, progestin-only pills are taken continuously, with no hormone-free intervals between cycles. (For a review of progestin-only pills, see "Maximizing the use of the progestin minipill," Contraceptive Technology Update, February 1999, p. 19.)

Three progestin-only pills are available in the United States: Ortho Micronor, Nor-QD (Watson Laboratories, Corona, CA), and Ovrette (Wyeth-Ayerst Laboratories, Philadelphia.) Ortho Micronor contains 0.35 mg of the progestin norethindrone, as does Nor-QD; Ovrette contains 0.075 mg of norgestrel.

Among typical couples who use progestin-only pills, about 5% will experience an accidental pregnancy in the first year.2 However, if the pills are used consistently and correctly, just one in 200 women will become pregnant.2

Progestin-only OCs, often referred to as minipills, are formulated at a very low dose, so low in fact that ovulation often occurs in those using this method of contraception, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. If users are not "religious" in consistently taking tablets at the same time each day, the anti-fertility impact of the minipills (including cervical mucus changes) may diminish, permitting fertilization, he states.

In the United States, the great majority of mini-pill users are nursing mothers, Kaunitz observes. Progestin-only pills represent a good contraception option for such women, since they have no adverse effects on lactation. Most research has found either that they have positive effects — increasing milk quantity or improving its nutritional quality — or that they have no effect.3 Women who choose progestin-only pills can use them and continue to breast-feed until lactation cessation.3

Because lactating women are intrinsically subfertile, precautions regarding taking minipills at the same time each day may not be critical, Kaunitz notes. However, highly fertile women relying on minipills for contraception, as well as their clinicians, should pay close attention to well-timed consistent daily pill-taking, he states.

References

1. Ortho-McNeil Pharmaceutical. Urgent Labeling Correction — Detailed Patient Labeling Error. Raritan, NJ; April 4, 2002.

2. Hatcher RA, Nelson AL, Zieman M, et al. A Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2001.

3. Blackburn RD, Cunkelman JA, Zlidar VM. Oral contraceptives: An update. Population Reports Spring 2000; Series A (No. 9):5.