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US Medical Eligibility Criteria (US MEC) for Contraceptive Use

Classifications for Emergency Contraception

 

A copper-containing intrauterine device (Cu-IUD) can be used within 5 days of unprotected intercourse as an emergency contraceptive. However, when the time of ovulation can be estimated, the Cu-IUD can be inserted beyond 5 days after intercourse, if necessary, as long as the insertion does not occur >5 days after ovulation. The eligibility criteria for interval Cu-IUD insertion also apply for the insertion of Cu-IUDs as emergency contraception (Box J1) (Table J1).

Classifications for emergency contraceptive pills (ECPs) are given for ulipristal acetate (UPA), levonorgestrel (LNG), and combined oral contraceptives (COCs). Cu-IUDs, UPA, LNG, and COCs do not protect against sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), and women using these methods should be counseled that consistent and correct use of the male latex condom reduces the risk for transmission of HIV and other STDs. Use of female condoms can provide protection from transmission of STDs, although data are limited.

 

BOX J1. Categories for classifying emergency contraception

1 = A condition for which there is no restriction for the use of the contraceptive method.

2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.

3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.

4 = A condition that represents an unacceptable health risk if the contraceptive method is used.

TABLE J1. Classifications for emergency contraception, including the copper-containing intrauterine device, ulipristal acetate, levonorgestrel, and combined oral contraceptives

Condition

Category

Clarifications/Evidence/Comments

Cu-IUD

UPA

LNG

COC

Personal Characteristics and Reproductive History

Pregnancy

4

NA

NA

NA

Clarification (IUD): The IUD is not indicated during pregnancy and should not be used because of the risk for serious pelvic infection and septic spontaneous abortion.

Clarification (ECPs): Although this method is not indicated for a woman with a known or suspected pregnancy, no harm to the woman, the course of her pregnancy, or the fetus if ECPs are inadvertently used is known to exist.

Evidence: Evidence suggests that poor pregnancy outcomes are rare among pregnant women who used ECPs during conception cycle or early in pregnancy (1).

Breastfeeding

1

1

1

1

Clarification (UPA): Breastfeeding is not recommended for 24 hours after taking UPA because it is excreted in breast milk, with highest concentrations in the first 24 hours, and maximum maternal serum levels are reached 1–3 hours after administration. Mean UPA concentrations in breast milk decrease markedly from 0 to 24–48 hours and then slowly decrease over 5 days (2). Breast milk should be expressed and discarded for 24 hours after taking UPA.

Evidence: Breastfeeding outcomes do not seem to differ between women exposed to LNG and those who are not exposed. One pharmacokinetic study demonstrated that LNG passes to breast milk but in minimal quantities (1).

Past ectopic pregnancy

1

1

1

1

History of bariatric surgery
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).

 

 

 

 

 

a. Restrictive procedures: decrease storage capacity of the stomach (vertical banded gastroplasty, laparoscopic adjustable gastric band, or laparoscopic sleeve gastrectomy)

1

1

1

1

b. Malabsorptive procedures: decrease absorption of nutrients and calories by shortening the functional length of the small intestine (Roux-en-Y gastric bypass or biliopancreatic diversion)

1

1

1

1

Comment: Bariatric surgical procedures involving a malabsorptive component have the potential to decrease oral contraceptive effectiveness, perhaps further decreased by postoperative complications such as long-term diarrhea, vomiting, or both. Because of these malabsorptive concerns, an emergency IUD might be more appropriate than ECPs.

Cardiovascular Disease

History of severe cardiovascular disease (ischemic heart disease, cerebrovascular attack, or other thromboembolic conditions)
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).

1

2

2

2

Comment: The duration of ECP use is less than that of regular use of COCs or POPs and thus would be expected to have less clinical impact.

Rheumatic Diseases

Rheumatoid arthritis

 

 

 

 

 

a. Receiving immunosuppressive therapy

2

1

1

1

b. Not receiving immunosuppressive therapy

1

1

1

1

Neurologic Conditions

Migraine

1

1

1

2

Comment: The duration of ECP use is less than that of regular use of COCs and thus would be expected to have less clinical impact.

Gastrointestinal Conditions

Inflammatory bowel disease (ulcerative colitis or Crohn’s disease)

1

1

1

1

Severe liver disease (including jaundice)
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).

1

2

2

2

Comment: The duration of ECP use is less than that of regular use of COCs or POPs and thus would be expected to have less clinical impact.

Solid Organ Transplantation

Solid organ transplantation
This condition is associated with increased risk for adverse health events as a result of pregnancy (Box 2).

 

 

 

 

 

a. Complicated: graft failure (acute or chronic), rejection, or cardiac allograft vasculopathy

3

1

1

1

b. Uncomplicated

2

1

1

1

Other

Repeated ECP use

1

1

1

1

Clarification: Recurrent ECP use is an indication that the woman requires further counseling about other contraceptive options. Frequently repeated ECP use might be harmful for women with conditions classified as 2, 3, or 4 for CHC or POC use.

Evidence: In one case-control study, risk for ectopic pregnancy compared with intrauterine pregnancy did not increase after repeated use of LNG ECPs compared with nonuse (1).

Sexual assault

2

1

1

1

Clarification (IUD): Women who have experienced sexual assault are at increased risk for STDs. According to CDC STD treatment guidelines, routine presumptive treatment of chlamydia, gonorrhea, and trichomonas is recommended after sexual assault (3). Women with current purulent cervicitis or chlamydial infection or gonococcal infection should not undergo IUD insertion (category 4).

Obesity (BMI ≥30 kg/m2)

1

2

2

2

Clarification (ECPs): ECPs might be less effective among women with BMI ≥30 kg/m2 than among women with BMI <25 kg/m2. Despite this, no safety concerns exist.

Evidence: Limited evidence from secondary data analyses suggests that women with BMI ≥30 kg/m2 experience an increased risk for pregnancy after use of LNG compared with women with BMI <25 kg/m2. Two analyses suggest obese women might also experience an increased risk for pregnancy after use of UPA compared with nonobese women, although this increase was not significant in one study (4).

CYP3A4 inducers (e.g., bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, topiramate, efavirenz, and lumacaftor)

1

2

2

2

Clarification (ECPs): Strong CYP3A4 inducers might reduce the effectiveness of ECPs.

Evidence: According to labelling information, rifampin markedly decreases UPA levels by ≥90%, which might decrease its efficacy (2). Therefore, theoretical concerns extend to use of other CYP3A4 inducers as well as to COC and LNG ECPs, which have metabolic pathways similar to those of UPA. A small pharmacokinetic study found that concomitant efavirenz use decreased LNG levels in women taking LNG ECPs (0.75 mg) by 56% compared with LNG ECPs alone (5).

Abbreviations: BMI = body mass index; CHC = combined hormonal contraceptive; COC = combined oral contraceptive; Cu-IUD = copper-containing intrauterine device; ECP = emergency contraceptive pill; HIV = human immunodeficiency virus; IUD = intrauterine device; LNG = levonorgestrel; NA = not applicable; POC = progestin-only contraceptive; POP = progestin-only pill; STD = sexually transmitted disease; UPA = ulipristal acetate.

References

  1. Jatlaoui TC, Riley H, Curtis KM. Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception. Contraception 2016;93:93–112. http://dx.doi.org/10.1016/j.contraception.2015.11.001 PubMed
  2. Watson Pharmaceuticals. Ella [Prescribing information]. Morristown, NJ; 2010. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf
  3. Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015;64(No. RR-03). PubMed
  4. Jatlaoui TC, Curtis KM. Safety and effectiveness data for emergency contraceptive pills among women with obesity: a systematic review. Contraception 2016. Epub May 24, 2016. http://dx.doi.org/10.1016/j.contraception.2016.05.002
  5. Carten ML, Kiser JJ, Kwara A, Mawhinney S, Cu-Uvin S. Pharmacokinetic interactions between the hormonal emergency contraception, levonorgestrel (Plan B), and efavirenz. Infect Dis Obstet Gynecol 2012;2012:137192.

 

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