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Appendix C

Classifications for Progestin-Only Contraceptives


Classifications for progestin-only contraceptives (POCs)include those for progestin-only pills, depot medroxyprogesterone acetate, and progestin-only implants (Box). POCs do not protect against sexually transmitted infections (STIs) or human immunodeficiency virus (HIV).

BOX. Categories for Classifying Progestin-Only Contraceptives

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. Classifications for progestin-only contraceptives, including progestin-only pills, DMPA, and implants*

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Personal Characteristics and Reproductive History

Pregnancy

Not applicable

Not applicable

Not applicable

Clarification: Use of POCs is not required. There is no known harm to the woman, the course of her pregnancy, or the fetus if POCs are inadvertently used during pregnancy. However, the relation between DMPA use during pregnancy and its effects on the fetus remains unclear.

Age

a. Menarche to <18 yrs

1

2

1

Evidence: Most studies have found that women lose BMD while using DMPA but regain BMD after discontinuing DMPA. It is not known whether DMPA use among adolescents affects peak bone mass levels or whether adult women with long duration of DMPA use can regain BMD to baseline levels before entering menopause. The relation between DMPA-associated changes in BMD during the reproductive years and future fracture risk is unknown (1--41). Studies find no effect or have inconsistent results about the effects of POCs other than DMPA on BMD (42--54).

b. 18--45 yrs

1

1

1

c. >45 yrs

1

2

1

Parity

a. Nulliparous

1

1

1

b. Parous

1

1

1

Breastfeeding

Clarification: The U.S. Department of Health and Human Services recommends that infants be exclusively breastfed during the first 4--6 months of life, preferably for a full 6 months. Ideally, breastfeeding should continue through the first year of life (55).

Evidence: Despite anecdotal clinical reports that POCs might diminish milk production, direct evidence from available clinical studies demonstrates no significant negative effect of POCs on breastfeeding performance (56--90) or on the health of the infant (66,70,72,76--81,91--93). In general, these studies are of poor quality, lack standard definitions of breastfeeding or outcome measures, and have not included premature or ill infants. Theoretical concerns about effects of progestin exposure on the developing, neonatal brain are based on studies of progesterone effects in animals; whether similar effects occur after progestin exposure in human neonates is not known.

a. <1 mo postpartum

2

2

2

b. 1 mo to <6 mos postpartum

1

1

1

c. ≥6 mos postpartum

1

1

1


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Postpartum (in nonbreastfeeding women)

a. <21 days

1

1

1

b. ≥21 days

1

1

1

Postabortion

Clarification: POCs may be started immediately postabortion.

Evidence: Limited evidence suggests that there are no adverse side effects when implants (Norplant) or progestin-only injectables (NET-EN) are initiated after first trimester abortion (94--97).

a. First trimester

1

1

1

b. Second trimester

1

1

1

c. Immediate postseptic abortion

1

1

1

Past ectopic pregnancy

2

1

1

Comments: POP users have a higher absolute rate of ectopic pregnancy than do users of other POCs but still less than using no method.

History of pelvic surgery

1

1

1

Smoking

a. Age <35 yrs

1

1

1

b. Age ≥35 yrs

i. <15 Cigarettes/day

1

1

1

ii. ≥15 Cigarettes/day

1

1

1

Obesity

a. ≥30 kg/m2 BMI

1

1

1

b. Menarche to <18 yrs and ≥30 kg/m2 BMI

1

2

1

Evidence: Obese adolescents who used DMPA were more likely than obese nonusers, obese COC users, and nonobese DMPA users to gain weight. These associations were not observed among adult women. One small study did not observe increases in weight gain among adolescent Norplant users by any category of baseline weight (98--105).

History of bariatric surgery§

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

1

1

1

Evidence: Limited evidence demonstrated no substantial decrease in effectiveness of oral contraceptives among women who underwent laparoscopic placement of an adjustable gastric band (106).

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

3

1

1

Evidence: Limited evidence demonstrated no substantial decrease in effectiveness of oral contraceptives among women who underwent a biliopancreatic diversion (107); however, evidence from pharmacokinetic studies suggested conflicting results of oral contraceptive effectiveness among women who underwent a jejunoileal bypass (108,109).

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 and/or vomiting.

Cardiovascular Disease

Multiple risk factors for arterial cardiovascular disease (such as older age, smoking, diabetes, and hypertension)

2

3

2

Clarification: When multiple major risk factors exist, risk for cardiovascular disease might increase substantially. Some POCs might increase the risk for thrombosis, although this increase is substantially less than with COCs. The effects of DMPA might persist for some time after discontinuation.

Hypertension

For all categories of hypertension, classifications are based on the assumption that no other risk factors exist for cardiovascular disease. When multiple risk factors do exist, risk for cardiovascular disease might increase substantially. A single reading of blood pressure level is not sufficient to classify a woman as hypertensive.

a. Adequately controlled hypertension

1

2

1

Clarification: Women adequately treated for hypertension are at lower risk for acute myocardial infarction and stroke than are untreated women. Although no data exist, POC users with adequately controlled and monitored hypertension should be at lower risk for acute myocardial infarction and stroke than are untreated hypertensive POC users.


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

b. Elevated blood pressure levels (properly taken measurements)

i. Systolic 140--159 mm Hg or diastolic 90--99 mm Hg

1

2

1

Evidence: Limited evidence suggests that among women with hypertension, those who used POPs or progestin-only injectables had a small increased risk for cardiovascular events than did women who did not use these methods (110).

ii. Systolic ≥160 mm Hg or diastolic ≥100 mm Hg§

2

3

2

c. Vascular disease

2

3

2

Comment: Concern exists about hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA. However, there is little concern about these effects with regard to POPs. The effects of DMPA might persist for some time after discontinuation

History of high blood pressure during pregnancy (where current blood pressure is measurable and normal)

1

1

1

Deep venous thrombosis (DVT)/ Pulmonary embolism (PE)

a. History of DVT/PE, not on anticoagulant therapy

i. Higher risk for recurrent DVT/PE (≥1 risk factors)

• History of estrogen-associated DVT/PE

• Pregnancy-associated DVT/PE

• Idiopathic DVT/PE

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, on therapy, or within 6 mos after clinical remission), excluding non-melanoma skin cancer

• History of recurrent DVT/PE

2

2

2

ii Lower risk for recurrent DVT/PE (no risk factors)

2

2

2

b. Acute DVT/PE

2

2

2

Evidence: No direct evidence exists on use of POCs among women with acute DVT/PE. Although findings on the risk for venous thrombosis with use of POCs in otherwise healthy women is inconsistent, any small increased risk is substantially less than that with COCs (110--112).

c. DVT/PE and established on anticoagulant therapy for at least 3 mos

Evidence: No direct evidence exists on use of POCs among women with DVT/PE on anticoagulant therapy. Although findings on the risk for venous thrombosis with use of POCs are inconsistent in otherwise healthy women, any small increased risk is substantially less than that with COCs (110--112).

Limited evidence indicates that intramuscular injections of DMPA in women on chronic anticoagulation therapy does not pose a significant risk for hematoma at the injection site or increase the risk for heavy or irregular vaginal bleeding (113).

i. Higher risk for recurrent DVT/PE (≥1 risk factors)

• Known thrombophilia, including antiphospholipid syndrome

• Active cancer (metastatic, on therapy, or within 6 mos after clinical remission), excluding non-melanoma skin cancer

• History of recurrent DVT/PE

2

2

2

ii. Lower risk for recurrent DVT/PE (no risk factors)

2

2

2

d. Family history (first-degree relatives)

1

1

1

e. Major surgery

i. With prolonged immobilization

2

2

2

ii. Without prolonged immobilization

1

1

1

f. Minor surgery without immobilization

1

1

1


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Known thrombogenic mutations§ (e.g., factor V Leiden; prothrombin mutation; protein S, protein C, and antithrombin deficiencies)

2

2

2

Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening.

Superficial venous thrombosis

a. Varicose veins

1

1

1

b. Superficial thrombophlebitis

1

1

1

Current and history of ischemic heart disease§

Initiation

Continuation

Initiation

Continuation

Comment: Concern exists about hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA. However, there is little concern about these effects with re

2

3

3

2

3

Stroke§ (history of cerebrovascular accident)

Initiation

Continuation

Initiation

Continuation

Comment: Concern exists about hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA. However, there is little concern about these effects with

2

3

3

2

3

Known hyperlipidemias

2

2

2

Clarification: Routine screening is not appropriate because of the rarity of the conditions and the high cost of screening. Some types of hyperlipidemias are risk factors for vascular disease.

Valvular heart disease

a. Uncomplicated

1

1

1

b. Complicated§ (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis)

1

1

1

Peripartum cardiomyopathy§

a. Normal or mildly impaired cardiac function (New York Heart Association Functional Class I or II: patients with no limitation of activities or patients with slight, mild limitation of activity) (114)

Evidence: No direct evidence exists on the safety of POCs among women with peripartum cardiomyopathy. Limited indirect evidence from noncomparative studies of women with cardiac disease demonstrated few cases of hypertension, thromoboembolism, and heart failure in women with cardiac disease using POPs and DMPA (115,116).

Comment: Progestin-only implants might induce cardiac arrhythmias in healthy women; women with peripartum cardiomyopathy have a high incidence of cardiac arrhythmias.

i. <6 mos

1

1

1

ii. ≥6 mos

1

1

1

b. Moderately or severely impaired cardiac function (New York Heart Association Functional Class III or IV: patients with marked limitation of activity or patients who should be at complete rest) (114)

2

2

2

Evidence: No direct evidence exists on the safety of POCs among women with peripartum cardiomyopathy. Limited indirect evidence from noncomparative studies of women with cardiac disease demonstrated few cases of hypertension, thromoboembolism, and heart failure in women with cardiac disease using POPs and DMPA (115,116).

Comment: Progestin-only implants might induce cardiac arrhythmias in healthy women; women with peripartum cardiomyopathy have a high incidence of cardiac arrhythmias.


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Rheumatic Diseases

Systemic lupus erythematosus (SLE)§

Persons with SLE are at increased risk for ischemic heart disease, stroke, and VTE. Categories assigned to such conditions in the MEC should be the same for women with SLE who present with these conditions. For all categories of SLE, classifications are based on the assumption that no other risk factors for cardiovascular disease are present; these classifications must be modified in the presence of such risk factors.

Many women with SLE can be considered good candidates for most contraceptive methods, including hormonal contraceptives (117--135).

a. Positive (or unknown) antiphospholipid antibodies

Initiation

Continuation

Evidence: Antiphospholipid antibodies are associated with a higher risk for both arterial and venous thrombosis (136,137).

3

3

3

3

b. Severe thrombocytopenia

2

3

2

2

Comment: Severe thrombocytopenia increases the risk for bleeding. POCs might be useful in treating menorrhagia in women with severe thrombocytopenia. However, given the increased or erratic bleeding that may be seen on initiation of DMPA and its irreversibility for 11--13 weeks after administration, initiation of this method in women with severe thrombocytopenia should be done with caution.

c. Immunosuppressive treatment

2

2

2

2

d. None of the above

2

2

2

2

Rheumatoid arthritis

a. On immunosuppressive therapy

1

2/3

1

Clarification: DMPA use among women on long-term corticosteroid therapy with a history of, or with risk factors for, nontraumatic fractures is classified as Category 3. Otherwise, DMPA use for women with rheumatoid arthritis is classified as Category 2.

Evidence: Limited evidence shows no consistent pattern of improvement or worsening of rheumatoid arthritis with use of oral contraceptives (138--143), progesterone (144), or estrogen (145).

b. Not on immunosuppressive therapy

1

2

1

Neurologic Conditions

Headaches

Initiation

Continuation

Initiation

Continuation

Initiation

Continuation

Clarification: Classification depends on accurate diagnosis of severe headaches that are migrainous and headaches that are not. Any new headaches or marked changes in headaches should be evaluated. Classification is for women without any other risk factors for stroke. Risk for stroke increases with age, hypertension, and smoking.

Comment: Aura is a specific focal neurologic symptom. For more information about this and other diagnostic criteria, see: Headache Classification Subcommittee of the International Headache Society. The international classification of headache disorders. 2nd Ed. Cephalalgia. 2004;24 (Suppl 1):1--150. http://www.i-h-s.org/upload/ct_clas/ihc_II_main_no_print.pdf.

Concern exists that severe headaches might increase with use of DMPA and implants. The effects of DMPA may persist for some time after discontinuation.

a. Non-migrainous(mild or severe)

1

1

1

1

1

1

b. Migraine

i. Without aura

• Age <35 yrs

1

2

2

2

2

2

• Age ≥35 yrs

1

2

2

2

2

2

ii. With aura, at any age

2

3

2

3

2

3

Epilepsy§

1

1

1

Clarification: If a woman is taking anticonvulsants, refer to the section on drug interactions. Certain anticonvulsants lower POC effectiveness.

Depressive Disorders

Depressive disorders

1

1

1

Clarification: The classification is based on data for women with selected depressive disorders. No data on bipolar disorder or postpartum depression were available. A potential exists for drug interactions between certain antidepressant medications and hormonal contraceptives.

Evidence: POC use did not increase depressive symptoms in women with depression compared with baseline (146--149).


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Reproductive Tract Infections and Disorders

Vaginal bleeding patterns

a. Irregular pattern without heavy bleeding

2

2

2

Comment: Irregular menstrual bleeding patterns are common among healthy women. POC use frequently induces an irregular bleeding pattern. Implant use might induce irregular bleeding patterns, especially during the first 3--6 months, but these patterns may persist longer.

b. Heavy or prolonged bleeding (includes regular and irregular patterns)

2

2

2

Clarification: Unusually heavy bleeding should raise the suspicion of a serious underlying condition.

Unexplained vaginal bleeding (suspicious for serious condition)

Clarification: If pregnancy or an underlying pathological condition (such as pelvic malignancy) is suspected, it must be evaluated and the category adjusted after evaluation.

Comment: POCs might cause irregular bleeding patterns, which might mask symptoms of underlying pathology. The effects of DMPA might persist for some time after discontinuation.

Before evaluation

2

3

3

Endometriosis

1

1

1

Benign ovarian tumors (including cysts)

1

1

1

Severe dysmenorrhea

1

1

1

Gestational trophoblastic disease

a. Decreasing or undetectable β--hCG levels

1

1

1

b. Persistently elevated β-hCG levels or malignant disease§

1

1

1

Cervical ectropion

1

1

1

Cervical intraepithelial neoplasia

1

2

2

Evidence: Among women with persistent HPV infection, long-term DMPA use (≥5 years) might increase the risk for carcinoma in situ and invasive carcinoma (150).

Cervical cancer (awaiting treatment)

1

2

2

Comment: Theoretical concern exists that POC use might affect prognosis of the existing disease. While awaiting treatment, women may use POCs. In general, treatment of this condition can render a woman sterile.

Breast disease

a. Undiagnosed mass

2

2

2

Clarification: Evaluation should be pursued as early as possible.

b. Benign breast disease

1

1

1

c. Family history of cancer

1

1

1

d. Breast cancer§

i. Current

4

4

4

Comment: Breast cancer is a hormonally sensitive tumor, and the prognosis for women with current or recent breast cancer might worsen with POC use.

ii. Past and no evidence of current disease for 5 years

3

3

3

Endometrial hyperplasia

1

1

1

Endometrial cancer§

1

1

1

Comment: While awaiting treatment, women may use POCs. In general, treatment of this condition renders a woman sterile.

Ovarian cancer§

1

1

1

Comment: While awaiting treatment, women may use POCs. In general, treatment of this condition can render a woman sterile.

Uterine fibroids

1

1

1

Comment: POCs do not appear to cause growth of uterine fibroids.


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Pelvic inflammatory disease (PID)

a. Past PID (assuming no current risk factors for STIs)

Comment: Whether POCs, like COCs, reduce the risk for PID among women with STIs is unknown, but they do not protect against HIV or lower genital tract STI.

i. With subsequent pregnancy

1

1

1

ii. Without subsequent pregnancy

1

1

1

b. Current PID

1

1

1

STIs

a. Current purulent cervicitis or chlamydial infection or gonorrhea

1

1

1

b. Other STIs (excluding HIV and hepatitis)

1

1

1

c. Vaginitis (including Trichomonas vaginalis and bacterial vaginosis)

1

1

1

d. Increased risk for STIs

1

1

1

Evidence: Evidence suggests a possible increased risk for chlamydial cervicitis among DMPA users at high risk for STIs. For other STIs, either evidence exists of no association between DMPA use and STI acquisition or evidence is too limited to draw any conclusions. No evidence is available about other POCs (151--158)

HIV/AIDS

High risk for HIV

1

1

1

Evidence: The balance of the evidence suggests no association between POC use and HIV acquisition, although findings from studies of DMPA use conducted among higher risk populations have been inconsistent (159--183).

HIV infection§

1

1

1

Evidence: Most studies suggest no increased risk for HIV disease progression with hormonal contraceptive use, as measured by changes in CD4 cell count, viral load, or survival. Studies observing that women with HIV who use hormonal contraception have increased risks for STIs are generally consistent with reports among uninfected women. One direct study found no association between hormonal contraceptive use and increased risk for HIV transmission to uninfected partners; several indirect studies reported mixed results about whether hormonal contraception is associated with increased risk for HIV-1 DNA or RNA shedding from the genital tract (171,184--200).

AIDS§

1

1

1

Clarification: Drug interactions might exist between hormonal contraceptives and ARV drugs; refer to the section on drug interactions.

Other Infections

Schistosomiasis

a. Uncomplicated

1

1

1

Evidence: Among women with uncomplicated schistosomiasis, limited evidence showed that DMPA use had no adverse effects on liver function (201).

b. Fibrosis of liver§(if severe, see cirrhosis)

1

1

1

Tuberculosis§

Clarification: If a woman is taking rifampicin, refer to the section on drug interactions. Rifampicin is likely to decrease the effectiveness of some POCs.

a. Nonpelvic

1

1

1

b. Pelvic

1

1

1

Malaria

1

1

1


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Endocrine Conditions

Diabetes

a. History of gestational disease

1

1

1

Evidence: POCs had no adverse effects on serum lipid levels in women with a history of gestational diabetes in 2 small studies. (202,203) Limited evidence is inconsistent about the development of noninsulin-dependant diabetes among users of POCs with a history of gestational diabetes (204--207).

b. Nonvascular disease

i. Noninsulin-dependent

2

2

2

Evidence: Among women with insulin- or noninsulin-dependent diabetes, limited evidence on use of POCs (POPs, DMPA, LNG implant) suggests that these methods have little effect on short-term or long-term diabetes control (e.g., glycosylated hemoglobin levels), hemostatic markers, or lipid profile (208--211).

ii. Insulin-dependent§

2

2

2

c. Nephropathy/retinopathy/ neuropathy§

2

3

2

Comment: Concern exists about hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA. The effects of DMPA might persist for some time after discontinuation. Some POCs might increase the risk for thrombosis, although this increase is substantially less than with COCs.

d. Other vascular disease or diabetes of >20 yrs' duration§

2

3

2

Comment: Concern exists about hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA. The effects of DMPA might persist for some time after discontinuation. Some POCs might increase the risk for thrombosis, although this increase is substantially less than with COCs.

Thyroid disorders

a. Simple goiter

1

1

1

b. Hyperthyroid

1

1

1

c. Hypothyroid

1

1

1

Gastrointestinal Conditions

Inflammatory bowel disease (IBD) (ulcerative colitis, Crohn disease)

2

2

1

Evidence: Risk for disease relapse among women with IBD using oral contraceptives (most studies did not specify formulation) did not increase significantly from that for nonusers (212--216).

Comment: Absorption of POPs among women with IBD might be reduced if the woman has substantial malabsorption caused by severe disease or small bowel surgery.

Women with IBD have a higher prevalence than the general population of osteoporosis and osteopenia. Use of DMPA, which has been associated with small changes in BMD, might be of concern.

Gallbladder disease

a. Symptomatic

i. Treated by cholecystectomy

2

2

2

ii. Medically treated

2

2

2

iii. Current

2

2

2

b. Asymptomatic

2

2

2

History of cholestasis

a. Pregnancy-related

1

1

1

b. Past COC--related

2

2

2

Comment: Theoretically, a history of COC-related cholestasis might predict subsequent cholestasis with POC use. However, this has not been documented.

Viral hepatitis

a. Acute or flare

1

1

1

b. Carrier

1

1

1

c. Chronic

1

1

1


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Cirrhosis

a. Mild (compensated)

1

1

1

b. Severe§ (decompensated)

3

3

3

Liver tumors

a. Benign

Evidence: Limited direct evidence suggests that hormonal contraceptive use does not influence either progression or regression of liver lesions among women with focal nodular hyperplasia (217,218).

Comment: No evidence is available about hormonal contraceptive use among women with hepatocellular adenoma. COC use in healthy women is associated with development and growth of hepatocellular adenoma; whether other hormonal contraceptives have similar effects is not known.

i. Focal nodular hyperplasia

2

2

2

ii. Hepatocellular adenoma§

3

3

3

b. Malignant§ (hepatoma)

3

3

3

Anemias

Thalassemia

1

1

1

Sickle cell disease§

1

1

1

Evidence: Among women with sickle cell disease, POC use did not have adverse effects on hematologic parameters and, in some studies, was beneficial with respect to clinical symptoms (219--226).

Iron deficiency anemia

1

1

1

Comment: Changes in the menstrual pattern associated with POC use have little effect on hemoglobin levels.

Solid Organ Transplantation

Solid organ transplantaton§

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

2

2

2

b. Uncomplicated

2

2

2

Drug Interactions

Antiretroviral (ARV) therapy

Clarification: ARV drugs have the potential to either decrease or increase the bioavailability of steroid hormones in hormonal contraceptives. Limited data (Appendix M) suggest potential drug interactions between many ARV drugs (particularly some NNRTIs and ritonavir-boosted protease inhibitors) and hormonal contraceptives. These interactions may alter the safety and effectiveness of both the hormonal contraceptive and the ARV drug. Thus, if a woman on ARV treatment decides to initiate or continue hormonal contraceptive use, the consistent use of condoms is recommended to both prevent HIV transmission and compensate for any possible reduction in the effectiveness of the hormonal contraceptive.

a. Nucleoside reverse transcriptase inhibitors (NRTIs)

1

1

1

b. Non-nucleoside reverse transcriptase inhibitors (NNRTIs)

2

1

2

c. Ritonavir-boosted protease inhibitors

3

1

2

Anticonvulsant therapy

a. Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)

3

1

2

Clarification: Although the interaction of certain anticonvulsants with POPs and ETG implants is not harmful to women, it is likely to reduce the effectiveness of POPs and ETG implants. Whether increasing the hormone dose of POPs alleviates this concern remains unclear. Use of other contraceptives should be encouraged for women who are long-term users of any of these drugs. Use of DMPA is a Category 1 because its effectiveness is not decreased by use of certain anticonvulsants.

Evidence: Use of certain anticonvulsants may decrease the effectiveness of POCs (227--229)

b. Lamotrigine

1

1

1

Evidence: No drug interactions have been reported among epileptic women taking lamotrigine and using POCs (230)


TABLE. (Continued) Classifications for progestin-only contraceptives,*including progestin-only pills, DMPA, and implants

Condition

Category

Clarifications/Evidence/Comments

POP

DMPA

Implants

Antimicrobial therapy

a. Broad-spectrum antibiotics

1

1

1

b. Antifungals

1

1

1

c. Antiparasitics

1

1

1

d. Rifampicin or rifabutin therapy

3

1

2

Clarification: Although the interaction of rifampicin or rifabutin with POPs and ETG implants is not harmful to women, it is likely to reduce the effectiveness of POPs and ETG implants. Use of other contraceptives should be encouraged for women who are long-term users of any of these drugs. Use of DMPA is a Category 1 because its effectiveness is not decreased by use of rifampicin or rifabutin. Whether increasing the hormone dose of POPs alleviates this concern remains unclear.

* Abbreviations: STI = sexually transmitted infection; HIV = human immunodeficiency virus; POC = progestin-only contraceptive; DMPA = depot medroxyprogesterone acetate; BMD = bone mineral density; NET-EN = norethisterone enantate; BMI = body mass index; COC = combined oral contraceptive; HDL = high-density lipoprotein; POP = progestin-only pill; DVT = deep venous thrombosis; PE = pulmonary embolism; SLE = systemic lupus erythematosus; VTE = venous thromboembolism; MEC = Medical Eligibility Criteria; hCG = human chorionic gonadotropin; HPV = human papillomavirus; PID = pelvic inflammatory disease; AIDS = acquired immunodeficiency syndrome; IBD = inflammatory bowel disease; ARV = antiretroviral; LNG = levonorgestrel; NRTI = nucleoside reverse transcriptase inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor; ETG = etonogestrel.

POCs do not protect against STI/HIV. If risk exists for STI/HIV (including during pregnancy or postpartum), the correct and consistent use of condoms is recommended, either alone or with another contraceptive method. Consistent and correct use of the male latex condom reduces the risk for STIs and HIV transmission.

§ Condition that exposes a woman to increased risk as a result of unintended pregnancy.

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