Oral Contraceptive Pills (OCPs) - Risk Factors, Dose & Side Effects

1. Types and Formulations

• Contain ethinyl estradiol (EE) + a progestin
• Monophasic: constant dose of both hormones throughout cycle
• Triphasic: constant estrogen with increasing progestin doses (mimics natural cycle)
• Standard regimen: 21 active pills + 7 placebo (28-day pack); withdrawal bleeding occurs in hormone-free interval
• Extended cycle: 84 active + 7 placebo - less frequent withdrawal bleeding
• Continuous use: active pills every day (no withdrawal bleed)

2. Risk Factors That Increase OCP Hazards

• Smoking (especially >15 cigarettes/day in women >35 yrs) - increases thromboembolism risk dramatically; low-dose OCPs are absolutely contraindicated in this group
• Hypertension (BP ≥140/90 at 3 visits or diastolic >110 at one visit)
• Prior thromboembolism, DVT, PE, CVA, or MI
• Coronary artery disease
• Factor V Leiden mutation or other thrombophilias
• Congenital hyperlipidemia
• Obesity (BMI ≥30 - especially with transdermal patch, which delivers higher systemic estrogen)
• Diabetes mellitus
• Age >35 years (particularly combined with smoking)

• Known or suspected breast carcinoma
• Known or suspected estrogen-dependent neoplasia (e.g., endometrial carcinoma)
• Liver neoplasia (benign or malignant)

• Pregnancy
• Lactation (relative - estrogen inhibits prolactin/milk production; use progestin-only instead)
• Acute phase mononucleosis
• Impaired liver function / active liver disease
• Major surgery planned within 4 weeks (thromboembolism risk)
• Major lower extremity injury or immobilization
• Previous cholestasis during pregnancy
• Undiagnosed abnormal vaginal bleeding
• Migraine headaches (relative contraindication)
• Gallbladder disease (relative)

3. Side Effects

Estrogen Excess Effects

Progestin Excess Effects

Androgen (from 19-norprogestins) Excess Effects

• Acne, hirsutism, oily skin/scalp (most common)
• Cholestatic jaundice, edema, increased libido, rash

Cardiovascular Effects (detailed)

• Venous thromboembolism: 28% relative risk increase even with low-dose pills; absolute risk is low in healthy non-smokers, but rises sharply with smoking or other risk factors
• Hypertension: early high-dose pills caused HTN in 4-5% of normotensives; much lower with modern low-dose formulations
• Lipids: estrogen increases HDL and decreases LDL (favorable); progestins have the opposite effect. Low-dose modern COCs generally don't produce clinically unfavorable lipid profiles, though slight triglyceride increases can occur
• MI/Stroke: no significant increase in nonsmokers without other risk factors at low-dose; risk is significantly increased with smoking

Cancer Risk

Metabolic/Endocrine Effects

• Impaired glucose tolerance (less so with modern low-dose pills)
• Increased hepatic synthesis of binding proteins (affects thyroid, glucocorticoid, sex hormone level measurements)
• Dose-dependent increase in procoagulant serum factors (offset by increased fibrinolysis in non-smokers; this compensation is diminished in smokers)
• Increased gallbladder disease risk (weak effect, mainly in current/long-term users)

Miscellaneous

• Nausea and vomiting (first 1-3 months, usually resolves)
• Breakthrough bleeding (if occurs during days 1-9 = estrogen deficiency; days 10-21 = progestin deficiency)
• Headache, mild edema
• Absence of withdrawal bleeding (can cause confusion about pregnancy)

4. Progestin-Only Pill (Mini-pill) - Specific Side Effects

• Irregular spotting/breakthrough bleeding (most common reason for discontinuation)
• No increase in thromboembolic events (estrogen-related mechanism)
• Acne (androgenic activity of norethindrone-containing pills)
• Does not suppress lactation (safe in breastfeeding)
• Contraindicated: undiagnosed vaginal bleeding, benign/malignant liver disease, known/suspected breast cancer

5. Practical Notes

• A 3-month trial is recommended before judging OCP tolerability - most early side effects (nausea, breast tenderness) resolve
• Initial selection should account for BMI (obese women may need higher doses), acne, depression tendency, and weight gain history
• Pills with lower androgen content are preferred if acne/hirsutism is a concern
• Elective surgery: consider stopping OCPs 4 weeks prior to reduce post-operative thromboembolism risk
• Only ~16% of women cannot take OCPs for medical reasons

OCPs in India - Brands, Doses, Government Programs & Context

1. Government of India (GoI) OCPs

GoI-Supplied Pills

Centchroman (Chhaya) is unique - it is a non-hormonal, non-steroidal SERM (selective estrogen receptor modulator) developed in India (CDRI, Lucknow). Dose: 30 mg twice weekly for 3 months, then once weekly. It has no estrogen-related side effects (no DVT, no BP change).

2. Commercial Brands Available in India

Combined OCP (EE + Progestin)

3. Emergency Contraception in India

1. Levonorgestrel 0.75 mg (e.g., i-Pill, Unwanted-72): 1 tablet within 72 hrs + 2nd tablet 12 hrs later - most commonly used in India
2. Yuzpe regimen using standard OCPs:
   • 2 pills of 50 mcg EE OCP within 72 hrs + same dose after 12 hrs, OR
   • 4 pills of 30-35 mcg EE OCP within 72 hrs + 4 pills after 12 hrs
3. Mifepristone 10 mg once within 72 hrs (approved in India)
4. Copper IUD insertion within 5 days

4. Newer Additions to National Programme

• Chhaya (Centchroman) - oral non-hormonal weekly pill, free at public facilities
• Antara Programme - injectable MPA (Depot medroxyprogesterone acetate) 150 mg every 3 months at public health facilities
• These were added to increase "contraceptive choice" beyond just Mala-N/D

5. Who Distributes OCPs in India

6. Key Risk Factors, Doses & Side Effects - India-Relevant Points

• Smoking + OCP remains a key risk - women >35 years who smoke must not use combined OCPs
• Obese women (increasingly common) may need higher EE doses for efficacy
• Postpartum women breastfeeding should use progestin-only or Chhaya/centchroman (no estrogen to suppress lactation)
• PCOS/acne in women - drospirenone-containing pills (Yasmin, Crisanta, Dronis) are preferred in India for their anti-androgenic benefit
• Missed pill: Take as soon as remembered; take next day's pill at usual time. First pill strictly on Day 5 of menstrual cycle for first-time users