Should a baseline pregnancy test and reliable contraception be required before initiating bupropion and topiramate in women of child‑bearing potential?

Pregnancy Testing and Contraception Requirements Before Starting Bupropion and Topiramate

No, pregnancy testing and mandatory contraception are not required before starting bupropion or topiramate in routine clinical practice, though both medications carry teratogenic risks that warrant careful counseling and strong recommendations for reliable contraception in sexually active women of childbearing potential.

Critical Context: These Are Not FDA-Mandated REMS Programs

Unlike medications with formal Risk Evaluation and Mitigation Strategies (REMS) programs—such as mycophenolate products, which require documented negative pregnancy tests within 1 week of initiation and mandatory contraception 1—neither bupropion nor topiramate carries such stringent regulatory requirements for routine psychiatric or neurologic use.

Evidence-Based Approach by Medication

Topiramate: Higher Teratogenic Risk

Topiramate poses significant teratogenic risk and warrants the most cautious approach:

• Topiramate is associated with increased risk of orofacial clefts and other congenital malformations when used in the first trimester 1
• While not legally mandatory, obtaining a baseline pregnancy test and ensuring reliable contraception before initiating topiramate represents best practice in sexually active women of childbearing age
• The phentermine/topiramate combination product studied in hypertensive patients included women of childbearing age, though specific pregnancy testing protocols were not detailed in the efficacy data 2
• Women should be counseled that topiramate should be discontinued if pregnancy is planned or discovered 1

Bupropion: Lower but Present Risk

Bupropion carries less well-defined teratogenic risk:

• Bupropion has been studied as adjunctive therapy in bipolar depression without specific pregnancy-related contraindications noted 3, 4
• Sexually active women of childbearing age should be counseled to use reliable contraception when taking bupropion, consistent with general principles for potentially teratogenic medications 1
• A baseline pregnancy test is reasonable but not mandatory in routine practice

Practical Clinical Algorithm

For sexually active women of childbearing age (post-menarche through menopause):

1. Document menstrual and sexual history to assess pregnancy risk
2. Obtain urine pregnancy test before initiating either medication (Class C for contraception guidelines, but prudent for teratogenic drugs) 5, 6, 7
3. Counsel explicitly about teratogenic risks and the need for reliable contraception throughout treatment 1
4. Document the contraception discussion in the medical record, including the patient's contraceptive plan
5. Do not delay treatment while arranging contraception if pregnancy test is negative and patient commits to contraceptive use 7

What Is NOT Required

Based on contraception initiation guidelines, the following are not necessary before starting these medications:

• Formal contraceptive prescription or placement (though strongly recommended)
• Pelvic examination 7
• Cervical cytology 7
• STI screening (unless clinically indicated) 7
• Lipid panels, liver enzymes, or other laboratory tests 7

Key Distinctions from True REMS Programs

The mycophenolate model (which DOES require mandatory testing) includes:

• Documented negative pregnancy test within 1 week of starting 1
• Mandatory use of adequate contraception 1
• FDA Risk Evaluation and Mitigation Strategies enforcement 1

Bupropion and topiramate do not have these formal requirements, but the clinical principles remain sound.

Common Pitfalls to Avoid

• Do not assume all women are using contraception: Explicitly ask and document 1
• Do not rely on patient-reported "impossibility" of pregnancy: Pregnancy testing should be offered to all post-menarchal women through age 50-55 years 6
• Remember that urine pregnancy tests may be negative in very early pregnancy (within days of conception) and may require repeat testing if clinical suspicion exists 6
• Do not confuse "best practice" with "legal requirement": While pregnancy testing and contraception counseling are medically appropriate, they are not FDA-mandated barriers to prescribing these medications

Special Consideration: Combination Therapy

When prescribing bupropion and topiramate together (as in your question), the topiramate risk profile should guide your approach, making pregnancy testing and contraception counseling even more important given the documented teratogenic potential.