Why Are Some Countries Still Prescribing High-Risk Dermatological Drugs to Women of Reproductive Age

A Global Look at Policy Gaps, Prescriber Practices, and the Ongoing Risk to Maternal-Fetal Health
In dermatology, certain medications are known for their transformative outcomes. They can clear severe nodulocystic acne, alleviate chronic psoriasis, and help manage complex inflammatory skin disorders. But along with their therapeutic power, some of these drugs carry a darker consequence—teratogenicity: the potential to cause serious birth defects if used during pregnancy.

Despite decades of clinical warnings, pharmacovigilance programs, and thousands of published reports, many countries continue to prescribe these high-risk drugs to women of reproductive age without sufficient safeguards.

This isn't merely a clinical oversight—it represents a global public health blind spot that’s been long ignored.

So why, in the modern era of digital health records, evidence-based medicine, and increased awareness about reproductive rights, are drugs like isotretinoin, acitretin, and tazarotene still prescribed so casually in certain regions?

This article investigates the convergence of systemic weaknesses, cultural silence, medical habits, and pharmaceutical gaps that perpetuate this silent but dangerous practice.

The Teratogenic Dermatology Drugs in Question

These medications are not rare or obsolete—they’re staples in many dermatological treatment plans.

Isotretinoin (commonly known as Accutane) is one of the most effective agents for severe, treatment-resistant acne.

Acitretin is frequently used in chronic plaque psoriasis.

Tazarotene is prescribed for acne and photoaged skin.

Topical tretinoin and its retinoid cousins are routinely recommended for everything from comedonal acne to hyperpigmentation and wrinkle prevention.

The problem? These drugs are all known teratogens.

Isotretinoin carries a 20–30% risk of major congenital anomalies when taken during pregnancy, including craniofacial defects, cardiovascular abnormalities, and neural malformations.

Acitretin is stored in adipose tissue and remains teratogenic for years after cessation—making pregnancy planning extremely difficult.

Tazarotene and other topical retinoids have demonstrated fetal toxicity in animal studies and are generally contraindicated in pregnant individuals.

With such compelling data, global consistency in prevention would seem obvious. Yet that’s not what reality shows.

Disparities in Risk Management Programs Across Borders

Some countries have adopted aggressive pregnancy prevention initiatives.

In the United States, the iPLEDGE program mandates strict requirements: two reliable contraception methods, negative pregnancy tests before and during treatment, monthly reporting, and signed patient acknowledgments.

The UK’s Pregnancy Prevention Programme (PPP) requires detailed patient education, written consent, and consistent follow-up.

Most EU countries operate under similarly rigid systems with government-enforced pharmaceutical controls.

In contrast, many low- and middle-income countries (LMICs)—and even some high-income countries with fragmented private health sectors—fall far short. In these settings, reproductive safeguards are often:

Nonexistent

Loosely enforced

Missing any structured patient education

Vulnerable to regulatory loopholes in drug dispensing

Consequently, thousands of women begin using these high-risk medications:

Without understanding the teratogenic risks

Without contraceptive counseling or access

Without undergoing pregnancy screening

Without ever signing a consent form

Lack of Regulatory Enforcement: A Global Blind Spot

Even in countries where protective guidelines technically exist, enforcement is inconsistent and often ineffective. Several factors contribute to this failure:

Underfunded national drug regulatory authorities

Lack of electronic tracking systems for prescriptions

Poor coordination among dermatologists, pharmacists, and gynecologists

Corruption or informal prescribing practices, especially in cosmetic clinics

Aesthetic culture pushing “quick fixes” for skin concerns, sidelining safety discussions

In some countries, patients can obtain isotretinoin faster than they can access a contraceptive consult. This imbalance represents a structural failure in how healthcare systems prioritize reproductive safety.

OTC and Online Access: The Digital Risk Nobody Controls

One of the most alarming developments in recent years is how easily these medications can be accessed without proper supervision. Many women obtain high-risk dermatologic drugs through:

Over-the-counter sales in countries with lax regulation

Online platforms that bypass prescription requirements

Social media influencers advertising retinoid-based treatments without disclosure of pregnancy risks

Even in countries with strict protocols, patients can import isotretinoin or acitretin from international sources, effectively sidestepping all regulatory controls.

This unmonitored digital pharmacy creates a massive loophole in global drug safety efforts.

Doctor-Patient Dynamics: Silence, Assumptions, and Cultural Barriers

Physicians are often caught between cultural discomfort and time pressure. As a result, they may make dangerous assumptions like:

“She doesn’t appear sexually active”

“She’s probably using birth control”

“She’s married—she must be planning a pregnancy soon”

“I told her about risks briefly—that should be enough”

These assumptions are often paired with societal norms that discourage open conversations about sex, contraception, or pregnancy planning—especially in more conservative regions.

In such environments, physicians may avoid thorough reproductive discussions, and patients, fearing stigma or judgment, may avoid asking questions. The result is silence—and in that silence, risk thrives.

The Cosmeticization of Dangerous Drugs

Another dangerous trend is the rising use of teratogenic medications for purely aesthetic goals:

Young women receiving isotretinoin for mild or moderate acne

Retinoid creams prescribed routinely for anti-aging

Systemic retinoids offered for vague skin texture complaints in image-driven clinics

In such cases, the clinical benefit is marginal, and the risk-benefit ratio becomes heavily skewed. These medications are being used not to manage disabling dermatologic disease—but to chase unrealistic beauty standards.

This trivial use of powerful, high-risk medications places countless women at risk of avoidable fetal harm, all in the name of cosmetic enhancement.

Pharmaceutical Influence and Market Pressures

Pharmaceutical companies don’t directly promote teratogens for unsafe use, but they shape prescribing culture in subtle ways:

Describing medications as “safe when used correctly,” without emphasizing that proper use is not consistently enforced worldwide

Funding education events that focus on drug efficacy but sideline safety protocols

Pushing broader indications that blur the lines between cosmetic and medical use

Failing to support awareness campaigns in countries lacking healthcare infrastructure

In some under-regulated markets, pharmaceutical representatives may informally encourage prescribing without reinforcing contraception counseling or pregnancy testing.

This commercialization of teratogenic drugs—especially in private sectors—often happens under the radar.

Informed Consent in Name Only

In many clinics, “informed consent” is reduced to a checkbox. The reality?

Consent forms are printed in languages patients don’t fully understand

Medical jargon dominates, and time to explain is minimal

The process becomes routine and bureaucratic—not educational

Patients are rushed through paperwork and never given the space to voice concerns

Without genuine informed consent—facilitated by dialogue, supported by visual tools, and free from coercion—patients are not truly protected.

When an unplanned pregnancy occurs during therapy, the consequences are profound: emotional trauma, moral distress, and complex medicolegal outcomes.

How to Fix This: What Needs to Change

This crisis isn’t about a lack of knowledge. It’s about failing to translate that knowledge into universal, actionable safeguards.

Solutions should include:

Mandatory, standardized pregnancy prevention programs globally

Training clinicians in counseling techniques for reproductive safety

Routine integration of contraception access with dermatology care

Digital systems that flag high-risk prescriptions and require documentation

Tighter regulation of online pharmacies and over-the-counter distribution

Culturally adapted consent forms that explain risk clearly and empathetically

Media campaigns to educate women on the dangers of self-medicating with retinoids

Every stakeholder—from dermatologists and pharmacists to regulators and patients—has a role to play in creating a safer system.

Final Thoughts: We Can—and Must—Do Better

The medical community has long known the teratogenic risks of drugs like isotretinoin and acitretin. The science is irrefutable. And yet, in clinics, pharmacies, and online markets across the globe, these drugs are still dispensed like basic skincare products.

This isn’t just a medical issue. It’s an ethical one.

Physicians have the responsibility to protect, inform, and empower. Regulatory bodies have the responsibility to enforce safeguards. And society as a whole has the responsibility to prioritize maternal-fetal health over aesthetics, convenience, or profit.

Because a prescription for acne should never end in a lifelong birth defect.

Until safety becomes as non-negotiable as efficacy, we are failing the very people we are supposed to help.