Understanding Medication Use During Pregnancy: Safety Alerts Explained

When you’re pregnant, every pill, supplement, or over-the-counter remedy feels like a gamble. You want to feel better, but you’re terrified of hurting your baby. This isn’t just anxiety-it’s a real, systemic problem. Nearly 90% of pregnant women take at least one medication during pregnancy, and half take four or more. Yet, for most of those drugs, we simply don’t have clear, reliable data on whether they’re safe.

Why We Don’t Know Much About Medications in Pregnancy

For decades, pregnant women were left out of clinical trials. The fear of causing harm led to exclusion, not protection. The result? Only 5% to 10% of FDA-approved drugs between 2003 and 2012 had enough human data to even begin assessing risk during pregnancy. That’s not a gap-it’s a chasm.

The old system made things worse. From 1979 to 2015, the FDA used letters: A, B, C, D, X. It sounded simple, but it confused everyone. A “C” didn’t mean “moderate risk.” It meant “animal studies showed harm, but human data was lacking.” Many women stopped essential medications because they thought “C” meant dangerous. Studies show that confusion led to an 18% rise in unnecessary medication discontinuation.

In 2015, the FDA scrapped the letter system. In its place came the Pregnancy and Lactation Labeling Rule (PLLR). Now, drug labels must include detailed narrative sections: what we know about pregnancy, breastfeeding, and fertility. But here’s the catch: many labels still say “insufficient data.” That’s not helpful. It’s a cop-out.

How Safety Alerts Actually Work

Safety alerts aren’t just warnings. They’re responses to real signals. The FDA and EMA track reports from doctors, patients, and pharmacies. When a pattern emerges-like a cluster of birth defects linked to a specific drug-a safety alert is issued.

Take valproate, used for epilepsy and bipolar disorder. Before the alert, the risk of neural tube defects was around 0.1%. After exposure, it jumped to 1-2%. That’s a 10- to 20-fold increase. In 2022, the FDA issued a Class I alert-the most serious-for valproate, urging doctors to avoid it in pregnancy unless absolutely necessary.

Other high-risk drugs include isotretinoin (Accutane), which causes severe birth defects in 20-35% of exposed pregnancies, and thalidomide or lenalidomide, which can cause limb malformations. These drugs now come with strict pregnancy prevention programs: mandatory contraception, regular pregnancy tests, and signed consent forms.

But here’s the problem: these alerts rely on data that’s often years late. Pregnancy exposure registries collect information from women who take certain drugs while pregnant. The FDA has 38 active registries. But they capture less than 1% of all pregnancy medication exposures. Dr. Christina Chambers’ research at UC San Diego found that safety alerts are delayed by an average of 7.2 years because the data comes in too slowly.

U.S. vs. Europe: Different Rules, Same Gaps

The U.S. and Europe handle this differently, but neither has solved the core issue.

The FDA’s PLLR requires detailed labeling, but only 32% of those labels include actual numbers-like “risk of heart defect: 1 in 100.” Most just say “possible risk.” That’s not guidance. It’s guesswork.

The EMA takes a more active approach. For high-risk drugs like lenalidomide, they require mandatory contraception for six months after stopping treatment. They also demand that drug companies monitor pregnancy exposure in real time. But a 2022 European audit found that 41% of companies didn’t even meet the minimum requirements.

Both systems are better than the old letter system, but both still rely on passive reporting. If a woman doesn’t tell her doctor she took a drug, or if her pharmacy doesn’t report it, the system doesn’t see it.

What You Can Do Right Now

You don’t have to wait for perfect data. Here’s what works:

• Get a medication review at your first prenatal visit. ACOG recommends listing every pill, supplement, and herb-even CBD gummies or herbal teas. This takes about 22 minutes, but it cuts inappropriate discontinuation by 45%.
• Don’t stop essential meds without talking to your doctor. Untreated depression, asthma, high blood pressure, or seizures can be more dangerous to you and your baby than the medication. A 2021 survey found that 29% of women with chronic conditions stopped their meds when pregnant-and 63% of those cases were later advised to restart them.
• Use trusted sources. The FDA’s “Medicine and Pregnancy” page and Mass General’s Pregnancy Medication Safety Hotline have received 4.3/5 ratings from users. Avoid random Reddit threads or unverified apps.
• Take folic acid. 800 mcg daily, starting before conception and continuing through week 12, reduces neural tube defects by up to 70%. This is one of the few clear, evidence-based wins in pregnancy medication safety.

The Human Cost of Uncertainty

On Reddit’s r/Bump community, 68% of pregnancy medication posts in 2022 were about fear and confusion. One woman wrote: “My doctor told me to stop my antidepressant immediately. Now I’m in crisis. Why isn’t there clearer guidance?”

She wasn’t alone. Drugs.com saw 1.8 million pregnancy medication queries in 2022. In 42% of negative reviews, users complained about “contradictory information.” One woman stopped her blood pressure medication because a blog said it was risky. She ended up in the hospital with preeclampsia.

The truth? Most medications used in pregnancy are not proven dangerous-they’re just not proven safe. That’s not the same thing.

What’s Changing-and What’s Still Broken

There’s hope. The NIH launched PREGNET in January 2024: a $25 million project connecting 45 medical centers to track 100,000 pregnancies in real time. IBM Watson Health predicts AI will predict medication risks with 70% accuracy by 2027 by analyzing millions of de-identified records.

But money is tight. The March of Dimes estimates a $312 million annual funding gap through 2030. Without investment, these systems will stall. Right now, only 22% of drug companies maintain the pregnancy registries they’re required to run.

Meanwhile, 70% of obstetricians say they frequently encounter medications with no reliable safety data. That’s not a failure of patients. It’s a failure of infrastructure.

Bottom Line: Be Informed, Not Afraid

You don’t need to be a scientist to make smart choices. You need to know:

• Some medications are dangerous-like isotretinoin, valproate, and thalidomide. Avoid them unless there’s no alternative.
• Many medications are safe-or safer than the illness they treat. Depression, asthma, thyroid disorders, and diabetes all carry risks if left unmanaged.
• There is no universal “safe” list. What’s right for one person may not be right for another.
• Always talk to your provider before stopping or starting anything-even something you think is harmless.

The goal isn’t to avoid all medication. It’s to use the right one, at the right time, with the right support. You’re not alone in this. And you don’t have to guess your way through it.

Next Steps: What to Do Today

• Make a list of every medication, supplement, and herb you’re taking-prescription, over-the-counter, and herbal.
• Call your OB-GYN or midwife and ask for a medication review at your next visit.
• If you’re unsure about a drug, visit the FDA’s Medicine and Pregnancy page or call Mass General’s Pregnancy Medication Safety Hotline.
• Start taking 800 mcg of folic acid daily if you aren’t already.
• Don’t rely on Google. Use trusted medical resources.

The system isn’t perfect. But you have more power than you think. With the right information and support, you can protect your health-and your baby’s-without living in fear.