Medicines in pregnancy & breastfeeding — safety | mojApteczka

The leaflet is eight pages long. The pregnancy-and-breastfeeding section opens with "insufficient clinical data." The doctor prescribes, the pharmacist says nothing, the internet panics. You have three medicines at home and one question: which of them can I give to my breastfeeding wife tonight?

Since version 1.8.7, mojApteczka shows a compact pregnancy- and breastfeeding-safety badge on every medicine card — with the source of the assessment explicitly named (EMA, OpenFDA, FDA monograph). It does not replace a conversation with a doctor, but it eliminates the moment when you are holding an Augmentin box and cannot remember what section 4.6 of the SmPC said.

What you see on the medicine card

For each medicine in your cabinet, the card displays two badges:

• "Pregnancy" — with a safety-level assessment (clear, e.g. "Allowed in certain trimesters"; caution — "Consult your doctor"; contraindicated — "Not recommended"),
• "Breastfeeding" — analogous, with an assessment for lactation.

Below each badge sits the source attribution: "EMA" when the assessment comes from the European Medicines Agency (ePAR section 4.6), "OpenFDA" / "FDA" when data comes from FDA monographs, "URPL" when mojApteczka extracts the assessment from the Polish SmPC. This is a licensing requirement of our data providers — your information is always backed by a specific named source.

Where the assessments come from

mojApteczka combines three public regulatory data sources:

• EMA ePAR — section 4.6 of European Summaries of Product Characteristics (centrally authorised by EMEA),
• OpenFDA / FDA Drug Monographs — full FDA monographs, including Pregnancy / Lactation sections,
• URPL SmPC — the Polish Office for Registration of Medicinal Products (URPL).

We extract the safety paragraphs, classify them into three levels (green / amber / red), and surface the result directly on the medicine card. You can read the full source text via offline SPC docs — that gives you the full 4.6 paragraphs, not just the assessment.

Reliable database refresh

Version 1.8.6 introduced granular fail isolation for syncing: every ATC group is fetched independently; a failure in one does not block the others. So when URPL is briefly unreachable, the pediatrics group keeps updating, and the "Antibiotics" section heals on its own once the source returns. Previously (1.8.5) a single transient network failure could leave some medicines (e.g. Ibum Forte) without pregnancy/breastfeeding data.

In practice: if you see a medicine without a Pregnancy/Breastfeeding section, you can force a refresh via Settings → Medicine documentation cache → Refresh now. The medicine card updates the moment its ATC group is fetched — you don't wait for the full database sync.

Why the EMA source is explicitly named

EMA shares data publicly but its licence requires the source to be named on every consumption. Versions 1.8.5 and earlier classified some EMA assessments as "no data" in certain cases (the "EMA" label was silently dropped in the old schema). Version 1.8.7 (ADR-095) finished the attribution work: every ePAR-derived assessment now reads "EMA — European Medicines Agency" on the medicine card, in the docs sheet, and in VoiceOver narration.

Version 1.8.7 also shipped a device-cache migration: 307 products with EMA data (Avastin / Ocrevus class) stored before the attribution change received correct sourcing without waiting for a server-side schema bump.

Clarity of safety information

Version 1.8.7 added a compact safety summary: the key sentence sits at the top of the card (e.g. "Not recommended in the first trimester"), the full source text is one tap away. The pregnancy/lactation badges are grouped together in a single "badge group" instead of being scattered across the medicine card.

In a typical 3 a.m. paediatric scenario: 4 seconds instead of "read the entire leaflet."

How it connects with other features

The pregnancy/breastfeeding safety data is a layer on top of existing features:

• Offline SPC docs — full 4.6 (Pregnancy and breastfeeding) sections from SmPC and ePAR, ~8 000 medicines offline,
• Pediatric classification — for children; pregnancy/breastfeeding is a separate dimension,
• Medicine search — look up safety data for a medicine before adding it to your cabinet,
• Leaflets — the full leaflet, where the pregnancy section is usually a long paragraph,
• Interactions — an independent dimension; pregnancy + interactions are two separate checks.

Availability

Pregnancy and breastfeeding safety badges are available in the mojApteczka iOS app (since version 1.8.3, with the final source attribution from 1.8.7). The Android version is planned. The web version also shows the badges within a configured scope.

Note — this is not medical advice. The pregnancy / breastfeeding badges in mojApteczka are a summary of publicly available regulatory information. They do not replace consultation with a doctor, a pharmacist, or a family-medicine specialist. Full therapeutic decisions, especially around pregnancy and lactation, must always be made with the doctor managing the pregnancy or a pharmacist — regulatory information is a framing, not a complete individual risk assessment.

Pregnancy and breastfeeding safety on the medicine card turns "I have to read eight pages of a leaflet at 3 a.m." into "four seconds, a colour-coded badge, an explicit EMA/FDA source, the full text one tap away." Reliable refresh and explicit source attribution close the gap that existed in 1.8.5.