“Missing information” is more than just a technical term in pharmacovigilance. It represents a gap between what we know and what we still need to learn to ensure patient safety. These gaps often appear in risk management plans (RMPs), especially concerning populations not typically included in clinical trials, such as pregnant women.

When a new medicine is approved, its safety profile is based on limited data. Clinical trials are controlled, selective, and often exclude vulnerable populations. This means that specific real-world scenarios – like drug use during pregnancy – remain unstudied at the time of approval.

As a result, drug labels often include statements such as “not recommended during pregnancy due to lack of data” or “no adequate studies available in pregnant women.” This “missing information” becomes a safety concern that demands attention through post-marketing pharmacovigilance.

What Is “Missing Information” in Risk Management Plans?

The European Medicines Agency defines missing information in RMPs as gaps in knowledge about a medicinal product’s safety profile related to use in certain populations or under specific conditions.

Some common examples include:

• Drug use during pregnancy or breastfeeding
• Use in children or the elderly
• Patients with comorbidities or organ dysfunction
• Long-term safety data not yet available

Pharmacovigilance systems must actively monitor and assess emerging risks when healthcare providers use medicine in the real world for these populations.

This is where medical literature monitoring becomes crucial. Clinical trials can’t cover every possibility – but published case reports, observational studies, and real-world data can provide critical insights.

A Case That Highlights the Issue: Inclisiran and Pregnancy

In 2025, a published case report described a woman who became pregnant three months after receiving an injection of inclisiran, a novel cholesterol-lowering drug.

Inclisiran is a small interfering RNA (siRNA) therapeutic that reduces LDL cholesterol by targeting PCSK9 synthesis. Like many innovative therapies, it is a relatively new treatment and lacks sufficient safety data in pregnant women.

In the reported case, the pregnancy progressed without complications. The baby was born healthy, and no adverse effects were noted during follow-up.

This is encouraging, but it’s still just a single case and doesn’t resolve the uncertainty.

That’s why this case is included in the RMP as part of the missing information category – use in pregnancy. It reminds us of the importance of collecting and assessing every piece of real-world data to close those knowledge gaps.

How Was This Case Found?

This case wasn’t part of a clinical trial or spontaneously reported to a regulatory authority. It was published in the medical literature and detected thanks to medical literature monitoring.

This type of proactive monitoring allows pharmacovigilance teams to:

• Identify rare or unusual safety cases
• Detect safety concerns not covered in clinical trials
• Support risk minimization and regulatory decisions
• Fill in missing information in RMPs over time

Why Medical Literature Monitoring Is Essential for Missing Information

Medical literature is a key pillar of pharmacovigilance. Case reports, case series, observational studies, and real-world analyses offer valuable information that complements spontaneous reporting systems and regulatory databases.

In particular, literature monitoring:

• Fills data gaps that exist in product safety profiles
• Captures safety signals early, even in individual cases
• Supports periodic safety update reports (PSURs) and regulatory assessments
• Helps address specific safety concerns, like use in pregnancy or lactation

In the context of missing information, literature monitoring is not just helpful – it’s necessary.

Looking Forward: From One Case to Many

The story of inclisiran and pregnancy is just one example. Similar cases are likely hidden in journals, waiting to be discovered and analyzed.

As more new drugs enter the market and are used in off-label or unstudied populations, the role of medical literature monitoring will only grow.

It’s not enough to wait for spontaneous reports. Pharmacovigilance must be proactive. Tools like DrugCard make it possible to identify key findings early, track evolving patterns, and ensure that missing information doesn’t stay missing for long.

Conclusion

For healthcare providers, “missing information” means uncertainty. Should a pregnant patient continue a treatment? Should a new therapy be avoided altogether? What if there’s no alternative?

The inclisiran pregnancy case reminds us that every real-world patient matters. Each case report is more than a story – it’s a potential signal, a missing puzzle piece, a clue in the larger picture of drug safety.

In a world where drug development moves fast, and real-life use is often ahead of the data, pharmacovigilance has to catch up – quickly and continuously.

Medical literature monitoring is one way we do that. And it’s more vital than ever.