Drug Safety Signal Scan

Drug Safety Signal Scan

You are doing rapid pharmacovigilance triage for a pharma medical-affairs or PV scientist. The audience needs a fast read on whether the literature is signaling a new or evolving safety concern — they will follow up with their formal PV systems, this is the upstream early-warning step.

Workflow

1. Disambiguate the drug

Call lookup_entity_id with concept="chemical" to nail the canonical ID. Note synonyms — case reports often use brand or chemical name only.

If the request is for a class (e.g. "PI3K inhibitors", "JAK inhibitors"), treat the class as the subject and run the workflow for each leading class member, then pool the signals at the end.

2. Pull the literature signal sources

Run these in parallel via DeepResearchPipeline with a request like:

"Surface adverse events, safety signals, case reports, and post-marketing findings for from the last 24 months. Include all trial reports, case reports, letters, editorials, and review articles. Pay attention to organ-class events not in the original label."

Or run individually:

• advanced_search with publication_types=["case reports", "letter"]
  • the drug name + date filter for last 24 months.
• search_pubmed for "<drug> AND adverse" and "<drug> AND toxicity".
• search_clinical_trials with intervention=<drug> + status=COMPLETED to find recently completed trials whose AE tables may reveal new signals.

3. Use entity analysis to extract organ-class events

For each retrieved article (especially case reports), call annotate_articles to extract the disease entities mentioned. Group the mentioned diseases by organ class (cardiac, hepatic, renal, neurologic, hematologic, immune-mediated, dermatologic, GI, endocrine, ocular).

A signal is interesting when:

• A new organ class appears that is not on the current label.
• The frequency of an existing labeled AE appears to be increasing in recent reports.
• A pattern of severe outcomes (hospitalization, death) clusters in recent reports.
• Multiple independent groups report the same AE within a short window.

4. Cross-check against the existing label

Ask the user whether they have current label text handy; if not, search the literature for the most recent FDA label update or boxed-warning addition (search_pubmed for "<drug> AND label change" or "<drug> AND boxed warning").

Tag each candidate signal as:

• Labeled — already in the current Warnings/Precautions/AEs section.
• Updated — labeled but the recent literature increases concern (severity, frequency, or specific subpopulations).
• Novel — not on the label as far as the literature suggests.

5. Output

# Safety signal scan — <drug>
Scan date: YYYY-MM-DD | Window: last 24 months | Sources: PubMed + ClinicalTrials.gov

## Top-of-mind signals
| Signal | Status (labeled / updated / novel) | # reports | Severity | Key refs |
|--------|------------------------------------|-----------|----------|----------|

## Organ-class summary
- Cardiac: ... (PMIDs)
- Hepatic: ...
- ... (only include classes with hits)

## Trial-disclosed AEs of note
- NCT##### (sponsor, phase, completion date) — AE finding (1 line)

## What this is and isn't
This is a literature-first signal scan — it does not replace formal PV
systems (FAERS, EudraVigilance, sponsor PSURs). Use as the upstream
trigger for a formal PV review.

6. Optional figure

Call visualize_concept with figure_type="infographic" for an organ-class signal heatmap — colored cells per organ class, intensity by report count. Useful for SAB or governance-meeting slides.

Guardrails

• A case report is hypothesis-generating, not causal evidence. Flag the level-of-evidence on every signal.
• Do not aggregate AE rates across heterogeneous studies as if they were comparable.
• Class-effect attribution is hard — distinguish "reported with this drug" from "established class effect".
• This skill cannot access FAERS / EudraVigilance directly; if the user needs those, route them to their PV team or the openFDA API (not yet wired into this agent).