Kelsey
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Kelsey reads the safety record of any drug or device, and alerts you when it changes.

Ask in plain English. Kelsey connects 21 million FDA reports with label history, FDA reviews, studies, foreign regulators and court rulings, and cites the passage behind every statement.

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Kelsey
Product illustration. Question: What did published studies report about eye risk with redacted before the label warned of it? Answer: A six-patient case series published in 2018 reported pigmentary maculopathy in patients with long-term redacted exposure and called for further investigation of causality [1]. FDA’s review describes the manufacturer’s June 2019 labeling submission [2]. FDA approved the revised warning in June 2020 [3]. Sources: [1] Pearce et al., Ophthalmology, 2018, published; [2] FDA review describing the manufacturer’s June 2019 labeling submission, 24 Jun 2019, submitted; [3] redacted label, Warnings, 16 Jun 2020, approved. Source 3 is open: redacted label · Warnings · approved 16 June 2020. Highlighted passage: Summary of the June 2020 label: retinal pigmentary changes have been reported with long-term use of the drug, redacted.

Kelsey has masked names for presentation; the masking is not part of the cited originals. Animation timing does not represent measured product speed.

What Kelsey finds in the record

  1. 01The gap

    Evidence was public two years before the label warned.

    A study described the eye damage in May 2018. FDA approved the warning in June 2020.

  2. 02Selected regulatory milestones

    A European committee’s document is dated 27 June 2019; FDA approved the US labeling supplement on 16 June 2020.

    These are different procedural milestones, shown on one dated line.

    Regulators

    : selected regulatory milestones

    1. Europe27 Jun 2019 decidedEurope’s committee backs a warningCHMP scientific conclusions
    2. FDA16 Jun 2020 approvedFDA approves the US warning label, Warnings

    “In literature, pigmentary maculopathy has been reported rarely, with , especially after long-term use.”

    European regulator, scientific conclusions · 27 June 2019

    The cited CHMP document is dated 27 June 2019; FDA approved the US labeling supplement on 16 June 2020. These are different procedural milestones.

    Product illustration. The cited CHMP document is dated 27 June 2019; FDA approved the US labeling supplement on 16 June 2020. These are different procedural milestones.

    Kelsey has masked names for presentation; the masking is not part of the cited originals. Animation timing does not represent measured product speed.

  3. 03The corrected premise

    Asked about the generic maker’s argument, it shows the motion came from the brand maker.

    The answer corrects the question, then cites the decision and the Supreme Court case on generic labels.

    Kelsey
    Product illustration. Question: What did the generic maker argue on preemption in the redacted case? Answer: The preemption motion in the 2019 redacted decision came from the brand maker, not a generic maker [1]. For generic makers, a 2011 Supreme Court decision holds that federal law requires their label to match the brand’s [2]. Sources: [1] A 2019 federal district court decision, decided 2019; [2] A 2011 Supreme Court decision on generic labels, decided 2011. Source 2 is open: A 2011 Supreme Court decision on generic labels. Highlighted holding, paraphrased: federal law requires a generic drug's label to be the same as the brand-name label, so a generic maker cannot change its label on its own to meet a state-law duty to warn; state claims that would require it are preempted.

    Kelsey has masked names for presentation; the masking is not part of the cited originals. Animation timing does not represent measured product speed.

  4. 04Reporting comparisons

    Counts with and without lawyer-filed reports and likely duplicates.

    You see how the numbers move when those reports are left out.

    Signal

    Reported more often than other drugs?

    · gastroparesis

    All reports, including those filed by lawyers.

    Bar lengths are illustrative and do not represent results for a particular drug. Adverse-event reports do not establish incidence or causation.

    Product illustration, schematic with no real figures: a bar for one drug’s reports mentioning gastroparesis against all other drugs, with and without lawyer-filed reports.

    Kelsey has masked names for presentation; the masking is not part of the cited originals. Animation timing does not represent measured product speed.

  5. 05Emerging evidence

    New evidence about a risk, as it appears.

    A watch list on a drug, a class or a portfolio flags each new study, foreign regulator warning, FDA safety communication and label change, dated and linked to its source.

    Alert

    Watch list

    Added since the previous check

    • New studyJournalpublished
    • Foreign regulator warningRegulator websitedecided
    • New label versionFDA labelapproved

    Each check compares with the one before and links every item to its source.

    Product illustration, schematic: a watch list lists three items added since the previous check, a new study, a foreign regulator warning and a new label version, each linked to its source.

    Kelsey has masked names for presentation; the masking is not part of the cited originals. Animation timing does not represent measured product speed.

Every answer checks out against the public record

Sources

  • FDA adverse-event and device reports
  • Label versions and FDA reviews
  • Studies, trials and regulators abroad
  • Court rulings, regulations and statutes

Resources

Connected

  • By drug, ingredient and manufacturer
  • On one dated timeline
  • Likely duplicate reports matched
  • Lawyer-filed reports kept apart

Features

Checkable

  • Each statement linked to its passage
  • Each date marked by type
  • Calculations an expert can rerun
  • When nothing is found, what was searched

How Kelsey answers

21M+
FDA adverse-event reports
1M+
documents read
31+
sources, continuously updated

Questions Kelsey answers

  • Label history

    “Show the label history of for pigmentary maculopathy: when did the label first name it, and in which section?”

    What comes back: FDA approved the warning on 16 June 2020. The 8 earlier label versions did not mention it.

  • FDA record

    “What did FDA’s reviewers say about this risk at approval, and did the company later propose a warning FDA declined?”

    What comes back: The reviewers’ passages with page numbers, the company’s submissions and FDA’s response, each dated.

  • Signal

    “Is reported with gastroparesis more often than other drugs? Show how it developed over time.”

    What comes back: The quarter-by-quarter comparison with other drugs, and a note that these reports do not show the drug caused the event.

  • Literature

    “List the published studies on and tendon rupture.”

    What comes back: The publications found by the documented search, with the first publication date and the counts by study design.

  • Regulators abroad

    “Did regulators abroad act on and bladder cancer before the US label changed?”

    What comes back: Each regulator’s action with its date, quoted and linked, and the regulators searched.

  • Devices

    “Surgical mesh migration: what device recalls and adverse event signals exist?”

    What comes back: Matching recall records by date and class, each with a link to the FDA record.

  • Law

    “Which Rule 702 rulings accepted or rejected statistics drawn from FDA’s adverse-event reports?”

    What comes back: The rulings, with court, date and the passage on the method, for both outcomes.

  • Watch list

    “Which GLP-1 drugs gained new evidence of pancreatitis in the last 90 days, and did any foreign regulator act first?”

    What comes back: Each drug’s new dated items, with foreign regulators’ actions and their dates.

  • Expert

    “Which terms make up ‘eye damage’, and where does each number come from?”

    What comes back: The list of terms and the data behind each calculated figure.

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