Safety Profile of Extended Release (650 mg) Acetaminophen Products in the United States: Non-Interventional Post-authorization Safety Study of the National Poison Data System and Food and Drug Administration Adverse Event Reporting System Databases

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, observational (non-interventional), Post-authorization Safety Study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N02BE01) paracetamol

  paracetamol

Population studied

• Short description of the study population:
  NPDS data are from adolescent and adult (age ≥12 years) patients exposed to extended release (650 mg) or immediate release (325 or 500 mg) acetaminophen products reported to a poison center between 2007 and 2016. FAERS data include US reports of adolescent and adult (age ≥12 years) patients with a primary suspect, secondary suspect, concomitant, or interacting drug of extended release (650 mg) or immediate release (325 or 500 mg) acetaminophen products reported to the FDA between 2011 and 2016. ; The NPDS patient selection criteria are:; 1. an adolescent or adult patient aged ≥12 years; 2. exposure occurred in the US; 3. exposure to extended release (650 mg solid acetaminophen) or immediate release acetaminophen (325 mg or 500 mg acetaminophen) product; The FAERS patient selection criteria are; 1. an adolescent or adult aged ≥12 years; 2. exposure occurred in the US (where reported, US reporter and event occurred location; non-foreign report); 3. primary suspect drug, secondary suspect drug, concomitant drug, or interacting drug name is extended release or immediate release acetaminophen product
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  35000

Study design details

• Main study objective:
  The objective of this study is to describe the safety profile of extended release acetaminophen in the US through evaluation of two independent surveillance data systems, the National Poison Data System (NPDS) and the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
• Data analysis plan:
  Using data from both databases, descriptive statistics will be used to characterize exposures and outcomes for extended release acetaminophen product exposures. Rates will be calculated with exact 95% Poisson confidence intervals. Rates and outcome distributions will be compared for extended release and immediate release acetaminophen product exposures.

Documents

Study results

APAP PASS CSR 01MAY2020 Approved Compressed

Extended Release Acetaminophen COMBINED Report FINAL 01May2020