Tylenol Evaluation Criteria

Manufacturers failed to adequately warn consumers and the medical community about the risks of liver side effects from Tylenol. Overdose of Acetaminophen causes serious liver injuries like;

  • Prolonged Hospitalization due to liver injury
  • Liver failure
  • Liver transplant and/or being placed on the liver transplant list
  • Death due to liver failure
  • Active Ingredient: Acetaminophen
  • Purpose: Pain reliever/fever reducer

Evaluation Focus

1. Whether the patient was prescribed Tylenol

2. Did the patient have any preexisting liver conditions, allergies or contraindications for the Tylenol drug?

3. Dosage and Intake details

  • Critical Review of Drug Prescription Details (325 mg per dosage unit)
  • Pharmacy Dispensing Details
  • Pharmacy Refill Details (Details of Pharmacy Dispensing Details are taken as Confirmatory)
  • Over the counter use

4.Did the patient develop Liver problems after Tylenol intake?

5.Liver problem diagnosis? (liver failure) – Date of diagnoses?


7.Follow-up visits for management

8. Outcome/prognosis

Specific Focus

Identify and report cases with the following scenarios:

  • No Injuries: Patient took Tylenol but did not develop any liver injury (no injury – case screening)
  • No Tylenol Intake
  • Injury present even before Tylenol intake: Patient had previous history of liver problems even before taking Tylenol.

Pre-Existing Liver Conditions – Liver cancer, Any form of liver mass, Autoimmune Hepatitis, Alcoholic cirrhosis, Primary Sclerosing Cholangitis, Wilson’s Disease, Budd-Chiari syndrome.

  • Effect of Family History and Social Habits: Family history of Liver problems, liver cancer etc.
  • Identify and report on missing medical records/pharmacy bills

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory etc. This will also help in following up and retrieving the records.


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