# Presentation: 326676

## Overview of Drug Safety Challenges

*Gerald J. Dal Pan, MD, MHS*
*Director*
*Division of Surveillance, Research & Communication Support*
*Office of Drug Safety*
*FDA*

## Post-marketing Drug Safety Risk Assessment:Multifaceted Challenges

- Identification of new adverse events
- Investigation of risk
- Characterization of context

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- A fundamental goal of post-marketing drug safety programs
- Must account for many different types of risk
- Must account for many potentially confounding factors
- Must account for time course of events

## Post-marketing Drug Safety Risk Assessment:What Pre-marketing Safety Data Tell Us

- Pre-clinical
- Pharmacology
- And Toxicology

- Clinical
- Pharmacology

- Clinical Safety Data
- Open-label Studies

- Clinical Safety Data
- Controlled Studies

- Pre-Marketing
- Safety Data

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Pre-marketing
-  Safety Data

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- ?

- ?

- ?

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Rare but serious adverse event

- Aplastic anemia
- Drug-induced liver injury

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Also common in the population

- Myocardial infarction

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Also a manifestation of the underlying disease

- Myocardial infarction

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- How do we separate a potential signal from the background?

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Long latency between drug exposure and event

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Drug-drug, drug-disease, drug-herbal, drug-food interactions

## Post-marketing Drug Safety Risk Assessment:Identification of New Adverse Events

- Medication Errors

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Clinical Trial

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Clinical Trial

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Clinical Trial

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Epidemiological Study - Case-Control

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Epidemiological Study - Cohort Study

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Registry

## Post-marketing Drug Safety Risk Assessment:Investigation of New Adverse Event Risk

- Registry

## Post-marketing Drug Safety Risk Assessment:Understanding Context - Duration of Exposure

## Post-marketing Drug Safety Risk Assessment:Understanding Context - Population Exposure

## Post-marketing Drug Safety Risk Assessment:Understanding Context - Population Exposure

## Post-marketing Drug Safety Risk Assessment:Understanding Context - Population Exposure

## Post-marketing Drug Safety Risk Assessment:Understanding Context

## Post-marketing Drug Safety Risk Assessment:Understanding Context: Concomitant Use

- No concomitant use

- A

- B

- High level concomitant use

- A

- B

- Low level concomitant use

- A

- B

## Post-marketing Drug Safety Risk Assessment:Summary

- Multifaceted challenges
- Many ways to explore risk
- Context can be important