Adverse Event Reporting

Types of FDA adverse events 

The FDA classifies adverse events not by type but rather by seriousness. This is because the FDA is more concerned with events that could have serious consequences. However, any adverse event, regardless of seriousness, can be reported to the FDA through the MedWatch program.

Some examples of adverse events include

• Death: Any adverse event that results in the death of the patient.
• Life-threatening: Any adverse event where the patient was at risk of death at the time of the event.
• Hospitalization: Any adverse event that results in initial or prolonged hospitalization of the patient
• Disability: Any adverse event that causes persistent or significant disability or incapacity. This includes long-term impairments that affect a person's ability to function normally.
• Congenital Anomaly/Birth Defect: Any adverse event that results in a congenital anomaly or birth defect in a baby exposed to the product.
• Required Intervention to Prevent Permanent Impairment or Damage: This applies to medical devices. It refers to any adverse event that requires medical or surgical intervention to prevent one of the other serious outcomes listed above.

Examples of specific adverse events that could be considered serious include:

• Severe allergic reactions to a drug
• Bleeding problems caused by medication
• Device malfunctions that cause injury
• Foodborne illnesses
• Complications from cosmetic procedures

Reporting adverse events to the FDA 

The FDA doesn't directly report adverse events. Instead, they maintain a MedWatch program for voluntary reporting of adverse events by patients, healthcare professionals, and consumers. Here's how MedWatch works:

• Reporting the Event: Anyone can report an adverse event to MedWatch through various methods:
• Online Form: The most convenient option is the MedWatch Online Voluntary Reporting Form: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
• Phone: Call 1-800-FDA-1088 to report the event verbally.
• Fax or Mail: While less common, a report can also be submitted by fax or mail using a specific form (FDA 3500).
• Minimum Information Required: For the FDA to consider the report, provide the following basic information:
• Identifiable Patient: Some information about the person who experienced the event (though privacy is protected).
• Identifiable Reporter: Your information as the person submitting the report.
• Suspect Product: The FDA-regulated product assumed to cause the issue (drug, medical device, etc.).
• Adverse Event: A description of the negative health effects experienced.
• Additional Information: While not mandatory, providing more details can be helpful:
• Medical History: Any relevant medical history of the patient.
• Date and Time of Event: When the adverse event occurred.
• Severity of Event: How severe the negative health effect was.
• FDA Analysis: The FDA collects and analyzes these reports to identify potential safety concerns with FDA-regulated products. Based on this data, they may take further actions, such as issuing warnings or requiring product changes.

Adverse events must be reported to the FDA through the MedWatch program. This is essential for monitoring the safety of medical products and interventions and facilitating appropriate regulatory actions to protect public health.

Minimum criteria to report an adverse event

The FDA requires reporting of certain adverse events, but the minimum criteria are relatively simple:

• Identifiable Patient: Some information about the person who experienced the event is needed, though it may not be a full name or address to protect privacy.
• Identifiable Reporter: The person submitting the report must be identified as a healthcare professional or a patient.
• Suspected Product: The report should specify the FDA-regulated product suspected of causing the adverse event. This could be a drug, medical device, cosmetic, food, or electronic product.
• Adverse Event: A description of the adverse health effects experienced by the patient needs to be provided.

Example of an adverse event

An adverse event is an undesirable or unexpected occurrence that happens during or after using a medical product or intervention but is not necessarily caused by it. These events may range from mild to severe and can occur in various healthcare settings, including hospitals, clinics, or even clinical trials.

An example of an adverse event could be an Adverse Drug Reaction (ADR) where a patient experiences nausea, dizziness, and vomiting after taking a prescribed medication. These symptoms are not the intended effects of the drug but are instead adverse reactions that can occur as a result of the medication's use. Adverse events are not limited to pharmaceuticals; they can also occur in medical devices, surgical procedures, vaccinations, or any other healthcare intervention. Additionally, adverse events can include infections acquired during a hospital stay, complications from surgery, or unexpected side effects from medical treatments.