Adverse Event Reporting to the FDA

November 20, 2017 By

Adverse Event Reporting to the FDA


Post-market vigilance of drug, biologic and supplement products has been steadily increasing in recent years, not only domestically but internationally as well. For example, Health Canada recently completed a Summary Safety Review (SSR) on Green Tea Extracts (GTEs), which was published on November 15, 2017. The result of the SSR is the requirement for increased safety warnings on products containing GTEs, as well as the halt of these products being marketed to children and adolescents under 18. MedWatch is the FDA’s Safety Information and Adverse Event Reporting Program. Information on this program is available online on the FDA website. As another example of ongoing vigilance, the FDA issues quarterly updates related to “Potential Signals of Serious Risks/New Safety Information”. These updates summarize information gathered through the FDA’s Adverse Event Reporting System (FAERS). The FDA completes its evaluation of each potential safety issue and issuing additional public communications as appropriate.

The MedWatch Web site is used to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure suspected to be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. Suspected counterfeit medical products can also be reported to the FDA through MedWatch. Reports submitted to MedWatch (FAERS) from healthcare professionals and consumers are voluntary. These people may also report to the products’ manufacturers. If a manufacturer receives a report from a healthcare professional or consumer, it is required to send the report to the FDA as specified by the regulations.

For other product categories that do not require FDA pre-approval before marketing, such as Dietary Supplements, reporting is done through the Safety Reporting Portal. This can be used by consumers, health care professionals and industry.

Product marketers need to be aware of their responsibilities to report adverse reactions to the FDA.

No matter what the product category is, Serious Adverse Events must be reported to the FDA.

What is a Serious Adverse Event?

An adverse event is any undesirable experience associated with the use of a medical product in a

patient. The event is considered to be serious and should be reported to FDA when the patient outcome is:

  • Death
  • Life-threatening
  • Hospitalization (initial or prolonged)
  • Disability or Permanent Damage
  • Congenital Anomaly/Birth Defect
  • Required Intervention to Prevent Permanent Impairment or Damage (Devices)
  • Other Serious (Important Medical Events) – Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical treatment to prevent one of the other outcomes. An example would be allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room.

In summary, there are two broad platforms to report adverse reactions and events.

What to Report to FDA MedWatch:

Use MedWatch to report adverse events (observed or suspected) for human medical products, including serious drug side effects, medication errors/product use errors, product quality problems, and therapeutic failures. The following product categories are reported through MedWatch:

  • Prescription or over-the-counter medicines
  • Biologics (including blood components, blood and plasma derivatives, and cellular and tissue-based products)
  • Medical devices (including in vitro diagnostic products)
  • Combination products
  • Special nutritional products (infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions)

What Not to Report to FDA MedWatch:

  • Tobacco product problems
  • Vaccines
  • Investigational (study) drugs
  • Mandatory reporting required by regulated industries (Drugs and Biologics, Devices)
  • Dietary Supplements
  • Veterinary Medicine Products

How to Report a Problem with Dietary Supplements

Instead of MedWatch, reports for Dietary Supplements should be filed through the Safety Reporting Portal. This can be used by consumers, health care professionals and industry.

For Dietary Supplements, an Adverse Event Report (AER) is only required to be reported to the FDA when it is for a “serious adverse event” associated with such dietary supplement when used in the United States. Serious AERs that take place outside the US would be considered non-reportable to the FDA.

Post-market surveillance and vigilance continues at an advanced pace across international boundaries.

dicentra can offer brand owners and marketing firm’s assistance with filing Serious Adverse Event Reports and Annual Product Summaries to relevant regulatory authorities. Please contact us if you need assistance in this area.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries.