The FDA Safety Information and Adverse Event Reporting Program
"Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products."
Consumers and the Food and Drug Administration (FDA)
Consumers play an important public health role by reporting to the FDA any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product.
What is MedWatch?
MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.
FDA-regulated products include:
***** human drugs (both prescription and over-the-counter)
***** medical devices (ex. contact lenses, glucose tests, pacemakers, and medical x-rays)
***** blood products, human cell and tissue products, and other biologics (except vaccines)
***** special nutritional products (dietary supplements, infant formulas, and medical foods such as nutritional supplements used under medical supervision)
What types of problems should you report to MedWatch?
MedWatch is for reporting four types of problems with human health care products. Examples of each type of problem are shown here:
1. Serious adverse event
* life-threatening situation
* requires admission to hospital or longer-than-expected hospital stay
* permanent disability
* birth defect, miscarriage, stillbirth, or birth with serious disease
* requires medical care to prevent permanent damage
2. Product quality problem
* suspected counterfeit product
* potentially contaminated product indicated by suspicious odor or unusual color
* inaccurate or unreadable product labeling
3. Product use error
* mixing up products with similar drug names or packaging
* taking wrong dose of a drug because of confusing dosing instructions on label
4. Problem with different manufacturer of same medicine
* not getting same results from a generic drug as a brand name drug, or from another generic
What is an adverse drug reaction?
An adverse drug reaction, also called a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.
Why should you report problems to the FDA?
In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these serious events. FDA uses the data to maintain the safety surveillance of products. Your report may be the critical action that prompts a modification in the use or design of a product, improves its safety profile and leads to increased patient safety.
“Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval,” says Norman Marks, M.D., Medical Director of FDA’s MedWatch Program. “Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death.”
To locate information on the known side-effects of marketed drugs, including strengthened warnings undergoing FDA review or minor editorial changes, visit DailyMed which is presented by the National Institutes of Health (NIH).
How can you report serious problems to MedWatch?
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.
However, the FDA understands that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from FDA after your report is received. You will be personally contacted only if the FDA needs additional information.
There are three alternate routes for submitting an adverse event report:
Online: Use the interactive form at FDA Form 3500 to submit your report. FDA encourages online reporting because it is the quickest and most direct route.
Mail or Fax: Download a copy of the form and either fax it to 1-800-FDA-00178 or mail it using the postage-paid addressed form. (Send only page 1 plus any continuation pages - do not send instruction pages.)
Phone: Call the FDA at 1-800-FDA-1088 to report by telephone, Mon-Fri between 8:00 a.m. and 4:30 p.m. EST.
Tips for reporting an adverse event
1. Report what happened as soon as possible after you discover a problem. Be prepared with the following information:
* names, addresses, and phone numbers of people affected
* your name, postal and e-mail address, and phone number
* name, address, and phone number of doctor or hospital if emergency treatment was provided
* product codes or identifying marks on the label or container
* name and address of store where product was bought and date of purchase
* name and address of company on the product label
2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that will help FDA trace the product back to the plant.
3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.
4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator.
What happens after MedWatch receives your report?
***** FDA staff enter the report into a database so that it is available for review and comparison to other reports.
***** An FDA safety evaluator, often a pharmacist, doctor, or nurse, reviews the report and examines the database for similar reports.
***** FDA monitors the data for trends and conducts an investigation if appropriate.
***** FDA takes necessary action to protect public health.
FDA actions may include:
***** issuing safety alerts advising the public and health care professionals to monitor a product’s use, adjust the way it is used, or stop using it
***** updating the product labeling to reflect new warnings
***** requiring a product to have a Medication Guide a consumer-friendly instruction sheet provided to patients each time they fill a prescription to help them use the drug safely
***** requesting a change in the product’s design, manufacturing process, packaging, or distribution
***** requesting a company to recall a product or requiring a manufacturer to conduct further studies to demonstrate the product’s safety prior to allowing the product back on the market
Lisa Emrich is a patient advocate, accomplished speaker, author of the award-winning blog Brass and Ivory: Life with MS and RA, and founder of the Carnival of MS Bloggers. Lisa uses her experience to educate patients, raise disease awareness, encourage self-advocacy, and support patient-centered research. Lisa frequently works with non-profit organizations and has brought the patient voice to health care conferences and meetings worldwide. Follow Lisa on Facebook, Twitter, and Pinterest.