Who can report an adverse event (ae)?

In this section: Reporting Serious Problems to FDA

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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, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

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, we understand 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 when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.

Submitting Adverse Event Reports to FDA

Use one of the methods below to submit voluntary adverse event reports to the FDA:

Guides to Reporting Problems to FDA

Related Information for Consumers

Clinically important and timely information about the drugs and devices you use, prescribe, or dispense every day, delivered to your email from the FDA.

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Healthcare professionals are encouraged to report any clinically significant adverse event following vaccination to VAERS, even if they are not sure if vaccination caused the event.

Healthcare providers are required to report the following adverse events after COVID-19 vaccination, and other adverse events if later revised by CDC, to VAERS:

• Vaccination administration errors, whether or not associated with an adverse event
• Severe COVID-19 illness (e.g., resulting in hospitalization)
• Cases of observed Multisystem Inflammatory Syndrome
• Serious adverse events (AEs) regardless of causality. Serious AEs are defined as:
1.  Death;
2.  A life-threatening adverse event;
3.  Inpatient hospitalization or prolongation of existing hospitalization;
4.  Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
5.  A congenital anomaly/birth defect;
6.  Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.

Also report any additional select adverse events and/or any revised safety reporting requirements per FDA's conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 Vaccine being authorized under an Emergency Use Authorization (EUA).

Part of Amgen's mission to serve patients includes collecting, reviewing and reporting all Adverse Events (AEs), Other Safety Findings (OSFs), and Product Complaints (PCs) information associated with the use of Amgen's investigational and marketed products. Please refer to our Adverse Event and Product Complaint Reporting Policy for additional information

It is Amgen's policy to comply with all regulations and laws worldwide relating to reporting Adverse Events, Other Safety Findings and Product Complaints (collectively known as Reportable Events). Individuals subject to this policy are required to report all Reportable Events within one business day of learning of it.

Adverse Events (AE)

An AE is any untoward medical occurrence in a patient administered an Amgen product and which is not necessarily caused by the Amgen product. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, combination product, or medical device, whether or not considered related to the product. This includes:

• Any clinically significant worsening of a pre-existing condition; or
• An AE that has been associated with the discontinuation of the use of a product.

Other Safety Findings (OSFs)

The following are considered Other Safety Findings regardless of whether they are associated with an AE and they must be reported to Amgen:

• Use of an Amgen product while pregnant and/or breast feeding. This includes pregnancies in women whose sexual partner took, or is taking, an Amgen product.
• Medication errors
• Overdose
• Underdose
• Misuse is defined as the intentional improper use of a combination product or medical device not in accordance with the authorized product information.  In this case, the user deliberately used the combination product or medical device inappropriately causing difficulty administering the product.  Reports of misuse of a combination product or medical device are not considered product complaints
• Abuse
• Addiction
• Transmission of an infectious agent through a contaminated Amgen product
• Accidental Exposure
• Occupational Exposure
• Lack or loss of therapeutic efficacy
• Missed dose, if not taken prior to the next scheduled
• Unexpected therapeutic benefit
• Reports of patient "death" after exposure to Amgen's product where no other details are provided (e.g., fatal outcomes)
• Off-label use of an Amgen product defined as the intentional use of a product in a manner inconsistent with the locally approved label, i.e., a different dose, use, indication or patient population than that approved in the local label. U.S. Commercial field staff are not required to report off-label use unless the off-label use is associated with an AE. However, US Commercial field staff must report all other AEs, PCs and OSFs irrespective of whether the event is from on-label or off- label use.

Product Complaints (PC)

Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a drug, combination product, or device after it is released for distribution to market or clinic by either: (1) Amgen or (2) distributors or partners for whom Amgen manufactures the material. This includes all components distributed with the drug, such as packaging, drug containers, delivery system, labelling, and inserts.

Use Error is a situation in which the outcome of device use was different than intended, but not due to malfunction of the device. The error may have been due to a poorly designed device, or it may have been used in a situation that promoted incorrect usage.  Use errors are considered product complaints

What to Report

When submitting a Reportable Event, you will need to have the following information ready:

• The identifiable patient:
• The person who has taken or been administered the product (e.g. age, gender, etc.), in compliance with local privacy laws.
• An identifiable reporter:
• The source that reported the event (e.g. patient, health care provider, friend, etc.), in compliance with local privacy laws.
• The medicinal product:
• Amgen product name, indication and lot number if known.
• The reportable event:
• Description of the AE, other safety finding or product complaint.

Please report as much relevant information as possible. You should still report even if you do not have all the required information.

It does not matter whether the Reportable Event is thought to be caused or not thought to be caused by taking an Amgen product – all AEs, OSFs and PCs must be reported. Report it, even if it is listed in the approved company prescribing information as a possible side effect. When in doubt, report it.

How to Report

All information that pertains to a Reportable Event must be directed to Amgen for review and analysis as appropriate. Report Reportable Events related to any Amgen product to Amgen by calling:

In the US: 1-800-77-AMGEN (1-800-772-6436)
In Canada: 1-866-50-AMGEN (1-866-502-6436)

Reportable Events can also be reported to the FDA's MedWatch system or call +1 800-332-1088.

Healthcare Providers (HCPs)/patients in other countries are encouraged to contact their local Amgen Medical Information or Safety office or contact Amgen by calling 1-800-77-AMGEN (1-800-772-6436). Fax: +1-888-814-8653

U.S. Residents

For information about known risks and benefits of specific Amgen products, please visit our U.S. product websites to review prescribing information, including important safety information

Adverse Event and Product Complaint Reporting