Adverse Event and Product Complaint Reporting
Part of Amgen's mission to serve patients includes collecting, reviewing and reporting all adverse events, other safety findings, and product complaint 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 on these Reportable Events.
It is Amgen's policy to comply with all regulations and laws worldwide relating to reporting adverse events, other safety finding and product complaints. Individuals subject to this policy are required to report adverse events, other safety finding and product complaints within one business day.
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;
- An AE that has been associated with the discontinuation of the use of a product; and
- Any lack or loss of intended effect.
Other Safety Findings
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
- Accidental or intentional medication errors or overdose of an Amgen product
- Misuse, where the Amgen product is intentionally and inappropriately used including misuse for illegal purposes
- Abuse, which is, intentional excessive use of an Amgen product
- Transmission of an infectious agent through a contaminated Amgen product
- Occupational exposure to an Amgen product (e.g., a Healthcare Provider is splashed with medicinal product while preparing an injection)
- Reports of patient "death" after exposure to an Amgen product where no other details are provided (e.g. fatal outcomes)
- Off-label use (OLU) of an Amgen product (e.g. a product is intentionally used to treat a condition for which the product is not indicated). U.S. Commercial field staff, please refer to the Adverse Event Reporting Policy.
Product Complaints (PC)
A PC includes 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 Amgen or by distributors and partners for whom Amgen manufactures the material. This includes all components distributed with the drug such as packaging, drug containers, delivery system, labelling, inserts, etc. Examples include:
- Device that is damaged or broken
- Bent or dull needles
- Missing or illegible labeling
- Inability of customer to administer the product
- Product with an unexpected color, appearance, or particles
What to Report
When reporting an AE, other safety finding or product complaint, you will need at 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.
You should still report AE, other safety findings and product complaints even if you do not have all the required information. Please report as much relevant information as possible.
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, other safety findings and product complaints must be reported. Report a reportable event even though 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 an AE, other safety finding or product complaint must be directed to Amgen for review and analysis as appropriate. Report adverse events, other safety findings, and product complaints 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)
Patients in other countries are encouraged to contact their local Amgen office or contact Amgen by calling 1-800-77-AMGEN (1-800-772-6436). Fax: +1-888-814-8653
AEs can also be reported to the FDA's MedWatch system or call +1 800-332-1088.
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