En Español 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 FDAUse one of the methods below to submit voluntary adverse event reports to the FDA: Guides to Reporting Problems to FDARelated 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.
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:
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:
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:
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 ReportWhen submitting a Reportable Event, you will need to have the following information ready:
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 ReportAll 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) 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 informationAdverse Event and Product Complaint Reporting |