Part of Amgen's mission to serve patients includes collecting, reviewing and reporting all Adverse Event or Adverse Experience (AE) information associated with the use of Amgen’s investigational or marketed products. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. It is Amgen’s policy to comply with all regulations and laws worldwide relating to AE reporting. Individuals subject to this policy are required to report AEs within one business day of learning of the AE.

An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes:

• Any clinically significant worsening of a pre-existing condition;
   
• An AE occurring from medication error or overdose of a product, whether accidental or intentional;
   
• An AE occurring from abuse (i.e., use for non-clinical reasons) of a product;
   
• An AE that has been associated with the discontinuation of the use of a product; and
   
• Any lack or loss of intended effect.

All information that pertains to an AE must be directed to Amgen Global Safety for review and analysis as appropriate. Amgen Global Safety can be reached at:

Phone: 8-447-3505 or +1-800-772-6436 (+1-800-77-Amgen)

Fax: +1-888-814-9653
 

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