Pharmacovigilance or Drug Safety, as defined by the World Health Organization (WHO), is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.”

Drug Safety

An adverse drug experience is any adverse drug event associated with the use of drugs in humans, whether or not considered drug related, including:

  • An adverse event occurring in the course of the use of a drug product in professional practice
  • From drug overdose, drug abuse or drug withdrawal
  • Any failure of expected pharmacological action

Why and How to report an Adverse Event:

Reporting suspected adverse reactions is very important. It allows continual monitoring of the benefit/risk balance of the medicinal product. To report ADVERSE REACTIONS or SUSPECTED ADVERSE REACTIONS, contact Kedrion customer service at 1-855-353-7466 or FDA at 1-800-FDA-1088 or www.