Analysis and review of adverse drug reactions, safety alerts and drug recalls recorded by Health Canada MedEffect Programme over a period of one year

Adverse reactions (AR) are undesirable effects to health products. Health products include drugs, medical devices and natural health products. Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, serums, and blood derived products; cells, tissues and organs; disinfectants; and radiopharmaceuticals. The Food and Drug Regulations define an adverse drug reaction as a noxious and unintended response to a drug which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function. A serious adverse drug reaction requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.

Adverse Drug Reactions may occur under normal use conditions of the product. Reactions may be evident within minutes or years after exposure to the product and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage. Patients, health professionals, manufacturers and health product regulatory authorities need to work together to detect and monitor ARs. Voluntary reporting by health professionals and consumers of suspected reactions is the most common way to monitor the safety and effectiveness of marketed health products to obtain information regarding ARs.

Health Canada suggests that prevention and health promotion can hold health care costs down and improve quality of life in the long term. MedEffect e-Notice is a free service that sends health product alerts right to your e-mail inbox. MedEffect Canada uses a variety of mechanisms to share information and to help patients stay informed about advisories and recalls that are issued by Health Canada, as well as by Industry, for health products, such as pain relievers, cold medicines, prescription drugs, medical devices, vaccines and natural health products.

This paper consolidates analyses and reviews various adverse drug reactions, safety alerts and drug recalls reported over the past one year by Health Canada-MedEffect Programme. The goal of this short study is to raise awareness and provide facts and safety information about marketed health products and reported adverse reactions that are suspected of being associated with specific health products. Idea is to sensitize people about the importance of reporting adverse drug reactions to regulatory authorities for generating safety alerts, labeling changes and drug recalls in the interest of safety of patients.

 

Key Words: Adverse Drug Reactions; Safety Alerts; Drug Recalls; Health Canada; MedEffect