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Biology and Genetics - Adverse Drug Reaction (ADR) from pharmaceuticals

Adverse drug reactions often go unreported after new medication comes on the market.

Adverse Drug Reactions (ADRs) are undesirable side effects to prescription and nonprescription drugs, medical devices and natural health products. All medicines have risks and benefits and are tested on a small sample of individuals before they are licensed. Although some adverse reactions are detected in the clinical trial, some ADRs may go undiscovered until the general population uses the medicines in a real-world setting. A number of groups such as pregnant women and children are also excluded from clinical trials representing key groups to assess suspected adverse reactions. Since only manufacturers are required to report ADR, a number of adverse reactions go unreported and incidence of ADR can’t be estimated. Regulatory agencies are encouraging health professionals and consumers to report suspected unwanted side effects.  Health Canada now has a public ADR database. It’s now recognized that incorporating active pharmacovigilance in a drug safety strategy and adopting a life-cycle approach to drug safety are important steps to protecting, promoting and improving public health. International collaboration and joint efforts between pharmaceutical manufacturers, regulators, doctors, pharmacists, patient groups and the general public are also essential for a successful post-market surveillance program.

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Contributor: Daniel Bedard

Last reviewed: June 2, 2010


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