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THE PHARMA REVIEW (JANUARY – FEBRUARY 2014)

Side Effects Turned Therapeutically Useful - Off - Label Drugs

Vijay K Kapoor, Sonia Singla & Poonam Arora

Introduction: Drugs are discovered and developed to treat a particular disease. Each drug in clinical use has side effects. Some are minor, which are ignored and are advised to be tolerated. Some side effects are toxic and a measure of precautions is advised along with; and the side effects need to be monitored regularly through check ups. On the other hand there are many drugs which exhibit side effects found clinically useful for the disease other than the drug primarily used for. A prominent example is of aspirin, primarily discovered to be used as peripheral analgesic and antipyretic, but later found to be a useful as a cardiovascular drug because of its ability to prevent platelet aggregation. Its regular use in lower doses is recommended to prevent heart attacks. Several examples of drugs showing useful side effects and being therapeutically used for different diseases are emerging. In medical parlance such drugs are designated as ‘off-label’ drugs. Whereas any drug discovered and approved by the drug control authorities carries a label which lists approved use of the drug, its dosage, route of administration, conditions of usage and other relevant information, is referred to as ‘on-label’ drug. Prescribing a drug in a manner different from that approved by drug regulating agency is referred to as off-label use. 

 

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