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Original Research

Adverse drug reactions to off label use of drugs in spontaneously reported cases at a tertiary care hospital

Kalpana Suryabha Dudhal, Neha Ganesh Kadhe, Sudhir Pawar.


Background: Off-label prescribing is the prescription of medication in a manner different from that approved by the Food and drug administration (FDA). This term implies that the drug is given either for different indication, different dose, different dosage form, different route, or different age group as compared to the approval criteria. The safety data of drugs used for labeled use cannot be applied to safety of drugs during off-label use.

Aim and Objective: The aim of the study was to analyze the pattern of adverse drug reactions (ADR) occurring during off label use from the spontaneously reported ADR cases at the pharmacovigilance unit of a tertiary care hospital.

Materials and Methods: The spontaneously reported ADR cases at a tertiary care hospital ADR monitoring center were analyzed for off label use using the NFI-2016 and updates on www.cdsco.nic.in website.

Results: 82 ADRs occurred due to off-label use of drugs in 77 patients, these patients had received 433 medicines of which 231 were off label drugs. Off label drug use was maximum for systemically used anti-infective (152 drugs, 65.80%) and was associated with 75 ADRs (59.52%). Non-recommended co-administration of drugs was associated with maximum number of ADRs (23.01%). Most commonly affected organ system was skin and subcutaneous tissue (38.8%) and rash was the commonly occurring ADR.

Conclusion: Safety is always the main concern while prescribing drugs. Off-label use of drugs is associated with ADR and caution should be administered while prescribing. ADR monitoring is needed to reduce ADRs associated with off label use.

Key words: Adverse Drug Reaction; Off-label Use; Approved Use

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