Patient Safety and Risk Management 2016
DOI: 10.1136/ejhpharm-2016-000875.510
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PS-026 Data mining: Pharmacovigilance signal of benzodiazepines and skin and subcutaneous tissue disorders

Abstract: BackgroundPharmacovigilance uses data mining algorithms on spontaneous reporting databases to assess significant associations between adverse drug reactions (ADR) and drugs. These pharmacovigilance databases provide early warnings of hazards that were missed before marketing a drug, mainly because of the limitations of clinical trials. In July 2013, tetrazepam marketing was suspended, after four decades on the market, due to serious skin and subcutaneous tissue disorders (SSTD-ADR).PurposeTo detect possible ph… Show more

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