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Increased number of adverse drug reactions associated with oxaliplatin

Date: 19 August 2015

During the last year, the Netherlands Pharmacovigilance Centre Lareb sees an increase in the number of reports of adverse drug reactions associated with the use of oxaliplatine. Oxaliplatin is in combination with 5-fluorouracil and folinic acid indicated for use for adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced colorectal cancer.

The most common adverse reactions of oxaliplatin are gastrointestinal (diarrhoea, nausea, vomiting and mucositis), haematological (neutropenia, thrombocytopenia) and neurological (peripheral sensory neuropathy). Hypersensitivity, including anaphylactic or anaphylactoid reactions, usually occurs during infusion. The symptoms associated with these hypersensitivity reactions are rash, urticaria, angioedema, conjunctivitis, bronchospasm, hypotension, chest pain and anaphylactic shock.

From 1 January 2014 until 20 March 2015 the Netherlands Pharmacovigilance Centre Lareb received 42 reports considering possible adverse drug reactions associated with the use of oxaliplatin. The reported reactions include hypersensitivity reactions, paraesthesia, muscle spasm, bronchospasm and laryngospasm. Three reporters, all hospital pharmacists, mention in their initial report that they see an increase of known adverse drug reactions related to administration of oxaliplatin. The adverse drug reactions seemed to be more serious than they used to be, which resulted in some cases in termination of the treatment. One hospital pharmacist mentions seeing this issue after administration of oxaliplatin of multiple marketing authorisation holders, which suggests there might be a problem with the raw material of oxaliplatin.

The letter send to the Dutch Medicine Evaluation Board can be found here.

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