Published: 8 June 2018

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Gathering Knowledge from Adverse Reaction Reports: June 2018

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Prescriber Update 39(2): 28
June 2018

Adverse reaction reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues concerning therapeutic products and their use.

The table below is a selection of recent informative cases from the Centre for Adverse Reactions Monitoring (CARM) database.

CARM ID: 126558 Age: 39 Gender: Female Medicine(s): Carbamazepine Reaction(s): Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)	Six weeks after starting carbamazepine, a 39-year-old female experienced a fine pimply rash which spread over the whole body and was associated with fever. Blood test results showed increased eosinophils and deranged LFTs.
	The Tegretol data sheet (www.medsafe.govt.nz/profs/Datasheet/t/Tegretoltabsyrup.pdf) lists two different HLA alleles associated with severe cutaneous adverse reactions, including DRESS. Also refer to the article on Pharmacogenomics in this edition of Prescriber Update.
CARM ID: 126816 Age: 64 Gender: Male Medicine(s): Olanzapine Reaction(s): Diabetic ketoacidosis	A 64-year-old male patient was given Zyprexa Relprevv (olanzapine). His condition deteriorated over the next few weeks. On admission to hospital he had a severe diabetic ketoacidosis. He had not been diagnosed as diabetic prior to this event.
	The Zyprexa Reprevv data sheet (www.medsafe.govt.nz/profs/Datasheet/z/zyprexarelprevvinj.pdf) states that hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Zyprexa Relprevv.
CARM ID: 127173 Age: 46 Gender: Male Medicine(s): Atorvastatin and amiodarone Reaction(s): Rhabdomyolysis	A patient taking 80 mg atorvastatin required an amiodarone infusion. A few days later the patient experienced a rise in CK, associated with rhabdomyolysis.
	The Cordarone infusion data sheet (www.medsafe.govt.nz/profs/Datasheet/c/CordaroneXtabinj.pdf) states that the risk of muscular toxicity is increased by concomitant administration of amiodarone with statins metabolised by CYP3A4 such as simvastatin, atorvastatin and lovastatin. Medsafe recommends using a statin that is not metabolised by CYP3A4, if a patient requires amiodarone.

Please continue to report adverse reactions to medicines to CARM (http://nzphvc.otago.ac.nz/report/).