Published: 7 March 2019

Publications

Gathering knowledge from adverse reaction reports: March 2019

Prescriber Update 40(1): 22–23
March 2019

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 presents a selection of recent informative cases from the Centre for Adverse Reactions Monitoring (CARM) database.

CARM ID: 129817 Age: 64 Gender: Female Medicine(s): Tramadol, venlafaxine Reaction(s): Serotonin syndrome, drug interaction	A 64-year-old female patient experienced serotonin syndrome whilst taking venlafaxine and after her regular dose of tramadol increased from 50 mg to 100 mg.
	Venlafaxine and tramadol are medicines with serotonergic effects. The Enlafax (www.medsafe.govt.nz/profs/datasheet/e/enlafaxXRcap.pdf) and Arrow Tramadol (www.medsafe.govt.nz/profs/Datasheet/a/arrowtramadolcap.pdf) data sheets state serotonin syndrome may occur with concomitant use of serotonergic medicines. See also the September 2015 Prescriber Update article ‘Reminder: Interactions resulting in serotonin syndrome’ (www.medsafe.govt.nz/profs/PUArticles/Sep2015/InteractionsSerotoninSyndrome.htm).
CARM ID: 129881 Age: 67 Gender: Male Medicine(s): Aripiprazole Reaction(s): Neuroleptic malignant syndrome	A 67-year-old male who had previously experienced neuroleptic malignant syndrome (NMS) with clozapine developed NMS following a single dose of aripiprazole. The patient subsequently died.
	The Aripiprazole Sandoz data sheet states that a potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including aripiprazole (www.medsafe.govt.nz/profs/datasheet/a/aripiprazolesandoztab.pdf). See also the December 2012 Prescriber Update article ‘Neuroleptic malignant syndrome or serotonin syndrome?’ (www.medsafe.govt.nz/profs/PUArticles/Dec2012Neuroleptic.htm).
CARM ID: 130055 Age: 35 Gender: Male Medicine(s): Gabapentin Reaction(s): Myoclonic jerks	A 35-year-old male patient taking gabapentin experienced myoclonic jerks, which resolved upon discontinuation.
	Myoclonus is listed as an adverse effect identified during post-marketing in the Apo-Gabapentin data sheet (www.medsafe.govt.nz/profs/Datasheet/a/ApoGabapentincaptab.pdf).
CARM ID: 130104 Age: 30 Gender: Female Medicine(s): Gabapentin Reaction(s): Eosinophilia, abnormal hepatic function, malaise, pruritic rash	A 30-year-old female taking gabapentin developed a severe itchy rash and malaise, and was noted to have liver test dysfunction and eosinophilia.
	These symptoms are suggestive of DRESS (drug rash with eosinophilia and systemic symptoms), which is listed in the Apo-Gabapentin data sheet (www.medsafe.govt.nz/profs/Datasheet/a/ApoGabapentincaptab.pdf).
CARM ID: 130571 Age: 58 Gender: Female Medicine(s): Cilazapril Reaction(s): Photosensitivity	A 58-year-old female patient who recently started cilazapril developed a severe sunburn reaction after a brief exposure to the sun (in October).
	Photosensitivity is listed in the Apo-Cilazapril (www.medsafe.govt.nz/profs/Datasheet/a/apocilazapriltab.pdf) and Zapril data sheets (www.medsafe.govt.nz/profs/Datasheet/z/zapriltab.pdf).

Information about suspected adverse reactions reported to CARM is available on the Medsafe website using the Suspected Medicines Adverse Reaction Search (SMARS) (www.medsafe.govt.nz/SMARS/).

By selecting the ingredient of a medicine you can find out:

• the number of reports and suspected adverse reactions for that ingredient. The suspected reactions are grouped by body system or organs (summary report)
• single case reports, listing the medicines involved that contain the ingredient and the suspected adverse reactions (detail report).