Published: 6 December 2019

Publications

Gathering knowledge from adverse reaction reports: December 2019

Prescriber Update 40(4): 76–78
December 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.

Case detailsa	Reaction description and data sheet informationb
CARM ID: 130562 Age: 15 Gender: Female Medicine(s): Infliximab Reaction(s): Systemic lupus erythematosus (SLE), arthritis	A female patient with Crohn’s disease experienced polyarthritis in her fingers and toes one week after her routine infliximab dose. The rheumatologist diagnosed TNF inhibitor-induced SLE.
	Lupus-like syndrome is listed as an uncommon immune disorder in the Remicade data sheet.
CARM ID: 132796 Age: 64 Gender: Male Medicine(s): Vemurafenib Reaction(s): Stevens-Johnson Syndrome (SJS)	Eight days after commencing vemurafenib, a male patient was reported to have developed SJS with extensive skin, mucosal and conjunctival involvement.
	SJS is listed in the Zelboraf data sheet.
CARM ID: 133495 Age: 44 Gender: Male Medicine(s): Mesalazine Reaction(s): Myocarditis, pericarditis	A patient using both mesalazine suppositories and taking oral mesalazine developed chest pain, ECG changes and raised troponins. Mesalazine-induced myocarditis was suspected.
	Cardiac hypersensitivity reactions (myocarditis and pericarditis or pleuropericarditis) are described in the warnings and precautions sections of the Pentasa, Asacol and Asamax data sheets.
CARM ID: 133238 Age: 70 Gender: Female Medicine(s): Cannabidiol; Tetrahydrocannabinol Reaction(s): Suicidal ideation, confusional state, paranoia, urinary incontinence	A female patient started taking Sativex, increasing over a month to 5 sprays a day. She experienced confusion, paranoia, suicidal ideation and loss of bladder control. She stopped taking Sativex and was reported to have recovered.
	Disorientation is listed as a common undesirable effect in the Sativex data sheet, with paranoia and suicidal ideation listed as uncommon effects. The data sheet states that disorientation (or confusion), hallucinations and delusional beliefs or transient psychotic reactions have also been reported and in a few cases a causal association between Sativex administration and suicidal ideation could not be ruled out. In any of these circumstances, Sativex should be stopped immediately and the patient monitored until the symptom has completely resolved.
CARM ID: 133283 Age: 68 Gender: Female Medicine(s): Tetrabenazine Reaction(s): Facial paralysis, dysarthria, dysphagia	A female patient taking quetiapine and olanzapine was started on tetrabenazine. Two weeks later, she experienced progressive dysphagia and dysarthria, which rapidly worsened and she developed severe pseudobulbar palsy. Tetrabenazine was stopped and the patient made a gradual recovery over the next four weeks.
	The Motetis data sheet states that tetrabenazine can induce Parkinsonism. There is a potential for significant dopamine depletion when administering tetrabenazine concomitantly with neuroleptic agents, and patients should be monitored clinically for the development of Parkinsonism.
CARM ID: 133320 Age: 6 Gender: Male Medicine(s): Methylphenidate Reaction(s): Alopecia	Shortly after starting methylphenidate, a male patient developed alopecia. The medication was stopped, and his hair was reported to have almost fully regrown a few months later.
	Scalp hair loss is listed as a common adverse reaction in the Rubifen and Ritalin data sheets.

Notes:

1. Only the medicines suspected to have caused the reaction are listed in the table.
2. If the suspect medicine’s brand name is not described in the report to CARM, only the data sheet for the funded medicine is included in the table.

Information about suspected adverse reactions reported to CARM is available on the Medsafe website using the Suspected Medicines Adverse Reaction Search (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).