Published: 7 June 2019

Publications

Gathering knowledge from adverse reaction reports: June 2019

Prescriber Update 40(2): 38-39
June 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: 129304

Age: 60

Gender: Male

Medicine(s): Atorvastatin, ticagrelor

Reaction(s): Drug interaction, jaundice, abnormal hepatic function, urine discolouration

One month after being treated for myocardial infarction, a 60-year-old man experienced jaundice and dark urine. His liver function tests were abnormal. A ticagrelor-atorvastatin drug interaction was suspected. The symptoms resolved upon discontinuation of atorvastatin.
Atorvastatin is metabolised by cytochrome P450 3A4 (CYP3A4). Ticagrelor is primarily a CYP3A4 substrate and a mild inhibitor of CY3A4. The Lorstat and Brilinta data sheets state that co-administration of atorvastatin and ticagrelor increases the concentration of atorvastatin in plasma, although the increase was not considered clinically significant.

CARM ID: 130207

Age: 84

Gender: Female

Medicine(s): Tranexamic acid

Reaction(s): Pulmonary embolism

An 84-year-old woman presented to hospital after developing shortness of breath, nausea and sweating. She was diagnosed with pulmonary embolism. Three weeks earlier, tranexamic acid had been used after a dental extraction to prevent bleeding. The tablet had been dissolved in water to soak the gauze packing (it was not swallowed).
Pulmonary embolism is listed as an uncommon (0.1 to <1%) adverse event in the Cyklokapron data sheet.

CARM ID: 130978

Age: 66

Gender: Male

Medicine(s): Gliclazide, sulfamethoxazole + trimethoprim (co-trimoxazole)

Reaction(s): Drug interaction, hypoglycaemia

A diabetic patient on long-term gliclazide had reduced blood glucose levels after starting co-trimoxazole treatment for an infection.
The Glizide and Trisul data sheets state that sulfonamides can potentiate the blood glucose lowering effect of sulfonylureas.

CARM ID: 131210

Age: 70

Gender: Male

Medicine(s): Quinine

Reaction(s): Disseminated intravascular coagulation

A 70-year-old male taking quinine for cramps experienced disseminated intravascular coagulation.

Quinine is not indicated for treatment of cramps.

Intravascular coagulation is listed as an undesirable effect in the Q300 data sheet.

CARM ID: 131491

Age: 65

Gender: Female

Medicine(s): Candesartan, bendroflumethiazide, ibuprofen

Reaction(s): Drug interaction, acute kidney injury, orthostatic hypotension

A 65-year-old female patient on long-term ibuprofen and a thiazide diuretic developed reduced renal function and orthostatic hypotension after starting an angiotensin receptor antagonist.

The Candestar and Brufen SR data sheets state that concomitant use of NSAIDs, angiotensin receptor antagonists and thiazide diuretics increases the risk of renal impairment, especially in older patients or those with pre-existing renal impairment.

The Arrow-Bendrofluazide data sheet states that enhanced hypotensive effects may follow the concomitant use of thiazides and other antihypertensives.

See also the ‘Triple whammy’ discussion in the June 2013 Prescriber Update article, NSAIDs and acute kidney injury.

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).
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