Published: 1 June 2023

Publications

Gathering knowledge from adverse reaction reports: June 2023

Published: 1 June 2023
Prescriber Update 44(2): 42–43
June 2023

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,b	Reaction description and data sheet informationb,c
CARM ID: 145519 Age: 68 Gender: Male Medicine(s): Mesalazine Reaction(s): Myocarditis, dyspnoea, malaise, cough	Soon after starting treatment with mesalazine, the patient experienced a dry cough, chest discomfort and shortness of breath. He was diagnosed with myocarditis, likely due to mesalazine.
	Myocarditis is listed as a rare adverse drug reaction in the Asacol and Pentasa data sheets. The Ascaol data sheet also includes a warning for cardiac hypersensitivity reactions, including myocarditis.
CARM ID: 145611 Age: 7 Gender: Male Medicine(s): Cyclopentolate Reaction(s): Seizure	A child with a history of epilepsy had a seizure following administration of cyclopentolate eye drops.
	The Cyclogyl data sheet states that seizures and acute psychosis induced by cyclopentolate are especially prominent in children. Cyclopentolate should be used with caution in children with known epilepsy.
CARM ID: 145769 Age: 13 months Gender: Female Medicine(s): Paracetamol Reaction(s): Medication error	Due to a medication error, the child received a supratherapeutic dose of paracetamol.
	To avoid medication errors with paracetamol, prescribe precisely and dispense diligently. Do not rely on colour and flavour because they can change. See the September 2019 Prescriber Update article: Paracetamol - Dangerous when not used correctly.
CARM ID: 145939 Age: 66 Gender: Male Medicine(s): Vildagliptin Reaction(s): Pemphigoid, histology	The patient experienced bullous pemphigoid during treatment with vildagliptin.
	The Galvus data sheet lists bullous pemphigoid as a postmarketing adverse drug reaction of unknown frequency. See also the March 2019 Prescriber Update article: Bullous pemphigoid - A blistering problem.
CARM ID: 146727 Age: 77 Gender: Female Medicine(s): Simvastatin, Rosuvastatin Reaction(s): Myocardial infarction, rhabdomyolysis, multiple organ dysfunction syndrome	A few weeks after starting rosuvastatin, the patient experienced cough, back pain, reduced urine output, and lower limb weakness. She was diagnosed with statin-induced rhabdomyolysis.
	The Rosuvastatin Viatris data sheet includes a warning about the effects of HMG-CoA reductase inhibitors on skeletal muscle (eg, myalgia, myopathy and, rarely, rhabdomyolysis). Rosuvastatin should be prescribed with caution in patients with pre-disposing factors for myopathy, such as renal impairment and older age. Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Notes:

1. Only the medicines suspected to have caused the reaction are listed in the table.
2. The reactions listed in the ‘Case details’ column are coded according to the Medical Dictionary for Regulatory Activities (MedDRA), an internationally used set of standardised terms relating to medical conditions, medicines and medical devices. The reactions listed in the ‘Reaction description’ column are based on what was reported to CARM, and do not always match the MedDRA term.
3. 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).