Published: 6 March 2025

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Gathering knowledge from adverse reaction reports: March 2025

Published: 6 March 2025
Prescriber Update 46(1): 12–13
March 2025

Adverse drug reaction (ADR) reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues with medicines and how they are used.

The table below presents a selection of recent informative cases reported to the New Zealand Pharmacovigilance Database.

Case detailsa,b	Reaction description and data sheet informationb,c
Report ID: 157971 Age: 38 years Gender: Male Medicine(s): Hydrocortisone + natamycin + neomycin Reaction(s): Penile ulceration	The patient developed penile ulcers after using Pimafucort cream. Pimafucort was withdrawn and the event resolved.
	Pimafucort should only be used for specific conditions when a combination of a corticosteroid, antimycotic and antibiotic is clinically indicated. It should not be applied to the genital area, including the foreskin, due to the risk of local skin reactions, such as rash or ulcerations. These reactions may be related to the neomycin component.
Report ID: 158368 Age: 40 years Gender: Female Medicine(s): Pregabalin Reaction(s): Amenorrhoea, weight increased, luteinising hormone (LH) increased, follicle stimulating hormone (FSH) increased	After starting pregabalin, the patient developed amenorrhea and weight gain. Pregabalin was discontinued and her periods resumed and hormone levels normalised.
	There is a warning for weight gain in the Lyrica data sheet. Amenorrhoea is listed as a rare ADR.
Report ID: 158607 Age: 6 years Gender: Female Medicine(s): Elexacaftor + tezacaftor + ivacaftor Reaction(s): Liver function tests (LFTs) increased, transaminases increased	After starting Trikafta, the child developed mildly elevated LFTs (increased transaminases). Three months later LFTs had markedly increased, and the medicine was stopped. Once LFTs had improved, Trikafta was restarted at a lower dose. LFTs immediately increased and the medicine was stopped again.
	There is a warning for elevated transaminases in the Trikafta data sheet. Transaminase and bilirubin levels should be monitored before and during treatment, a nd the data sheet provides advice on when to interrupt and/or resume treatment.
Report ID: 158657 Age: 15 years Gender: Male Medicine(s): Fluoxetine Reaction(s): Gynaecomastia	A year after starting fluoxetine, the patient developed gynaecomastia.
	Gynaecomastia is listed as a very rare ADR in the Arrow-Fluoxetine data sheet.
Report ID: 159035 Age: 38 years Gender: Female Medicine(s): Liraglutide Reaction(s): Acute cholecystitis necrotic	Four months after starting liraglutide, the patient developed acute gangrenous cholecystitis.
	The Saxenda data sheet has a warning for cholelithiasis and cholecystitis. Substantial or rapid weight loss can increase the risk of acute gallbladder disease. Inform patients about cholelithiasis and cholecystitis symptoms.
Report ID: 159549 Age: 7 years Gender: Male Medicine(s): Montelukast Reaction(s): Suicidal ideation	Three months after starting montelukast, the child developed suicidal ideation. The symptoms persisted after stopping the medicine.
	There is a warning for neuropsychiatric events in the Montelukast Viatris data sheet. Symptoms usually resolve after stopping treatment but have persisted in some cases. Before starting treatment with montelukast, prescribers should discuss the risks of neuropsychiatric events with patients and/or caregivers. Advise them to be alert for possible changes in mood and behaviour and to notify their doctor if these occur. See also the March 2024 Prescriber Update article: Unexplained mood and behavioural changes – could it be a side effect?

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, and do not always match the MedDRA term exactly.
3. If the suspect medicine’s brand name is not described in the ADR report, only the data sheet for the funded medicine is included in the table.

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

By selecting the ingredient of a medicine or vaccine, 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 and/or vaccines involved that contain the ingredient and the suspected adverse reactions (Detail report).