Published: 5 December 2024

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Gathering knowledge from adverse reaction reports: December 2024

Prescriber Update 45(4): 93–94
December 2024

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: 155224 Age: 54 years Gender: Female Medicine(s): Promethazine Reaction(s): Restless legs syndrome, dyskinesia	About an hour or so after taking a dose of promethazine, the patient developed extreme restless legs and involuntary jerky movements.
	Restlessness and extrapyramidal symptoms are listed in the Allersoothe data sheet.
Report ID: 155264 Age: Not reported Gender: Female Medicine(s): Liraglutide Reaction(s): Pancreatitis	The person developed pancreatitis after starting liraglutide.
	There is a warning about acute pancreatitis in the Victoza data sheet. Prescribers should inform patients about the characteristic symptoms of pancreatitis. If suspected, liraglutide should be discontinued. If pancreatitis is confirmed, liraglutide should not be restarted.
Report ID: 156555 Age: 13 years Gender: Male Medicine(s): Sumatriptan Reaction(s): Angioedema, oropharyngeal discomfort, pruritus	A patient with a history of hypersensitivity to sulfamethoxazole + trimethoprim developed facial angioedema, pruritis and oropharyngeal discomfort within 30 minutes of taking sumatriptan.
	The Sumagran data sheet states that patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan. Evidence of cross sensitivity is limited; however, prescribers should exercise caution before using sumatriptan in these patients. Sumatriptan should not be used in children as the safety and effectiveness has not been established.
Report ID: 157552 Age: 57 years Gender: Female Medicine(s): Sertraline Reaction(s): Microscopic colitis	Some weeks after starting oral sertraline, the patient developed symptoms of microscopic colitis with frequent loose bowel motions, urgency and some cramping abdominal pains. Biopsy confirmed microscopic lymphocytic colitis and sertraline was withdrawn.
	Microscopic colitis is listed in the Setrona data sheet. See also the December 2022 Prescriber Update article, Microscopic colitis - could it be caused by a medicine?
Report ID: 157692 Age: Not reported Gender: Female Medicine(s): Misoprostol Reaction(s): Bronchospasm	Within 2 hours of taking misoprostol, the asthmatic patient developed severe bronchospasm.
	The Cytotec data sheet states that bronchospasm may occur with some prostaglandins and prostaglandin analogues. This should be considered in patients with a history of asthma.
Report ID: 158113 Age: 55 years Gender: Female Medicine(s): Ropinirole Reaction(s): Impulse control disorder	During treatment with ropinirole, the patient experienced impulse control disorder, with symptoms of overeating, overspending and heightened, unwanted sexual arousal.
	The Ropin data sheet states that patients should be regularly monitored for the development of impulse control disorders. Inform patients and carers of the symptoms, including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating. Consider dose reduction/tapered discontinuation if such symptoms develop.

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).