Published: 7 September 2023

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Gathering knowledge from adverse reaction reports: September 2023

Published: 7 September 2023
Prescriber Update 44(3): 67–68
September 2023

Adverse reaction reporting is an important part 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 from the Centre for Adverse Reactions Monitoring (CARM) database.

Case detailsa,b	Reaction description and data sheet informationb,c
CARM ID: 146140 Age: 51 years Gender: Male Medicine(s): Empagliflozin Reaction(s): Necrotising fasciitis (Fournier’s gangrene)	While taking empagliflozin, the patient experienced progressive worsening of a sore in the anogenital area. He became critically unwell with Fournier’s gangrene, which required extensive tissue debridement.
	There is a warning for necrotising fasciitis in the Jardiance data sheet. Patients treated with Jardiance who present with pain or tenderness, erythema, swelling in the genital or perineal area, fever or malaise should be evaluated for necrotising fasciitis. Urogenital infection may precede necrotising fasciitis. If necrotising fasciitis is suspected, discontinue Jardiance and promptly treat the patient (including broad-spectrum antibiotics and surgical debridement if necessary). See the Medsafe consumer leaflet, available in English, Te Reo and Samoan (PDFs, 2 pages, approx. 200 KB). See also the previous Prescriber Update articles: Reminder: Flozins and the risks of diabetic ketoacidosis and Fournier's gangrene Empagliflozin: advise patients on the risk of ketoacidosis and Fournier's gangrene.
CARM ID: 147682 Age: 10 years Gender: Male Medicine(s): Amoxicillin Reaction(s): Tooth discolouration	Following treatment with amoxicillin suspension, the child experienced front teeth discolouration.
	Superficial tooth discolouration is listed as a rare post-marketing adverse reaction in the Alphamox data sheet. Good oral hygiene may help to prevent tooth discolouration, as it can be removed by brushing.
CARM ID: 147125 Age: 64 years Gender: Female Medicine(s): Dulaglutide Reaction(s): Pancreatitis necrotising	The patient stopped taking dulaglutide as it made her feel unwell. She restarted treatment, and again felt unwell. This progressed to sudden onset abdominal pain, with very high lipase levels. She was diagnosed with acute necrotising pancreatitis.
	There is a warning for acute pancreatitis in the Trulicity data sheet. If acute pancreatitis is suspected, discontinue treatment until evaluation is complete. If confirmed, permanently discontinue Trulicity.
CARM ID: 146827 Age: 11 years Gender: Male Medicine(s): Cetirizine Reaction(s): Seizure	The child experienced a seizure following treatment with cetirizine. He had a history of seizures.
	The Zista data sheet states to use cetirizine with caution in epileptic patients and those at risk of convulsions. Convulsions are listed as a rare adverse reaction.
CARM ID: 146559 Age: 57 years Gender: Male Medicine(s): Adalimumab Reaction(s): Systemic lupus erythematous (SLE), rheumatoid arthritis, C-reactive protein increased, rash	Soon after starting adalimumab, the patient experienced a rash that spread to his limbs. His arthritis progressively worsened, with an increase in C-reactive protein. The reporter suspected a lupus-like reaction to adalimumab.
	SLE is listed as an uncommon adverse reaction in the Amgevita data sheet.
CARM ID: 147860 Age: 63 years Gender: Male Medicine(s): Liraglutide Reaction(s): Diarrhoea, anuria, acute kidney injury	The patient experienced severe diarrhoea soon after starting liraglutide therapy. He became anuric and went into renal failure.
	Gastrointestinal disorders, including diarrhoea, are commonly reported adverse reactions with Victoza therapy. They may occur more frequently at the beginning of therapy and diminish with a few days or weeks of continued treatment. Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported. Advise patients of the potential risk of dehydration due to gastrointestinal side effects and to take precautions to avoid fluid depletion.

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 exactly.
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)