Published: 6 June 2024

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Gathering knowledge from adverse reaction reports: June 2024

Published: 6 June 2024
Prescriber Update 45(2): 42–43
June 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 from the Centre for Adverse Reactions Monitoring (CARM)/Medsafe database.

Case detailsa,b	Reaction description and data sheet informationb,c
Report ID: 152982 Age: 74 years Gender: Female Medicine(s): Nitrofurantoin Reaction(s): Hepatitis, abdominal pain	Following a course of nitrofurantoin a week earlier, the patient experienced abdominal pain. Her liver function tests (LFTs) were abnormal, and she was diagnosed with hepatitis. Nitrofurantoin was discontinued and her LFTs slowly improved.
	Hepatic reactions, including hepatitis, are listed as rare ADRs in the Nifuran and Macrobid data sheets.
Report ID: 153407 Age: 53 years Gender: Female Medicine(s): Naltrexone + bupropion Reaction(s): Tinnitus	The patient developed severe tinnitus while taking Contrave.
	Tinnitus is listed as a common ADR in the Contrave data sheet.
Report ID: 153807 Age: 42 years Gender: Male Medicine(s): Amoxicillin, ibuprofen Reaction(s): Acute interstitial nephritis	Soon after starting treatment with amoxicillin, plus intermittent ibuprofen, the person developed severe renal impairment. Renal biopsy identified acute interstitial nephritis.
	Interstitial nephritis and tubulointerstitial nephritis are listed as very rare ADRs in the Alphamox and Brufen data sheets, respectively.
Report ID: 154727 Age: 65 years Gender: Female Medicine(s): Clopidogrel Reaction(s): Polyarthritis	After taking clopidogrel for a few weeks, the patient developed pain and swelling in her finger that then progressed to other joints. Clopidogrel was withdrawn and the symptoms resolved.
	Arthritis is listed as a very rare ADR in the Arrow-Clopid data sheet.
Report ID: 155052 Age: 9 years Gender: Male Medicine(s): Methylphenidate Reaction(s): Aggression	Within an hour of starting methylphenidate at a low dose, the child became severely agitated and aggressive.
	There is a warning about aggression, anxiety and agitation in the Rubifen data sheet. Monitor patients beginning treatment with methylphenidate tablets for the appearance or worsening of aggressive behaviour, marked anxiety or agitation.

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).