Published: 7 March 2024

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Gathering knowledge from adverse reaction reports: March 2024

Published 7 March 2024
Prescriber Update 45(1): 20–21
March 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: 148910 Age: 49 years Gender: Male Medicine(s): Pregabalin Reaction(s): Cognitive disorder, depression, weight increased	The patient experienced cognitive impairment soon after starting treatment with pregabalin. Depression and excessive weight gain were also reported. The symptoms improved with gradual down titration of pregabalin.
	Cognitive disorder (uncommon ADR), depression (common) and weight increased (common) are listed in the Pregabalin Pfizer data sheet.
Report ID: 153033 Age: 28 years Gender: Female Medicine(s): Paracetamol + codeine phosphate Reaction(s): Acute pancreatitis	Soon after taking paracetamol + codeine tablets, the patient experienced severe abdominal pains, which was diagnosed as pancreatitis. A few months later, she experienced another episode of pancreatitis soon after taking paracetamol + codeine tablets.
	Pancreatitis is listed as a very rare ADR in the Paracetamol +codeine (Relieve) data sheet.
Report ID: 153818 Age: 88 years Gender: Male Medicine(s): Entacapone Reaction(s): Excess sweating	A few days after starting entacapone, the patient experienced profuse sweating.
	Sweating increased is listed as a common ADR in the Comtan data sheet.
Report ID: 154467 Age: Not reported Gender: Female Medicine(s): Cetirizine Reaction(s): Rebound pruritus	The patient experienced intense itching after stopping treatment with cetirizine.
	The Razene data sheet states that pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
Report ID: 154548 Age: 79 years Gender: Male Medicine(s): Nivolumab Reaction(s): Myocarditis	The patient developed asymptomatic myocarditis following nivolumab treatment.
	Immune-mediated myocarditis is a known ADR for Opdivo. Promptly evaluate and closely monitor patients with cardiac or cardiopulmonary symptoms. However, some cases of myocarditis may be asymptomatic. The data sheet also describes treatment modifications according to the severity of the reaction. See also the June 2023 Prescriber Update article: Autoimmune complications of immunotherapy.

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, 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).