Published: 5 September 2024

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Gathering knowledge from adverse reaction reports: September 2024

Published: 5 September 2024
Prescriber Update 45(3): 62–63
September 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: 154140 Age: 46 years Gender: Male Medicine(s): Cyproterone acetate Reaction(s): Meningioma	A meningioma was discovered in a patient who was on long-term treatment with cyproterone acetate. The meningioma was removed and cyproterone stopped.
	The Siterone data sheet warns that meningiomas have been reported with prolonged (years) use of cyproterone acetate at doses of 25mg per day and above. Discontinue cyproterone acetate in patients diagnosed with meningioma. See also the September 2020 Prescriber Update article: Cyproterone acetate and the risk of meningioma.
Report ID: 154277 Age: 52 years Gender: Male Medicine(s): Nadolol Reaction(s): Asthma	After starting nadolol, the patient’s asthma symptoms worsened.
	Bronchial asthma or other obstructive lung disorders are listed as a contraindication in the Nadolol BNM data sheet.
Report ID: 156370 Age: 37 years Gender: Female Medicine(s): Sodium valproate Reaction(s): Polycystic ovarian syndrome	The patient was diagnosed with polycystic ovarian syndrome (PCOS) while taking sodium valproate.
	PCOS is listed as a rare ADR in the Epilim data sheet. Increased weight is common with valproate and may be a risk factor for PCOS.
Report ID: 156487 Age: 34 years Gender: Female Medicine(s): Pseudoephedrine Reaction(s): Abdominal pain, diarrhoea, rectal haemorrhage, muscle spasms, ischaemic colitis	A day after starting pseudoephedrine, the patient developed abdominal pain, diarrhoea, cramps and rectal bleeding, likely due to ischaemic colitis. Pseudoephedrine was stopped and the patient was recovering.
	Ischaemic colitis is listed as a very rare ADR in the Sudafed data sheet. Advise patients to discontinue pseudoephedrine and seek medical advice if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis 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).