Published: 3 March 2022

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Gathering knowledge from adverse reaction reports: March 2022

Published 3 March 2022
Prescriber Update 43(1): 9–10
March 2022

Adverse reaction reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues concerning therapeutic products and their use.

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: 141772 Age: 79 Gender: Female Medicine(s): Pregabalin Reaction(s): Visual hallucination	The patient experienced visual hallucinations following the third dose of pregabalin.
	Hallucination is listed as an uncommon ADR in the Pregablin Pfizer data sheet.
CARM ID: 141573 Age: 87 Gender: Male Medicine(s): Amiodarone Reaction(s): Skin discolouration	A patient on long-term therapy with amiodarone developed a blue-grey skin discolouration over his cheeks, nose and forehead.
	The Aratac data sheet states some patients have developed skin pigmentation (slate grey/purple colour) of the [sun] exposed areas. This pigmentation can be avoided if doses are kept as low as possible and may also be dependent on treatment duration. If the pigmentation is cosmetically unsightly, amiodarone should be discontinued if alternative therapy is possible.
CARM ID: 141395 Age: 1 month Gender: Male Medicine(s): Fluoxetine Reaction(s): Serotonin syndrome	The infant was exposed to fluoxetine via the mother’s breastmilk and experienced serotonin syndrome (hypertonia, hyperreflexia, akathisia, weight loss, reflux, distress). The infant was reported to have recovered.
	The Fluox data sheet states that fluoxetine is excreted in human milk and caution should be used when administered to breastfeeding women. Serotonin syndrome is listed as a very rare adverse reaction in the Fluox data sheet.
CARM ID: 141003 Age: 29 Gender: Female Medicine(s): Carbamazepine Reaction(s): Purpura	Soon after starting treatment with carbamazepine, the patient experienced non-traumatic bruising on her forearms. Carbamazepine was discontinued and the bruising resolved.
	Purpura (bruising) is listed as a very rare ADR in the Tegretol data sheet. Purpura may be also cutaneous manifestation of thrombocytopenia or agranulocytosis, which are listed in the data sheet as common and very rare ADRs, respectively. Complete pre-treatment blood counts, including platelets, should be obtained at baseline and periodically thereafter.

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.
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).