Published: 1 December 2022
Publications
Gathering knowledge from adverse reaction reports: December 2022
Prescriber Update 43(4): 62–63December 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:
143883 Age: 59 Gender: Female Medicine(s): Escitalopram Reaction(s): Galactorrhoea |
A few days after starting escitalopram, the patient noted redness and swelling in the nipple and leakage of milk. |
| The Escitalopram (Ethics) data sheet states that galactorrhoea has been reported as a class effect for SSRIs (selective serotonin reuptake inhibitors). | |
| CARM ID:
143918 Age: 55 Gender: Female Medicine(s): Budesonide + formoterol Reaction(s): Paradoxical bronchospasm |
The patient experienced an increase in wheezing following use of her turbuhaler. |
| There is a warning for paradoxical bronchospasm in the Symbicort Turbuhaler data sheet. | |
| CARM ID:
144022 Age: 82 Gender: Female Medicine(s): Verapamil, metoprolol Reaction(s): Bradycardia, cardiac arrest, drug interaction, shock, ventricular fibrillation |
The patient experienced a cardiac arrest due to excessive atrioventricular (AV) blockade. Her verapamil dose had been increased several days earlier and she was taking a number of other medicines, including metoprolol. |
| The Isoptin
SR (verapamil) data sheet states that concomitant therapy
with beta-adrenergic blockers and verapamil may result in additive
negative effects on heart rate, atrioventricular conduction,
and/or cardiac contractility. There have been reports of excessive
bradycardia and AV block, including complete heart block, when
the combination has been used for the treatment of hypertension.
The combination should be used only with caution and close monitoring.
The Betaloc CR (metoprolol) data sheet also has information about the interaction. |
|
| CARM ID:
144385 Age: 60 Gender: Female Medicine(s): Celecoxib, ibuprofen + paracetamol Reaction(s): Abdominal pain, dizziness, drug interaction, medication error, melaena |
The patient experienced abdominal pain, melaena and dizziness. She had been prescribed celecoxib but was also self-medicating with ibuprofen and paracetamol (Maxigesic). |
| The Celebrex
data sheet has warnings for gastrointestinal effects. It states
that celecoxib should not be used with other non-steroidal anti-inflammatory
drugs (NSAIDs). The
Maxigesic data sheet has similar warnings, and states that
it should not be taken with any other anti-inflammatory medicines
unless under a doctor’s instruction. This case serves as a reminder for prescribers to check with patients about over-the-counter medicine use. |
|
| CARM ID: 144464 Age: 80 Gender: Male Medicine(s): Warfarin, miconazole Reaction(s): Drug interaction, INR increased |
A patient taking warfarin was prescribed topical miconazole. The patient’s international normalised ratio (INR) increased due to a drug-drug interaction between warfarin and miconazole. |
| The Coumadin
and Marevan
data sheets state that azole antifungals can potentiate the
effect of warfarin. As topical miconazole products are pharmacy-only medicines, they are not required to have a data sheet. However, manufacturer’s original packs are required to have the following warning statement:
|
- Only the medicines suspected to have caused the reaction are listed in the table.
- 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.
- 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 Medicine 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).
