Published: 7 December 2023
Publications
Gathering knowledge from adverse reaction reports: December 2023
Published: 7 December 2023
Prescriber Update 44(4): 84–85
December 2023
Adverse reaction reporting is an important part 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) database.
Case detailsa,b | Reaction description and data sheet informationb,c |
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CARM ID: 143266 |
A child on long-term treatment with dexamfetamine was started on atomoxetine. Three months later she experienced dystonia of the jaw, which stopped following discontinuation of atomoxetine. |
Atomoxetine and dexamfetamine affect noradrenaline. The Aspen Dexamfetamine, Dexamfetamine (Noumed), Strattera and Apo-Atomoxetine data sheets describe the potential for additive or synergistic pharmacological effects with concomitant use of medicines that affect noradrenaline. The Aspen Dexamfetamine and Dexamfetamine (Noumed) data sheets also describe an interaction with atomoxetine. Concomitant use may lead to additive adverse effects, such as psychosis and movement disorders. The effects of amfetamines on mood and blood pressure may be reduced. |
|
CARM ID: 147932 |
Five days after starting orphenadrine, the patient developed visual and auditory hallucinations. |
Hallucinations (frequency unknown) are listed in the Norflex data sheet. |
|
CARM ID: 148121 |
Two days after starting oral sulfamethoxazole + trimethoprim (co-trimoxazole), the patient experienced nausea and vomiting. She subsequently developed a frontal headache, neck pain, photophobia and fever. She was diagnosed with aseptic meningitis. The patient had also experienced these symptoms following previous administration of co-trimoxazole. |
Aseptic meningitis is listed as a very rare adverse reaction in the Trisul data sheet. |
|
CARM ID: 148278 |
The child developed significant liver dysfunction one year after starting tocilizumab. The symptoms improved following discontinuation of tocilizumab and initiation of prednisone. |
The Actemra data sheet includes a hepatotoxicity warning in section 4.4. Serious hepatic injury, including acute liver failure, hepatitis and jaundice, has been reported between 2 weeks to more than 5 years after starting treatment. |
|
CARM ID: 148394 |
The patient commenced concomitant treatment with vildagliptin and lisinopril. One month later they developed swelling of the tongue, without rash. Treatment involved steroids, antihistamines and adrenaline, plus hospital admission. Lisinopril was discontinued. |
The Lisinopril (Teva) data sheet warns that angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors (ACE-inhibitors). Patients who only experience tongue swelling may require prolonged observation as treatment with antihistamines and corticoid steroids is not always sufficient. Advise patients to immediately report any signs or symptoms suggesting angioedema and to stop taking the medicine until they have consulted with their doctor. The Galvus data sheet states that angioedema has been reported with vildagliptin, and a greater proportion of these cases were reported when vildagliptin was administered in combination with an ACE-inhibitor. See also the March 2021 Prescriber Update article, Vildagliptin and ACE inhibitors – increased risk of angioedema. |
Notes:
- 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 exactly.
- 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).