Published: 2 June 2022
Publications
Gathering knowledge from adverse reaction reports: June 2022
Published 2 June 2022
Prescriber Update 43(2): 23–25
June 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: 141803 Age: 68 Gender: Female Medicine(s): Alendronic acid + Colecalciferol Reaction(s): Uveitis |
Two weeks after starting alendronic acid + colecalciferol, the patient developed gritty, red eyes, photophobia and reduced visual acuity, which worsened following each weekly dose. She was diagnosed with bilateral anterior uveitis. |
| Uveitis is listed as a rare ADR in the Fosamax Plus data sheet. | |
| CARM ID: 142360 Age: 12 Gender: Female Medicine(s): Lamotrigine Reaction(s): Stevens Johnsons syndrome |
Approximately three weeks after starting lamotrigine, the patient developed lesions on her lips. Lamotrigine was discontinued but the lesions continued. She also developed erythematous maculopapular lesions on her skin, back, face, chest, arms and palms. SJS was confirmed on biopsy. |
The Logem data
sheet states serious potentially life-threatening skin rashes,
including Stevens-Johnson syndrome, have been reported. The
risk of serious skin rashes in children is higher than in adults.
Physicians should consider the possibility of a medicine reaction
in children that develop symptoms of rash and fever during the
first eight weeks of therapy. In patients taking lamotrigine,
the overall risk of rash is strongly associated with:
|
|
| CARM ID: 142835 Age: 39 Gender: Female Medicine(s): Ethinylestradiol + Levonorgestrel Reaction(s): Cerebral infarction |
A patient taking long-term ethinylestradiol + levonorgestrel experienced a cerebral infarct. |
| The Levlen ED
data sheet contains warnings about the risks of arterial and
venous thromboembolism (ATE and VTE, respectively) and combined
oral contraceptives (COCs). Inform COC users of the symptoms
of ATE and VTE and advise them to seek urgent medical attention
if symptoms develop. See also:
|
|
| CARM ID: 143058 Age: 72 Gender: Female Medicine(s): Omeprazole Reaction(s): Drug rash with eosinophilia and systemic symptoms (DRESS) |
Three weeks after starting omeprazole, the patient developed a macular rash on her lower limbs that spread to her entire body. Blisters developed, and her eosinophil count was slightly raised. |
| DRESS is listed in the Omeprazole Actavis data sheet. See also the Prescriber Update articles: | |
| CARM ID: 143176 Age: 59 Gender: Male Medicine(s): Clobetasol propionate Reaction(s): Cushing’s syndrome |
The patient applied clobetasol propionate over his entire body for almost 6 weeks. He developed iatrogenic Cushing’s syndrome, with a moon face, adrenal suppression and diabetes. |
| Clobetasol propionate is a very potent topical corticosteroid.
The Dermol
data sheet states manifestations of hypercortisolism (Cushing's
syndrome) and reversible hypothalamic-pituitary adrenal (HPA)
axis suppression, leading to glucocorticosteroid insufficiency,
can occur in some individuals as a result of increased systemic
absorption of topical steroids. Risk factors for increased systemic
effects include potency and formulation of the corticosteroid,
duration of exposure and application to large surface areas.
See also the Prescriber Update article: Adrenal suppression associated with the use of topical steroids. |
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.
- 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).
