Published: 2 September 2021

Publications

Gathering knowledge from adverse reaction reports: September 2021

Published: 2 September 2021
Prescriber Update 42(3): 41–42
September 2021

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: 139546 Age: 57 Gender: Male Medicine(s): Cyproterone Reaction(s): Meningioma	The patient had been on cyproterone therapy for a number of years. He developed a meningioma that required surgical excision.
	The Siterone data sheet states that occurrence of (multiple) meningiomas has been reported in association with longer term use (years) of cyproterone acetate at doses of 25 mg/day and above. If a patient treated with Siterone is diagnosed with meningioma, treatment with Siterone must be stopped. See also the September 2020 Prescriber Update article, Cyproterone acetate and the risk of meningioma.
CARM ID: 140019 Age: 65 Gender: Male Medicine(s): Azathioprine Reaction(s): Acute febrile neutrophilic dermatosis (Sweet syndrome)	The patient was diagnosed with Sweet syndrome (acute febrile neutrophilic dermatosis) which started within two weeks after commencing azathioprine. The patient was treated with corticosteroids and azathioprine was discontinued.
	Sweet syndrome is listed in the Imuran data sheet. See also the December 2020 Prescriber Update article, A bitter-Sweet syndrome with potential autoimmune connections.
CARM ID: 140139 Age: 42 Gender: Male Medicine(s): Hydrocortisone Reaction(s): Retinopathy	The patient was prescribed 1% hydrocortisone cream to treat widespread sunburn. Two weeks later the patient experienced blurry vision and was sensitive to bright lights. An ophthalmologist diagnosed central serous chorioretinopathy (CSCR).
	Visual disturbance may be reported with systemic and topical corticosteroid use. The Hydrocortisone Cream 1% PSM data sheet recommends referral to an ophthalmologist if a patient presents with symptoms such as blurred vision or other visual disturbances. Possible causes may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after use of systemic and topical corticosteroids. See also the September 2018 Prescriber Update article, Corticosteroids and Central Serous Chorioretinopathy (CSCR).
CARM ID: 141272 Age: 43 Gender: Male Medicine(s): Pentamidine Reaction(s): Hypoglycaemia	A patient receiving intravenous pentamidine treatment experienced sustained hypoglycaemia that required glucose and glucagon infusions.
	The Pentacarinat data sheet recommends that fasting blood glucose measurements should be taken daily during therapy, and at regular intervals after the completion of therapy. Hypoglycaemia is commonly reported in association with pentamidine treatment. The hypoglycaemia may be severe and fatal reactions have been reported. Hyperglycaemia and diabetes mellitus with or without preceding hypoglycaemia may occur up to several months after the cessation of therapy.
CARM ID: 140657 Age: 82 Gender: Female Medicine(s): Carbamazepine Reaction(s): Thrombocytopenia, epistaxis	Two weeks after starting carbamazepine, the patient experienced acute severe thrombocytopenia with epistaxis. The patient’s platelet count had been normal prior to starting treatment.
	Thrombocytopenia is listed as a common adverse reaction in the Tegretol data sheet. Leukopenia is listed as very common adverse reaction. Decreased platelet or white blood cell counts may be transient or persistent. Agranulocytosis and aplastic anaemia are listed as very rare adverse reactions. Complete pre-treatment blood counts, including platelets, should be obtained at baseline, and periodically thereafter. If the white blood cell or platelet count is definitely low or decreased during treatment, the patient and the complete blood count should be closely monitored. Discontinue treatment if any if any evidence of significant bone marrow depression appears.
CARM ID: 140808 Age: 9 Gender: Male Medicine(s): Theophylline Reaction(s): Supraventricular tachycardia	The patient was experiencing a severe asthma attack and was being treated with intravenous theophylline. He developed severe supraventricular tachycardia, which did not respond to increasing doses of adenosine but did revert with amiodarone.
	Tachycardia is listed in the DBL Aminophylline Injection BP data sheet. Aminophylline may antagonise the cardiovascular effects of adenosine by blocking of adenosine receptors.

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).