Published: 2 March 2023

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Gathering knowledge from adverse reaction reports: March 2023

Published: 2 March 2023
Prescriber Update 44(1): 17–18
March 2023

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: 145403
Age
: 50
Gender
: Female
Medicine(s)
: Bupropion + naltrexone
Reaction(s)
: Amnesia, headache
The patient experienced a type of blackout, during which she was fully functional but had no recollection of events. She went to bed and had a headache upon wakening.
Amnesia is listed as an uncommon adverse drug reaction in the Contrave data sheet. Headaches are also listed.
CARM ID: 144608
Age
: 66
Gender
: Male
Medicine(s)
: Ivermectin
Reaction(s)
: Generalised tonic-clonic seizure
A patient with COVID-19 self-medicated with ivermectin and had tonic-clonic seizures.
Ivermectin is not indicated for treatment of COVID-19. Seizures are listed as a very rare postmarketing ADR in the Stromectol data sheet.
CARM ID: 145103
Age:
67
Gender:
Male
Medicine(s):
Atenolol
Reaction(s): Hallucination, confusional state
After starting atenolol, the patient experienced command hallucinations that led them to act erratically and put their life in danger.
Hallucinations and psychoses are listed in the Atenolol Viatris data sheet.
CARM ID: 145181
Age
: 24
Gender
: Female
Medicine(s)
: Venlafaxine, rizatriptan
Reaction(s)
: Serotonin syndrome, drug interaction
A patient on venlafaxine was prescribed rizatriptan. She experienced palpitations, sinus tachycardia and clonus and was diagnosed with serotonin syndrome.
Rizatriptan (a triptan) and venlafaxine (a serotonin norepinephrine reuptake inhibitor; SNRI) are serotonergic medicines. The Rizamelt and Enlafax data sheets contain warnings for serotonin syndrome associated with concomitant use of triptans with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). These reactions can be life-threatening and involve altered mental status, autonomic instability and neuromuscular abnormalities.
CARM ID: 145293
Age
: 25
Gender
: Female
Medicine(s)
: Azithromycin
Reaction(s)
: Tongue discolouration
The patient’s tongue turned yellow after taking azithromycin.
Tongue discolouration is listed in the Apo-azithromycin and Zithromax data sheets.

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).
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