Published: 3 December 2020


Gathering knowledge from adverse reaction reports: December 2020

Published: 3 December 2020
Prescriber Update 41(4): 75

December 2020

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: 136929

Age: 70

Gender: Female

Medicine(s): Chloramphenicol

Reaction(s): Aplastic anaemia

Following cataract surgery, the patient administered chloramphenicol eye drops for one week. Some months later, she developed fatal aplastic anaemia.

The Chlorafast data sheet includes a warning that aplastic anaemia and death have been rarely reported following local application of chloramphenicol. It states that chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

See also the Prescriber Update article, ‘A drop in the eye has widespread ripples’.

CARM ID: 137204

Age: 35

Gender: Female

Medicine(s): Zopiclone, sertraline

Reaction(s): Abnormal behaviour, delusion, euphoric mood, mania, nightmare

A patient on long-term sertraline was prescribed zopiclone. Shortly after taking the first dose, she experienced euphoria, mania, abnormal behaviour, delusion and nightmares.

The Zopiclone Actavis data sheet lists abnormal behaviour, delusion, euphoria and nightmares as possible adverse reactions. The Setrona data sheet also lists euphoric mood, mania and nightmares.

CARM ID: 137272

Age: 32

Gender: Female

Medicine(s): Nifedipine

Reaction(s): Product problem

A patient taking controlled release nifedipine noticed a pink pill in her stools a few times. The pills appeared to be intact, except that the coating was worn off in one spot.

The Adalat Oros modified release tablet has a pink coat with a small laser hole on one side. Section 5.2 of the data sheet states that, upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the faeces as an insoluble shell.

See also the Prescriber Update article, ‘Ghosts of medicines passed’.

CARM ID: 137729

Age: 60

Gender: Female

Medicine(s): Hydroxychloroquine

Reaction(s): QT prolongation

A patient taking hydroxychloroquine experienced cardiac dysrhythmia. An ECG showed an elongated QT interval.

The Plaquenil data sheet includes a warning for QT prolongation, and states that hydroxychloroquine has the potential to prolong the QTc interval in patients with specific risk factors, such as advanced age, uncorrected hypokalaemia and/or hypomagnesaemia, cardiac disease or treatment with other QT interval prolonging agents.

CARM ID: 137798

Age: 83

Gender: Female

Medicine(s): Omeprazole

Reaction(s): Metabolic acidosis, lethargy, nausea, renal impairment, tubulointerstitial nephritis

Within days of starting omeprazole, the patient felt unwell, lethargic, nauseated and short of breath. Upon admission to hospital she was found to have an acute kidney injury with metabolic acidosis – likely due to interstitial nephritis.

Interstitial nephritis is listed as a rare adverse reaction in the Omeprazole Actavis data sheet.


  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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