Published: 13 December 2017

Gathering Knowledge from Adverse Reaction Reports: Dec 2017

Prescriber Update 38(4): 56
December 2017

Adverse reaction reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues concerning therapeutic products and their use.

A selection of recent informative cases from the Centre for Adverse Reactions Monitoring (CARM) database is presented below.

CARM ID: 120222
Age: 8
Gender: Male
Medicine(s): Omeprazole
Reaction(s): Depression
An 8-year-old boy taking omeprazole daily experienced symptoms of depression within a week of starting treatment. A similar effect had been noted when he had previously used omeprazole.
The Losec data sheet ( lists depression as a rare adverse reaction.
CARM ID: 122712
Age: 86
Gender: Male
Medicine(s): Amiodarone, Metoprolol, Atorvastatin
Reaction(s): Liver function test increased, hepatic cirrhosis
The patient's liver function tests were monitored after starting amiodarone. Two years after treatment initiation there was a mild elevation in the transaminases that persisted for another four years. In the subsequent year there was a further rise in transaminases. Approximately two years later a liver CT scan identified cirrhosis. The patient subsequently died.
The Cordarone X data sheet ( recommends regular monitoring of liver function tests during treatment. Elevation of liver enzyme levels occurs quite commonly. These changes appear to be dose dependent. The data sheet recommends reducing or discontinuing treatment if transaminase increase exceeds three times the normal range. These effects are usually reversible on stopping the medicine. However, fatal cases have been reported.
CARM ID: 119850
Age: 67
Gender: Female
Medicine(s): Simvastatin
Reaction(s): Acute kidney injury, CK level consistent with rhabdomyolysis
After taking simvastatin 80 mg per day for an unknown length of time the patient experienced acute kidney injury and an elevated CK level consistent with rhabdomyolysis.
The Arrow Simva data sheet ( states that in a clinical trial of patients treated with simvastatin 80 mg/day, patients 65 years and above had an increased risk of myopathy compared to patients under 65 years of age.
CARM ID: 124734
Age: 8 months
Gender: Male
Medicine(s): Chloramphenicol
Reaction(s): Neutropenia
An eight month old baby had been given chloramphenicol recurrently for an eye infection and developed neutropenia.
The data sheet for Chlorafast eye drops ( states that bone marrow hypoplasia has been rarely reported following local application. Chloramphenicol is absorbed systemically from the eye.