Published: 5 March 2020

Publications

Gathering knowledge from adverse reaction reports: March 2020

Prescriber Update 41(1): 14-16
March 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

Reaction description and data sheet informationb

CARM ID: 132502

Age: 57

Gender: Female

Medicine(s): Dapagliflozin

Reaction(s): Urinary tract infection, pyelonephritis

A female patient taking dapagliflozin for diabetes experienced urinary tract infection (UTI) symptoms for a week and then developed pyelonephritis with high fevers and rigors. She was hospitalised and the dapaglifozin stopped. The patient was reported to have had a UTI 3 months previously, also while taking dapaglifozin.

UTI and pyelonephritis are described in the Forxiga data sheet.

Urinary glucose excretion may be associated with an increased risk of urinary tract infection. Evaluate patients for signs and symptoms and treat promptly, if indicated. Temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis. Discontinuation of Forxiga may be considered in cases of recurrent UTIs.

CARM ID: 133295

Age: 19

Gender: Female

Medicine(s): Valaciclovir

Reaction(s): Acute kidney injury, abdominal pain

A female patient taking valaciclovir developed abdominal pain. Upon assessment, she was diagnosed with acute kidney injury and admitted to hospital. The symptoms resolved spontaneously.

Abdominal discomfort, renal impairment and acute renal failure are listed in the Valclovir data sheet.

CARM ID: 133836

Age: 8

Gender: Male

Medicine(s): Desmopressin

Reaction(s): Hyponatraemia, generalised tonic-clonic seizure

An 8-year-old patient had a suspected hyponatremic seizure approximately one month after starting treatment with desmopressin.

Hyponatremia and convulsions are listed in the Desmopressin PH&T data sheet.

When used for enuresis, fluid intake must be limited to a minimum for 1 hour before until 8 hours after administration.

Treatment without concomitant reduction of fluid intake may lead to water retention/hyponatremia with accompanying signs and symptoms (headache, nausea/vomiting, decreased serum sodium, weight gain and in serious cases, convulsions).

CARM ID: 134398

Age: 66

Gender: Female

Medicine(s): Bevacizumab

Reaction(s): Endophthalmitis, visual impairment

A female patient reported loss of vision 2 days after intravitreal injection of bevacizumab. She was diagnosed with endophthalmitis and treated with steroids and antibiotics, but the visual impairment remained.

Although bevacizumab (Avastin) is funded for intraocular use, this is not an approved indication.

The Avastin data sheet states that individual cases and clusters of serious ocular adverse events have been reported following unapproved intravitreal use of Avastin compounded from vials approved for intravenous administration in cancer patients. Some of these events have resulted in various degrees of visual loss, including permanent blindness.

These reactions can also occur with medicines approved for intravitreal treatment of macular degeneration.

CARM ID: 134937

Age: 32

Gender: Male

Medicine(s): Ciclosporin, posaconazole

Reaction(s): Drug interaction, drug level increased, generalised tonic-clonic seizure, renal impairment, thrombocytopenia

A 32-year-old transplant patient taking ciclosporin and posaconazole experienced a drug interaction and symptoms of ciclosporin toxicity including seizure, renal impairment and thrombocytopenia.

Ciclosporin is metabolised by CYP3A4 and posaconazole is a CYP3A4 inhibitor.

For transplant patients who cannot avoid concomitant use of medicines known to interact with ciclosporin, the Neoral data sheet recommends frequent measurement of ciclosporin levels and dose adjustment if necessary, particularly during introduction or withdrawal of the co-administered medicine. For non-transplant patients taking a concomitant medicine known to increase ciclosporin levels, frequent assessment of renal function and careful monitoring of ciclosporin-related side effects may be more appropriate than blood level measurement.

Notes:

  1. Only the medicines suspected to have caused the reaction are listed in the table.
  2. 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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