Published: 5 September 2019

Publications

Gathering knowledge from adverse reaction reports: September 2019

Prescriber Update 40(3): 56-57
September 2019

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: 131310 Age: 76 Gender: Female Medicine(s): Zoledronic acid Reaction(s): Uveitis, malaise	A 76-year-old woman developed malaise and uveitis after an infusion of zoledronic acid.
	Malaise and uveitis are listed as common and rare adverse reactions, respectively, in the Aclasta data sheet.
CARM ID: 132223 Age: 79 Gender: Female Medicine(s): Pregabalin Reaction(s): Peripheral oedema, sleep disturbed, (withdrawal reaction)	A 79-year old patient taking pregabalin for neuropathic pain experienced gradual onset of ankle oedema. Pregabalin was discontinued over three weeks and the ankle oedema resolved within four weeks. However, the patient experienced disturbed sleep for 10 days after discontinuation.
	The Pregabalin Pfizer data sheet states that withdrawal symptoms, including insomnia, have been observed in some patients after discontinuation of short-term and long-term treatment. Peripheral oedema is listed as a common adverse effect.
CARM ID: 132313 Age: 75 Gender: Male Medicine(s): Escitalopram Reaction(s): Ulcerative colitis, haemorrhagic diarrhoea	A 75-year-old man with a history of ulcerative colitis experienced a flare-up of his colitis with bloody diarrhoea shortly after starting escitalopram.
	The Escitalopram Apotex data sheet lists diarrhoea as a common adverse reaction. Abnormal bleeding, predominantly of skin and mucous membranes is listed as uncommon. Escitalopram should be used with caution in patients with a history of abnormal bleeding or those with predisposing conditions.
CARM ID: 132517 Age: 59 Gender: Female Medicine(s): Amiodarone, atorvastatin Reaction(s): Blood creatine kinase increased, drug interaction, muscular weakness	A 59-year-old woman on long-term atorvastatin experienced muscle weakness and increased blood creatine phosphokinase (CPK) levels after commencing amiodarone. An amiodarone-atorvastatin drug interaction was suspected. Her symptoms improved upon discontinuation of atorvastatin.
	Atorvastatin is metabolised by cytochrome P450 3A4 (CYP3A4), and amiodarone is a CYP3A4 inhibitor. The Aratac data sheet states that the risk of muscular toxicity is increased by concomitant administration of amiodarone with statins metabolised by CYP 3A4, including atorvastatin. The Lorstat data sheet states that concomitant use of CYP3A4 inhibitors can lead to increased atorvastatin plasma concentrations. Myopathy is listed as a rare adverse event in the Lorstat data sheet and should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine kinase (CK). Discontinue atorvastatin if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
CARM ID: 132541 Age: 21 Gender: Female Medicine(s): Ethinylestradiol + norethisterone Reaction(s): Hepatic enzymes increased, jaundice, lethargy, nausea, pruritus	A 21-year-old female taking long-term ethinylestradiol + norethisterone experienced nausea, lethargy, jaundice, itch and deranged liver function tests. Abdominal ultrasound and infection screen were normal.
	The Norimin data sheet states that certain endocrine and liver function tests and certain blood components may be affected by hormonal contraceptives, but abnormal liver function tests may indicate organ damage. Nausea (common) pruritus (frequency not known), cholestatic jaundice (rare), hepatocellular injury (eg, hepatitis, hepatic function abnormal; frequency not known) are listed as undesirable effects. Early identification can decrease the severity of hepatotoxicity when the medicine is discontinued.

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).