Published: 13 December 2018
Publications
Gathering Knowledge from Adverse Reaction Reports: December 2018
Prescriber Update 39(4): 58–59
December 2018
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.
| Details | Description |
|---|---|
| CARM ID: 127096 Age: 75 Gender: Female Medicine(s): Zoledronic acid Reaction(s): Renal failure resulting in death |
A 75-year-old woman was given an infusuion of zoledronic acid following a fracture. Several days later it was noted that her kidneys were failing. Despite treatment she did not recover and died. The report noted that the lack of hydration prior to treatment may have had an effect on the patient’s outcome. |
| The Aclasta data sheet (www.medsafe.govt.nz/profs/Datasheet/a/Aclastainf.pdf) states that patients must be appropriately hydrated prior to administration. This is especially important in the elderly and for patients receiving diuretic therapy. | |
| CARM ID: 128298 Age: 12 Gender: Male Medicine(s): Clonidine, methylphenidate Reaction(s): Reduced facial expression, epistaxis |
A 12-year-old boy taking methylphenidate was prescribed clonidine for behavioural issues. He then developed a ‘blank face’ and nose bleeds. |
| The Catapres (www.medsafe.govt.nz/profs/Datasheet/c/Cataprestabinj.pdf) data sheet states that there is little supporting evidence for use and safety of clonidine in children and adolescents. Use of clonidine in these populations therefore cannot be recommended. In particular, when clonidine is used off-label concomitantly with methylphenidate in children, serious adverse reactions, including death, have been observed. Therefore, clonidine in this combination is not recommended. | |
| CARM ID: 129124 Age: 17 Gender: Male Medicine(s): Isotretinoin Reaction(s): Proteinuria |
A 17-year-old male with normal renal function experienced fatigue some months after starting isotretinoin. Testing revealed proteinuria, which was thought to be a side effect of the isotretinoin. |
| Proteinuria is listed as a rare adverse effect in the Isotane (www.medsafe.govt.nz/profs/Datasheet/i/isotanecap.pdf) and Oratane (www.medsafe.govt.nz/profs/Datasheet/o/oratanecap.pdf) data sheets. | |
| CARM ID: 129288 Age: 36 Gender: Male Medicine(s): Felodipine Reaction(s): Gingival hyperplasia |
A 36-year-old man experienced gingival hyperplasia while on felodipine. The problem resolved once the medicine was discontinued. |
| Gingival hyperplasia is listed as a very rare adverse effect in the Felo ER (www.medsafe.govt.nz/profs/Datasheet/f/felotab.pdf) and Plendil ER (www.medsafe.govt.nz/profs/Datasheet/p/PlendilERtab.pdf) data sheets. | |
| CARM ID: 129199 Age: Unknown Gender: Male Medicine(s): Atorvastatin Reaction(s): Erectile dysfunction |
A male patient taking atorvastatin experienced erectile dysfunction, which resolved after atorvastatin was stopped. |
| The Lorstat data sheet (www.medsafe.govt.nz/profs/Datasheet/l/lorstattab.pdf) states that erectile dysfunction has been reported as an uncommon adverse effect in clinical trials. | |
| CARM ID: 128224 Age: 17 Gender: Female Medicine(s): Droperidol Reaction(s): Cardiac arrest |
A 17-year-old patient was administered IV droperidol for prevention of post-operative nausea and vomiting. She subsequently experienced ventricular fibrillation and cardiac arrest. |
| The Droperidol Panpharma (www.medsafe.govt.nz/profs/Datasheet/d/droperidolPanpharmainj.pdf) and Droleptan (www.medsafe.govt.nz/profs/Datasheet/d/droleptaninj.pdf) data sheets say cases of QT interval prolongation, ventricular arrhythmias and sudden death have been reported rarely. |
Information about suspected adverse reactions reported to CARM is available
on the Medsafe website using the Suspected Medicines Adverse Reaction Search
(SMARS) (www.medsafe.govt.nz/Projects/B1/ADRSearch.asp).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).
