Safety of Medicine

Risk of central nervous system adverse events

New Zealand. Medsafe has announced that the higher dose (7.5 mg) of zopiclone (Imovane®) is likely to cause central nervous system adverse events in the elderly.

Increased risk of recurrent thrombotic events

United Kingdom. The MHRA has announced that a clinical trial has shown that there is an increased risk of recurrent thrombotic events associated with rivaroxaban (Xarelto®) use compared to warfarin, in patients with antiphospholipid syndrome and a history of thrombosis.

Risk of rebound acid hypersecretion (RAHS)

New Zealand. Medsafe has announced that rebound acid hypersecretion (RAHS) has been reported in patients after stopping prolonged treatment with proton pump inhibitors (PPIs).

Risk of cardiovascular adverse events

New Zealand. Medsafe has announced that all nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a cardiovascular adverse event.

Potential risk of hemophagocytic lymphohistiocytosis (HLH)

Canada. Health Canada will work with the manufacturers of ipilimumab and nivolumab to determine appropriate label changes to the product safety information to include the potential risk of hemophagocytic lymphohistiocytosis (HLH). 

Risk of meningioma

Europe. The EMA’s PRAC has started a review of cyproterone (e.g. Androcur®) which will investigate the risk of meningioma, a rare, usually non-malignant tumour of the membranes covering the brain and spinal cord.

Risk of hepatotoxicity

New Zealand. Medsafe has announced that hepatotoxicity is the most significant risk of harm with vildagliptin.

Vildagliptin is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.

Possible risk of opioid effects in breastfed babies

New Zealand. Medsafe has announced that CARM received a case report where a neonate suffered feeding disorder, somnolence (sleepiness), respiratory disorder and weight decrease while the breastfeeding mother was taking tramadol (Tramal® and Arrow®).

Rare risk of hepatic injury

Ireland. The HPRA has announced that serious cases of drug-induced liver injury, (such as acute liver failure, hepatitis and jaundice and cases requiring liver transplantation) have been observed in patients treated with tocilizumab (RoActemra®).

Dangerous when not used correctly

New Zealand. Medsafe has announced that they have received cases of serious adverse events related to medication errors associated with prescribing, dispensing and communication to caregivers in children.