Danish Pharmacovigilance Update, 18 August 2011

In this issue of Danish Pharmacovigilance Update:

• Vimpat® 15mg/ml syrup (lacosamide) for treatment of epilepsy recalled due to a quality defect
• Nplate® (romiplostim) may increase the risk of disease progression in patients with myelodysplastic syndrome (MDS)
• Sprycel® (dasatinib) for treatment of certain types of leukaemia and risk of precapillary pulmonary arterial hypertension (PAH)
• MabThera® (rituximab) and risk of fatal infusion-related reactions in patients with rheumatoid arthritis
• Antipsychotic treatment during pregnancy and risk of withdrawal symptoms and extrapyramidal effects in newborns
• Hydrochlorothiazide is not recommended during breast-feeding – but no evidence suggests a contraindication
• Multaq® (dronedarone) study stopped due to cardiovascular adverse reactions
• Concomitant treatment with fusidic acid and statins cause increased risk of rhabdomyolysis
• The European Medicines Agency recommends limited use of anti-diabetic medicine with pioglitazone (Actos®)
• Limited availability of Thyrogen® (thyrotropin alfa) expected to continue in 2011 and 2012
• The European Medicines Agency still concludes that the benefits of the smoking cessation product Champix® (varenicline) outweigh the risks.
• Beta-blockers for ophthalmic use – harmonisation of product information with regard to the risk of systemic adverse reactions
• Update on Pandemrix® and narcolepsy
• The benefit-risk balance of reboxetine (Edronax®) remains positive
• Magistrally manufactured testosterone 10 % for topical use – risk of virilisation in children after exposure
• Long-term use of bisphosphonates and a risk of atypical fractures

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