Danish Pharmacovigilance Update, 18 August 2011

09 September 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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