Danish Pharmacovigilance Update, February 2015
16 March 2015
The February issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:
News from the EU
- EMA tightens guidelines for use of hydroxyzine-containing medicines (Atarax®, etc.) to minimise the risk of heart rhythm disturbances, page 2
- EU's list of recommendations on safety signals, page 3
News from the DHMA
- Be aware of the risk of pulmonary fibrosis in long-term treatment with nitrofurantoin (Nitrofurantoin DAK) – new review and analysis by DHMA, page 4
- The number of melatonin users under 25 years of age keeps increasing, page 5
- DHMA keeps watch on isotretinoin for acne treatment, page 5
- DHMA has focus on ADHD medicines and cardiovascular disturbances, page 6
- Tramadol (Mandolgin®, etc.) and convulsions, page 7
- Pay attention to patient's renal function before and during treatment with the non-vitamin K antagonists Pradaxa®, Eliquis and Xarelto®, page 8
Short news
- Most recent Direct Healthcare Professional Communications (DHPCs), page 1