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EMA review of cardiovascular safety of NSAIDs
The European Medicines Agency (EMA) has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs). The review confirms the findings from previous reviews which concluded that the overall benefit-risk balance of NSAIDs remained positive, but that a small increased cardiovascular risk could not be excluded.
Most of the data related to diclofenac, ibuprofen and naproxen. The latest evidence continues to find a small increase in the risk of cardiovascular undesirable effects for diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors, particularly with long-term use of high doses and in patients already at high risk. Warnings are already included in the Summary of Product Characteristics (SPC). However, the EMA will now assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice. In relation to naproxen and ibuprofen, the current treatment advice adequately reflects the knowledge regarding their safety and efficacy.
Fatal cases of severe symptomatic hypocalcaemia with denosumab
The UK Medicines and Healthcare products Regulatory Agency …
Competing interests None.
Provenance and peer review Not commissioned; internally peer reviewed.