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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

EMEA conclude NSAID review

In September it was reported that the European Medicines Agency (EMEA) announced that they would be updating their review of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The review is now complete according to this press release.

The EMEA have found that NSAIDs retain a positive benefit risk balance if used appropriately and following assessment of an individual patient's cardiovascular, gastrointestinal and renal risk factors.

The Medicines and Healthcare products Regulatory Agency (MHRA) have also issued a press release. The MHRA have also issued:

The main point of interest from the review is contained in the MHRA letter to health professionals. The review has found that diclofenac (particularly at 150mg/day) and ibuprofen (at high dose - 2400mg/day) may carry a small thrombotic risk. This same risk has not been established for naproxen.

  1. Where possible use Paracetamol based analgesia as first line with a ladder approach if initial analgesia fails.
  2. Review the patient for the overall risks involved with NSAID treatment - this should include an assessment of gastro-intestinal, cardio-vascular and renal risk as well as pre-treatment assessment of blood pressure and renal function.
  3. Where the overall risks are low or NSAID treatment is absolutely necessary despite moderate to high risk, the NSAID of lowest risk should be used at the lowest possible dose and for the shortest possible duration. This will usually mean that Ibuprofen is the first line NSAID.
  4. If Ibuprofen therapy fails or is not tolerated, re-assess the patient for an NSAID before trying an alternative. Suitable alternatives would include naproxen and perhaps diclofenac.

Action: This review provides clinicians with the latest information on NSAID safety. Clinicians should compare their current practice to this latest advice and make any necessary changes.

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2 Comments to “EMEA conclude NSAID review”

  1. […] As stated before, prescription of NSAIDs involves an assessment of GI, cardiovascular and renal risk. In patients at […]

    Pingback by GI risks of selective and non-selective NSAIDs | Prescribing Advice for GPs — December 4, 2006 #

  2. [...] the study was halted and states “the trial results cannot be reliably interpreted“. As recently reported, the European Medicines Agency (EMEA) assessed the safety of all NSAIDS and concluded that a [...]

    Pingback by Prescribing Advice for GPs » Cardiovascular safety of naproxen questioned — November 20, 2006 #

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