The London based European Medicines Agency, after a month long investigation, has decided that the benefit-risk balance of non-selective non-steroidal antiinflammatory drugs (NSAIDs) remains favourable.
The review, which was requested in September by France's national medicines agency, takes account of the publication of new data and analyses on thrombotic cardiovascular safety and develops initial recommendations made a year ago.
The European Medicines Agency's committee for medicinal products for human use concluded that non-selective NSAIDs provide important treatment for painful conditions such as arthritis. Against this, it advised that it could not exclude an association between their use and a small increase in thrombotic events, such as heart attacks or strokes, especially when used in high doses for long periods of treatment.
Overall the committee judged that the benefits of their use outweighed any possible adverse effects. In particular, it recommended that NSAIDs should be given according to the product information. The general safety profile of the respective nonselective NSAIDs, and gastrointestinal, cardiovascular, and renal risk factors for individuals should also be taken into account.
The review considered diclofenac, etodolac, ibuprofen, indometacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen, nimesulide, and piroxicam.
The committee confirmed its previous advice to doctors and patients to use the drugs in the lowest effective dose and for the shortest possible time. Doctors are advised not to switch patients from one NSAID to another without carefully considering the potential implications, and patients should not switch without consulting their doctor.
The European Medicines Agency said that it would continue to monitor non-selective NSAIDS and would take action if any concerns emerge. It is also continuing to conduct a benefitrisk assessment for piroxicam under the agency's referral procedure.