miércoles, 9 de diciembre de 2009

OPINION OF THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE PURSUANT TO ARTICLE 5(3) OF REGULATION (EC) No 726/2004, FOR NONSELECTIVE NON STEROIDAL


OPINION OF THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE PURSUANT TO ARTICLE 5(3) OF REGULATION (EC) No 726/2004, FOR NONSELECTIVE
NON STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs)


Basis for opinion
On 21 September 2006, France presented a request to the CHMP for an opinion under Article 5(3) of Regulation (EC) No 726/2004 on the cardiovascular risks of non-selective non-steroidal antiinflammatory drugs (NSAIDs) in the context of their overall benefit/risk profile. This was due to newly available data on cardiovascular safety of non-selective NSAIDs stemming from clinical and epidemiological studies and concerns on the impact on the benefit-risk balance of these products. The grounds for this request are appended to this opinion (Appendix 1).

On the basis of the request made by France, the CHMP considered that there were sufficient grounds to start the procedure.

The procedure started on 21 September 2006.

Opinion
The CHMP, having considered the matter as set out in the appended assessment report (Appendix 2), is of the opinion that no public health concerns have been identified that are considered as being of Community interest, which would warrant an Article 31 referral. However, the CHMP agrees that the recommendations for use of non-selective NSAIDs should adequately reflect the current level of knowledge on thrombotic risk.

To this effect, the CHMP has recommended that its Pharmacovigilance Working Party (PhVWP) consider whether there is a need to revise the previously agreed key elements1 related to cardiovascular safety. Furthermore, the CHMP recommends that the outcome of the MEDAL2 programme should be analysed in more depth once complete results are available.

Possibilities for further epidemiological studies to obtain additional data on pertinent safety aspects of non-selective NSAIDs will be explored.

The CHMP agrees that the general prescribing advice and the advice to patients for NSAIDs remains as follows:
• Prescribers and patients should continue to use NSAIDs at the lowest effective dose for the shortest possible duration to control symptoms.
• Prescribers should continue to choose any NSAID on the basis of the overall safety profile of the product, as set out in the product information, and the patient’s individual risk factors.
• Prescribers should not switch between NSAIDs without careful consideration of the overall safety profile of the products and the patient’s individual risk factors, as well as the patient’s preferences.

1 Adopted key elements for the prescribing information of non-selective NSAIDs published in October 2005 and adopted key elements for the prescribing information of the non-selective NSAIDs piroxicam, ketoprofen and ketorolac published in September 2006
2 Multinational Etoricoxib versus Diclofenac Arthritis Long-term...

abrir aquí para acceder al documento EMEA completo en pdf de 5 páginas:
http://www.emea.europa.eu/pdfs/human/opiniongen/nsaids.pdf

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