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Parliamentary questions
PDF 34kWORD 16k
12 November 2019
 E-002942/2019
Answer given by Mr Andriukaitis
on behalf of the European Commission
Question reference: E-002942/2019

The evaluation of studies reviewed in a marketing authorisation or in the post-marketing setting is managed by the authorities in charge of the assessment for the medicinal product concerned (for fluoroquinolones they were mostly national competent authorities). The outcome of such review is public (e.g. publication of the assessment report). Although the medicines have been evaluated by different national agencies, the criteria for granting a marketing authorisation are identical across the EU.

In this context, authorities have to take into account the well-known effects of (fluoro)quinolones on the tendons. Over the past years, product warnings have been strengthened, especially on the use of these medicines for patients more prone to tendon damage.

The product summary advises that the medicine should be discontinued at the first sign of tendon swelling or pain. Similarly, such summary includes warnings about effects on the nervous system. This being said, before prescribing a medicine, a physician has to always consider whether the proposed therapy is adequate in view of the benefits and risks it involves and in view of the specific patient the doctor is treating.

Whilst these side effects of fluoroquinolones were known, new data emerged on the characteristics of these side effects, i.e. that some of these effects could be disabling, long-lasting and potentially permanent. In view of this new information, an EU review on the matter, a so-called Article 31 referral, was initiated in February 2017(1). The review was finalised in 2018 and its outcome is reflected for each (fluoro)quinolones in the annexes to the Commission Decision(2). Products subject to suspension are mentioned in Annex IA.

(1)https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products
(2)https://ec.europa.eu/health/documents/community-register/html/ho26765.htm
Last updated: 2 December 2019Legal notice