BfArM - Federal Institute for Drugs and Medical Devices

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Fluoroquinolones: severe and long-lasting side effects in muscles, joints and nervous system

Active substance: fluoroquinolones | quinolones

02.05.2019 - Explanation of the decision

In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.

08.04.2019 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission C(2018)2050 final of 11 March 2019 by decision of 28 March 2019.

16.11.2018 - CMDh opinion

The European Medicines Agency (EMA) has scientifically re-evaluated the serious, life-threatening and potentially persistent side effects associated with the group of fluoroquinolones and quinolones taken orally, injected or inhaled.

05.10.2018 - PRAC recommendation

PRAC recommends restrictions of use due to the quality of life restricting and possibly long-lasting side effects.

13.06.2018 - Public hearing

The European Medicines Agency (EMA) has opened registration for the public hearing that will take place in June 2018.

09.03.2018 - PRAC initiates public hearing for quinolone and fluoroquinolone antibiotics

The Pharmacovigilance Risk Assessment Committee (PRAC) has decided to organise a public hearing as part of the evaluation of fluoroquinolones and quinolones in order to hear directly the experience of interested parties so that they can be included in the Committee's recommendation.

10.02.2017 – Procedure started

The BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of Directive 2001/83/EC for antibiotics from the group of fluoroquinolones and quinolones.

Further Information

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):

BfArM - press release (available in German only)

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