EMA recommends restrictions on fluoroquinolone and quinolone

Organisation: Position: Deadline Date: Location:

The European Medicines Agency’s risk assessment committee has recommended restrictions on the use of broad-spectrum antibiotics fluoroquinolone and quinolone following a review of side effects, reports Reuters Health. The side effects were reported to be “disabling and potentially long-lasting”, though very rare, the EMA said. These side effects mainly involved muscles, tendons and bones and the nervous system, it added.

The Pharmaco-vigilance Risk Assessment Committee (PRAC) said the antibiotics should only be used to treat infections when an antibiotic is essential and others cannot be used. The PRAC recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market.

The report says the US Food and Drug Administration in July called for the safety labelling changes for fluoroquinolones to warn strongly about side effects including risks to mental health and serious blood sugar disturbances. In 2016, the FDA had issued warnings about the association of fluoroquinolones with “disabling and potentially permanent side effects”.

The PRAC also repeated its precautionary advice on the use of GlaxoSmithKline’s HIV drug dolutegravir in pregnant women and women who can become pregnant. US and European regulators were assessing whether the drug might be linked to serious birth defects, casting a shadow over a medicine that has been a key profit driver in recent years.

Dolutegravir is a so-called integrase inhibitor found in the branded medicines Tivicay and Triumeq, which are sold by GSK’s majority-owned ViiV Healthcare unit. Gilead Sciences makes a rival product called bictegravir.

The report says PRAC’s recommendations would now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP). While final approvals are up to the European Commission, it generally follows recommendations from the CHMP and endorses them within a couple of months.

Reuters Health report

Receive Medical Brief's free weekly e-newsletter



Related Posts

Thank you for subscribing to MedicalBrief


MedicalBrief is Africa’s premier medical news and research weekly newsletter. MedicalBrief is published every Thursday and delivered free of charge by email to over 33 000 health professionals.

Please consider completing the form below. The information you supply is optional and will only be used to compile a demographic profile of our subscribers. Your personal details will never be shared with a third party.


Thank you for taking the time to complete the form.