EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

(Reuters) – 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, the EMA said on Friday.

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 Pharmacovigilance 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 U.S. 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.

U.S. 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 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.