In a "red-hand letter" pharmaceutical companies warn of newly assessed risks of so-called fluoroquinolone antibiotics. Its application is therefore now severely restricted, some funds are completely withdrawn from the European market. The letter speaks of "quality of life affecting, long-lasting and possibly irreversible side effects".

Fluoroquinolones antibiotics are considered to be highly effective and are widely used, for example in urinary tract infections, tonsillitis or acute bronchitis. Doctors also prescribe the remedy, even if other drugs fail. They act, for example, in the dreaded hospital germ Pseudomonas aeruginosa, in necrotizing pancreatitis or in the anthrax pathogen.

However, the antibiotics can trigger violent side effects that affect mainly muscles, joints and the nervous system. These include tendinitis, tendon tears, muscle aches, nerve disorders, insomnia, depression, fatigue or limited memory. Some of the side effects occur over months to years and may persist permanently. (Here you can read more about it.)

Dangerous side effects from antibiotics Two tablets of pain

So far, only a few cases have been documented. However, a high number of unreported cases can be assumed since the symptoms are far from being recognized and documented as a side effect.

From now on, the drugs should therefore be prescribed only after a careful "benefit-risk assessment". In Germany, the following substances are involved:

  • ciprofloxacin
  • levofloxacin
  • moxifloxacin
  • norfloxacin
  • ofloxacin

For tonsillitis, acute bronchitis or for the prevention of urinary tract infections, the funds may no longer be used. In chronic lung diseases or inflammation of the bladder they only come into question if other antibiotics fail or have to be ruled out because of intolerance, for example. Doctors should not treat older people with fluoroquinolone. This also applies to patients with impaired kidney function or after organ transplants.

Anyone who is experiencing such symptoms after taking fluoroquinolones should stop taking the tablets and contact their doctor.

Underestimated danger

It has long been known that fluoroquinolones can cause severe side effects. In Germany, several remedies are no longer available because they sometimes had life-threatening side effects. Some of the drugs from the substance class are now being withdrawn EU-wide, but these funds were not approved in Germany. Why fluoroquinolones have so many side effects is still unclear.

So far, the current guidelines in Germany stipulate that fluoroquinolones should not be used as a first-choice drug in the treatment of bladder and sinusitis. The manufacturers also point out the side effects in the package insert. However, many physicians apparently underestimated the danger and yet prescribed the antibiotics. In 2015, 33.7 million daily doses of fluoroquinolones were prescribed in Germany.

The current new regulation is based on a Europe-wide risk assessment procedure initiated by the Federal Institute for Drugs and Medical Devices (BfArM) in 2017. The European Medicines Agency then examined the serious side effects.

Previously, the US Food and Drug Administration had drastically tightened the warnings for fluoroquinolones. In diseases such as sinusitis, bronchitis or uncomplicated urinary tract infection they should therefore only be used when no other antibiotic is effective.