In a “Red-Hand letter” to warn pharmaceutical companies in the face of newly assessed risks of so-called fluoroquinolone antibiotics. Your application will be restricted, therefore, from immediately, and some funds are taken from the European market. In the letter, the speech is of “reducing the quality of life, long-lasting side effects and may be irreversible”.
Antibiotics of the group of fluoroquinolones are considered highly effective and are widely used, such as in the case of urinary tract infections, tonsillitis, or acute Bronchitis. Doctors prescribe the means, even if other medications fail. They act, for example, in the case of the dreaded hospital germ Pseudomonas aeruginosa, necrotizing inflammation of the pancreas, or the spleen fire exciter.
However, the antibiotics can cause severe side effects, mainly on muscles, joints and the nervous system. This includes tendonitis, Tendon tears, muscle pain, nervous disorders, insomnia, depression, fatigue, or impaired memory. Some of the side effects occur for months to years and might exist permanently. (Read more about it here.)
So far, only few cases are documented. However, it is assumed that a high number of unreported cases, since the symptoms are not recognized for a long time, always as a side-effect and documented.
As of now, the medicines should be prescribed only after a careful “risk-Benefit assessment”. In Germany, the following substances relates to:
In tonsillitis, acute Bronchitis, or for the prevention of urinary tract infections may no longer be used. In the case of chronic pulmonary inflammation disease, or bladder, they only come in question when other antibiotics fail or, for example, because of incompatibilities must be excluded. Doctors should not treat older people with fluoroquinolone. This also applies to patients with impaired renal function, or after organ transplants.
Those who observed such symptoms after administration of fluoroquinolones, should not take the tablets and to the attending physician.
That fluoroquinolones can cause severe side effects, is known for a Long time. In Germany, several funds are no longer in the trade, because they had some live threatening side effects. Some of the remedies from the class are now being taken across the EU, from the market, these funds were not approved in Germany however. Why fluoroquinolones have so many side effects, is still unclear.
So far, the guidelines applicable in Germany wrote, fluoro-quinolones, bladder and sinus infections will not use as first choice. The manufacturers indicate in the package insert in addition, on the side effects. However, many Doctors appreciated apparently the risk of and prescribed the antibiotics yet. In the year 2015 in Germany 33.7 million daily doses of fluorine were prescribed quinolones.
The current revision goes back to a Europe-wide risk assessment process that had been initiated by the Federal Institute for drugs and medical devices (BfArM) in the year 2017. The European medicines Agency examined the serious side effects.
Previously, the FDA had tightened up the warnings for fluoroquinolones dramatically. In diseases such as sinusitis, Bronchitis or uncomplicated urinary tract infection they should therefore only be used if no other antibiotic is working.