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Serious side effects: pharmaceutical companies warn of common antibiotics
Several pharmaceutical companies as well as European and German authorities warn of several common antibiotics. These drugs can have serious and persistent side effects that can affect quality of life and may be irreversible.
Medicines with unwanted side effects
The use of antibiotics in the treatment of many diseases is clinically necessary, but it is often viewed critically. Finally, studies have shown that such drugs are often associated with serious side effects. Fluoroquinolone-containing agents have been particularly criticized. These can have "long-lasting and possibly irreversible side effects that impair quality of life", according to a current "Rote-Hand-Brief".
Broad spectrum of activity
"Medicines from the group of fluoroquinolones are highly effective synthetic antibiotics that have a broad spectrum of activity and are used in particular for serious bacterial infections," said the Federal Institute for Drugs and Medical Devices (BfArM) in an older announcement.
These drugs are an important treatment option for various infectious diseases, including some life-threatening ones, for which other antibiotics are not sufficiently effective.
However, the administration of the preparations is also accompanied by undesirable side effects, which is why their use should now be restricted.
Above all, the musculoskeletal system and the nervous system are affected
In a “Red Hand Letter”, pharmaceutical companies, in coordination with the European Medicines Agency (EMA) and the BfArM, warn of newly assessed risks of so-called fluoroquinolone antibiotics.
As it says, antibiotics containing quinolone and fluoroquinolone have been reported to have long-lasting and potentially irreversible adverse effects on quality of life.
These mainly affect the musculoskeletal system and the nervous system. Medicines containing the quinolones cinoxacin, flumequin, nalidixic acid and pipemidic acid are being withdrawn from the market.
In Germany, these drugs have never been approved or have not been approved for a long time.
In certain diseases, antibiotics should no longer be prescribed
Fluoroquinolones should not be prescribed for the following diseases:
- For the treatment of non-serious or self-limiting infections such as pharyngitis (throat inflammation), tonsillitis (tonsillitis) and acute bronchitis.
- To prevent traveler's diarrhea or urinary tract infections.
- For non-bacterial infections, e.g. non-bacterial (chronic) prostatitis.
- For mild to moderate infections such as chronic obstructive pulmonary disease (COPD), unless other antibiotics that are commonly recommended for these infections are considered unsuitable.
- In patients who have previously had serious side effects with a quinolone or fluoroquinolone antibiotic.
Particular caution is required with certain people
It should also be noted that special caution should be exercised when prescribing for the elderly, patients with renal impairment, patients with organ transplants and those who are being treated with corticosteroids as these may increase the risk of tendinitis and tendon rupture .
The simultaneous use of corticosteroids with fluoroquinolones should be avoided.
Doctors should advise their patients to stop treatment at the first sign of a serious side effect, such as tendinitis and tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system disorders, and contact their doctor for further advice.
Five active substances are affected in Germany
The new application recommendations are based on a Europe-wide risk assessment process that the BfArM initiated in 2017. The EMA then examined the serious side effects.
These mainly affect the musculoskeletal system and the nervous system. Among others, tendon inflammation, tendon tears, swelling of the joints, muscle pain, nerve disorders, insomnia, depression, fatigue (fatigue), limited memory as well as vision, hearing, smell and taste disorders are mentioned.
According to the experts, few cases of these quality of life and possibly irreversible side effects have been reported, but it is likely that not all side effects that have occurred have been reported.
The active substances ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin (ad) are affected by the restrictions in use in Germany.