In Germany, fluoroquinolones are still widely prescribed: a group of antibiotics that can have serious side effects. Although these risks have been known for years, by 2018, more than three million patients benefiting from legal health insurance have received the corresponding preparations in this country. This is the result of a calculation from the scientific institute of AOK Health Insurance (WIdO). According to the extrapolation of the WIDO, 40,000 of the patients could be affected by torn tendons, lesions of the nervous system and the main artery.
Antibiotics treat infections caused by bacteria. In Europe, these prescriptions are less frequent in Germany, but their consumption has increased in that country between 1994 and 2014, according to the European Center for Disease Control and Prevention in Stockholm (ECDC). According to the WIdO, 310 million daily doses of antibiotics were prescribed in 2018, of which 8.2% or 25.6 million daily doses were for fluoroquinolone antibiotics, which are particularly severe.
According to the AOK data, the WIdO claims that 3.8 million patients in 2017 and 3.2 million patients in 2018 have been treated with a drug of this class of drugs. This corresponds annually to the five percent of the more than 72 million compulsory health insurances.
According to Stefan Pieper, the WIDO estimate of 40,000 adverse effects specific to fluoroquinolone is very conservative. Konstanz's general practitioner and expert on fluoroquinolone injury notes that, according to an independent classification of the report, reliable studies conducted in the United States would have allowed to obtain much higher figures. "Converted to Germany, that would be nearly 400,000 cases a year in Germany," said Pieper. In addition, only part of the possible side effects had been included in the file.
In the United States, the consequences of side effects are called "fluoroquinolone-associated disabilities" (FQAD) and are recognized as a disease. Pieper is currently working on the development of diagnostic criteria for the FQAD and has written the first specialist article in German on the subject. "I found at least 200 symptoms that can occur with the FAQD through this work," he concludes.
Side effects, according to Pieper, can be divided into four groups. On one side, fluoroquinolones attack collagen in the body, which can lead to torn tendons, retinal detachments and arterial tears. Second, these antibiotics have a neurotoxic effect that could cause long-term nerve damage, sometimes difficult to treat. A third potential side effect concerns neurotransmitters whose receptors could be blocked by fluoroquinolones. Patients would then become restless, anxious or panicked and may even develop suicidal tendencies. Finally, a chronic fatigue syndrome is possible – for Pieper, who has already found a variety of side effects in his practice, a particularly serious fate: "people who lose their jobs, know the social decline and disorganization of the family and, above all, we believe them the least ".
For Wolfgang Becker-Brüser of the journal "Arznei-Telegramm", it is incomprehensible given the possible and long-lasting side effects that fluoroquinolones are still prescribed for minor infections. "These are absolute reserves that should only be used if nothing else is done," said the doctor and the pharmacist. In fact, the Federal Institute for Drugs and Medical Devices (BfArM) published a "Rote Hand Brief" last April, according to which doctors should prescribe fluoroquinolones only in individual cases because of serious side effects. Previously, the Office launched a European risk assessment process in 2017.
For Becker-Brüser, these measures are too late: "Since the launch of the market in the 80s, funds have been criticized." In addition, the Federal Office of Health at the time recommended in 1989 strict indications concerning the prescription of fluoroquinolones, which were not mandatory. WIdO's forecasts are therefore seen as a "declaration of bankruptcy of drug surveillance", although the estimates must of course be treated with caution. Nevertheless, 11 of the 16 fluoroquinolone representatives available in Germany were withdrawn from the market 11, and some were shortly after their introduction: "This shows the potential for damage."
The WIDO report also points out that BfArM reacted late to known risks. When she questioned him, the authority replied in writing: "Since the beginning of the risk assessment process, BfArM has not only taken on the risks related to the use of fluoroquinolones, but has also participated and continues to participate in the surveillance and safety assessment of fluoroquinolone-containing drugs at European level. "
The Federal Institute refers to several red letters and publications on the subject, but also on the responsibility of doctors and patients: "It is essential for the safe use of a drug that users – doctors and patients – 'rely on product information texts Inform users of the risks associated with their use and ask patients to consult their doctor.' In addition, fluoroquinolones are approved in almost all European countries, and measures to change the conditions of authorization should be coordinated at European level.
Red hand letter / fluoroquinolones
Fluoroquinolones are subject to a red letter approval restriction
Here it goes to Article "Fluoroquinolones"
Wolfgang Becker-Brüser asks that at the earliest when approving medicines, the fields of application are clearly defined. If there are relevant restrictions after approval, clear warnings, such as those listed as "boxed warning" in the United States, are helpful. He sees concrete evidence in physician practice software, as advocated by the World Statistical Organization report, as the last possible step – similar to that of Pieper. The programs are not good enough yet.
In the meantime, stakeholders have gathered in an online forum (https://fluorchinolone-forum.de), which Pieper also recommends as a point of contact. Anyone who suspects side effects of fluoroquinolone, finds in the forum first evaluations and treatment plans. Wolfgang Becker-Brüser has another tip for victims: "Even if you need luck and a very good lawyer for medical law, you should not rule out a dispute."