Fluoroquinolones: restrictions on use
Action at EU level The European Medicines Agency (EMA) has scientifically reassessed the serious, disabling and potentially permanent side effects of quinolone and fluoroquinolone antibiotics taken orally, injected or inhaled. This assessment also took into account the views of patients, healthcare professionals, and academia presented at the EMA public hearing on fluoroquinolone and quinolone antibiotics in June 2018. The Committee for Medicinal Products for Human Use (CHMP) agreed with the recommendations of the Pharmacovigilance Risk Assessment Committees (PRAC) and concluded that the marketing authorization of medicines containing cinoxacin, flumequine, nalidixic acid and pipemidic acid should be suspended. It was also decided that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the side effects, which impair the quality of life and may be permanent, are presented in technical information and instructions for use. Patients are advised to discontinue treatment with a fluoroquinolone antibiotic at the first sign of side effects affecting the muscles, tendons, or joints, or the nervous system.
The restrictions on the use of fluoroquinolone antibiotics mean that they should not be used:
- To treat infections that will resolve without treatment or are not serious (e.g., sore throats)
- To treat infections that are not caused by bacteria, such as nonbacterial (chronic) prostatitis
- To prevent traveler's diarrhea or recurrent lower urinary tract infections (urinary infections that do not extend beyond the urinary bladder)
- To treat mild or moderate bacterial infections unless other antibiotics commonly recommended for these infections cannot be used.
It is important to note that fluoroquinolones should generally be avoided in patients who have had previous serious adverse reactions with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in elderly patients, patients with kidney disease, and patients who have had an organ transplant, as these patients are at higher risk for tendon damage. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, the combined use of these two drugs should be avoided. The CHMP opinion will now be forwarded to the European Commission, which will adopt a legally binding decision for all member countries. National authorities will implement this decision for the fluoroquinolone and quinolone medicines approved in their countries and take further appropriate measures to ensure the correct use of these antibiotics.
Situation in Austria In Austria, medicinal products with the following active ingredients are approved:
- Ciprofloxacin,
- Levofloxacin,
- moxifloxacin,
- norfloxacin,
- ofloxacin,
- Prulifloxacin
The BASG has received 322 notifications on systemic fluoroquinolones in Austria since 01.01.2006.
BASG recommendations Recommend ations for pres cribers and users:
- Fluoroquinolones are associated with prolonged (over months or years), severe, quality-of-life-impairing, and possibly irreversible side effects affecting multiple, sometimes multiple, systems, organ classes, and senses.
- Serious side effects include tendonitis, tendon rupture, arthralgias, extremity pain, gait disturbances, neuropathies associated with paresthesias, depression, fatigue, memory impairment, sleep disturbances, hearing impairment, visual disturbances, and impaired sense of taste and smell.
- Tendon damage (especially damage to the Achilles tendon, but also to other tendons) may occur within 48 hours of starting fluoroquinolone therapy. However, the damage may also be delayed for several months after treatment is stopped.
- Elderly patients, patients who have kidney damage or have had an organ transplant, or patients treated with a corticosteroid are at higher risk for the occurrence of tendon damage. Concurrent therapy with a fluoroquinolone and a corticosteroid should be avoided.
- Treatment with fluoroquinolones should be discontinued at the first sign of tendon pain or tendonitis. In this case, patients should be instructed to discontinue treatment and contact the attending physician. This also applies if symptoms of neuropathy such as pain, burning, tingling, numbness or loss of strength occur, in order to prevent the development of a possibly irreversible condition.
- Fluoroquinolones should generally not be used in patients who have experienced serious adverse reactions associated with the use of quinolones or fluoroquinolones.
- If you are considering treatment with a fluoroquinolone for a patient, you should refer to the most current product information for information on the approved indications, as the indications for use for this group of drugs have been narrowed.
- The benefits and risks of fluoroquinolones are under ongoing review. A study on the use of these drugs will further investigate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by examining prescribing patterns.
Recommendations for patients:
- Fluoroquinolone drugs (containing active ingredients such as ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, and rufloxacin) can cause long-lasting, quality-of-life-impairing, and potentially permanent side effects, particularly to tendons, muscles, joints, and the nervous system.
- These serious side effects include inflammation or tearing of tendons, muscle pain or weakness, joint pain or swelling, difficulty walking, feelings of pins and needles or tingling, burning pain, fatigue, depression, memory problems, sleep disturbances, visual disturbances and hearing loss, and an altered sense of taste or smell.
- Swelling and injury to tendons may occur within two days of starting treatment with a fluoroquinolone, but may not occur for several months after treatment ends.
- Stop taking the fluoroquinolone and contact your doctor immediately in the following cases:
- at the first sign of a tendon injury, such as tendon pain or swelling - immobilize the affected area;
- if you feel pain, pins and needles, tingling, numbness or burning, or loss of strength, especially in your legs or arms;
- if you have swelling in your shoulders, arms, or legs; have trouble walking; feel tired or depressed; have memory problems or trouble sleeping; or if you notice changes in your vision, taste, smell, or hearing. Your doctor will work with you to decide if you can continue treatment or if you need a different antibiotic.
- You may be more susceptible to joint pain or swelling or tendon damage if you are over 60 years old, if your kidney function is limited, or if you have had an organ transplant.
- Talk to your doctor if you are taking or need treatment with a corticosteroid (anti-inflammatory drug such as hydrocortisone and prednisolone). You may be especially susceptible to tendon damage if you take a corticosteroid and a fluoroquinolone drug at the same time. Do not take a fluoroquinolone if you have ever had serious side effects with a fluoroquinolone or quinolone, and talk to your doctor about it right away.
- If you have any questions or concerns about your medicines, ask your doctor or pharmacist.
More information
Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are effective against both various gram-negative and gram-positive bacteria. Fluoroquinolones are an important therapeutic option against various infectious diseases, including life-threatening ones for which alternative antibiotics are not sufficiently effective. The reevaluation included the following agents from the group of fluoroquinolones and quinolones: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin. It only covered drugs administered systemically (orally or by injection) and drugs for inhalation.
More about the trial:
The reevaluation of fluoroquinolones and quinolones was initiated on February 9, 2017, at the request of the German Federal Institute for Drugs and Medical Devices (BfArM) under a procedure pursuant to Article 31 of Directive 2001/83/EC.
The evaluation was initially conducted by PRAC, which is responsible for evaluating safety issues related to medicinal products for human use.
The final recommendations of the PRAC were adopted on October 4, 2018, and subsequently forwarded to the CHMP, which is responsible for issues related to medicinal products for human use. The CHMP provided the opinion for the EMA.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision for all EU member states.
Further links:
European Medicines Agency press release (16.11.2018) https://www.ema.europa.eu/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-productsBackground: announcement of the public hearing (BASG, 20.04. 2018
) www.basg.gv.at/news-center/news/news-detail/article/fluorchinolone-oeffentliche-anhoerung-am-13062018-1236/ Summary of the public hearing (BASG, 13.06.
2018Questions (technical) :Dr. Christoph Baumgärtel, Tel: 050555/36004 Email: christoph.baumgaertel@ages.at Queries (for media):
Communications Management, Tel: 050555/25000 Email: presse@ages.at
