Quinolones may cause serious side effects – EMA/ PRAC warns!

EMA (European medicine agency’s) PRAC (pharmacovigilance risk assessment committee) has recommended restricting the use of systemic and inhaled fluoroquinolones because of the disabling and serious adverse effects of quinolones, following a safety review.

EMA/ PRAC recommends avoiding quinolones!

The EMA in a news release emphasized the potentially long-lasting and disabling side effects of fluoroquinolones on muscles, tendons, bones and nervous system. The PRAC recommended to avoid quinolones or use alternative antibiotics in case of mild infections like a sore throat.

adverse effects of quinolones

Serious adverse effects of quinolones – who are at risk!

Quinolones should also not be used to treat recurrent urinary tract infections. The PRAC has also alerted physicians to avoid the use of fluoroquinolones in elderly patients, those with kidney problems, those who have had organ transplantation and patients on steroids.

Patients should stop taking fluoroquinolone antibiotics at the first sign of a side effect. these include inflamed muscles, tendons or weakness, nervous system side effects like numbness, pins, and needles, depression, confusion, insomnia and hallucinations, vision and hearing problems.

Quinolones cover a broad spectrum of pathogens

Fluoroquinolones (and quinolones) are increasingly being used for the treatment of a variety of infectious diseases. This is primarily because of the broader spectrum of these antibiotics especially the enhanced coverage against gram-positive bacteria and tissue penetrating ability.

However, there use should be limited as serious adverse events have been associated with them.

Serious adverse effects of quinolones led the manufactures to withdraw these quinolones

The following quinolones have been withdrawn from the market because of their serious adverse effects:

  1. Grepafloxacin has been withdrawn from the market because of serious cardiac events.
  2. Trovafloxacin was associated with hepatotoxicity
  3. Gatifloxacin was associated with increased frequency of hypoglycemia and hyperglycemia.

adverse effects of quinolones

Physicians should be cautious as Gatifloxacin is still being marketed in Pakistan. Around 50 different brands are available in Pakistan.

Similarly, gemifloxacin is being used for mild to moderate respiratory tract infections but many individuals especially young females develop a skin rash if the duration is prolonged.

Comparing various fluoroquinolones …

Among quinolones, ciprofloxacin has better efficacy than other fluoroquinolones against gram-negative organisms, levofloxacin and moxifloxacin have greater potency against gram-positive organisms and moxifloxacin have enhanced activity against anaerobes.

Similarly levofloxacin, moxifloxacin has a promising role in the treatment of mycobacteria.

Fluoroquinolones are also effective against Mycobacterium fortuitum, kasasii and some strains of m.chelonae but have poor activity against Mycobacterium avium complex.

Use of fluoroquinolones in children:

Fluoroquinolones are not recommended for routine use in children less than 18 years of age because of the risk of arthropathy, and cartilage erosion in weight-bearing joints.

side effects of fluoroquinolones in children
avoid quinolones in children

Of the fluoroquinolones, ciprofloxacin has been approved for use in children with urinary tract infections and pyelonephritis.

Serious Adverse effects of quinolones:

Effect of fluoroquinolones on the gastrointestinal tract:

The gastrointestinal tract is the most frequently involved system. Most patients have a loss of appetite, nausea, vomiting and abdominal pain

Effect of fluoroquinolones on the Nervous system:

The nervous system is the second most common system affected. Patients may develop a headache, dizziness, insomnia and altered mood. Rarely patients may develop delirium, hallucinations, and seizures.

seizures caused by quinolones

The seizure threshold is lowered in patients on NSAIDs and theophylline. Patients may also develop muscle weakness especially those with myasthenia gravis. Respiratory failure and deaths have been documented after the use of fluoroquinolones in myasthenic patients.

Patients can also numbness, paresthesias or dysesthesias as a result of polyneuropathy due to fluoroquinolones.

Allergic manifestations of fluoroquinolones:

Rash, photosensitivity, fever, urticaria, serum sickness-like syndrome, vasculitis, and angioedema may occur rarely.

Arthropathy – the effect of quinolones on joints

adverse effects of quinolones
tendon rupture

Arthropathy, joint effusions, and cartilage erosions may develop. Tendinopathy and tendon rupture especially the Achilles tendon have been reported.

The FDA recommends to stop and report to a physician at the first signs of tendon pain, swelling or redness. Patients should stop exercising until the signs of inflammations are gone.

Similarly, transplant patients and patients on long-term steroids should also avoid the long-term and repeated use of fluoroquinolones.

Serious adverse effects of quinolones – Effect on the heart

QT prolongation due to fluoroquinolones
QT interval

Fluoroquinolones are notorious for causing life-threatening cardiac arrhythmias. QT prolongation leading to torsade de pointes (polymorphic ventricular tachycardia) can be life-threatening.

QT prolongation is more likely with the use of sparfloxacin followed by gatifloxacin and moxifloxacin. Levofloxacin, ciprofloxacin, and ofloxacin have a relatively minor effect.

adverse effects of quinolones
torsade de pointes

FDA recommends avoiding moxifloxacin, levofloxacin, and gemifloxacin in patients at risk of QT prolongation and torsade de pointes.

These include patients with hypokalemia, hypomagnesemia, and patients using class 1a drugs (quinidine, procainamide) or class 3 drugs (amiodarone and sotalol).

Serious adverse effects of quinolones – Liver toxicity

The drug most notorious for causing liver failure, trovafloxacin, has been withdrawn from the market. However, all quinolones can cause some degree of hepatic damage and cause transaminitis.

Serious adverse effects of quinolones – Hypoglycemia and hyperglycemia

Fatal episodes of hypoglycemia have been documented with fluoroquinolones. The most notorious drug, gatifloxacin, has been withdrawn from the market in the US.

This is important to emphasize that gatifloxacin is still being marketed in Pakistan by most of the companies. Almost 50 different brands are available in the Pakistani market. Physicians should try to avoid using gatifloxacin.

Hematologic effects of quinolones

Leukopenia and eosinophilia can occur but are rarely of sufficient severity to require cessation of therapy.

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