Fluoroquinolone antibiotics are among the most commonly prescribed medications for a variety of bacterial infections. However, recent studies have highlighted the serious safety concerns associated with these drugs, particularly the risk of severe adverse reactions and death.
What are Fluoroquinolones?
Fluoroquinolones, also known as quinolones, are a class of broad-spectrum antibiotics that are widely prescribed for a range of conditions such as urinary tract infections, respiratory infections, and skin infections. Their effectiveness is due to their ability to target and kill bacteria by disrupting the DNA replication process.
However, over the past decade, there has been a growing concern over the safety of fluoroquinolones. In 2008, the U.S. Food and Drug Administration (FDA) issued a black box warning, the agency’s highest level of caution, for the use of fluoroquinolones due to the risk of tendon rupture and peripheral neuropathy.
Since then, additional safety concerns have emerged, including the risk of aortic aneurysm and dissection, QT interval prolongation, and hypoglycemia. But perhaps the most concerning side effect of fluoroquinolones is the risk of severe and sometimes fatal adverse reactions.
In 2016, the FDA updated its warning to include the risk of disabling and potentially permanent side effects, such as muscle and joint pain, nerve damage, and mental health disorders. The agency also cautioned that fluoroquinolones should only be used as a last resort for certain bacterial infections.
Despite these warnings, fluoroquinolones continue to be widely prescribed, and the number of reported adverse reactions and deaths associated with these drugs is on the rise.
One study published in the Journal of the American Medical Association (JAMA) in 2019 analyzed data from the FDA Adverse Event Reporting System (FAERS) and found that between 2008 and 2017, there were 5,369 reported deaths associated with fluoroquinolone use in the United States. Of these deaths, 2,931 were attributed to Cardiovascular, Cerebrovascular and Aortic Aneurysm and Dissection. The other 2,438 were associated with other adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and fulminant liver failure.
However, the authors of the study noted that the actual number of deaths and adverse reactions related to fluoroquinolones may be significantly higher than reported, as the FAERS database relies on voluntary reporting and is subject to underreporting.
Other studies have also highlighted the magnitude of the problem. One study published in the European Journal of Clinical Pharmacology in 2018 analyzed data from nine European countries and found that between 2008 and 2015, there were 5,020 reported cases of fluoroquinolone-related adverse drug reactions, including 247 deaths.
Another study published in the Journal of Antimicrobial Chemotherapy in 2018 analyzed data from the UK Clinical Practice Research Datalink and found that between 1998 and 2015, there were 15,326 cases of tendon disorders and 4,384 cases of peripheral neuropathy associated with fluoroquinolone use. Of these cases, 1,838 were severe and disabling.
Causes of Continued Use
The reasons for the continued use of fluoroquinolones are several. First, these drugs are often prescribed as a first-line treatment for bacterial infections, before the results of laboratory tests confirm the bacterial strain and its susceptibility to other antibiotics. This leads to the overuse and misuse of fluoroquinolones, which in turn increases the risk of adverse reactions.
Second, many healthcare professionals may not be aware of the updated warnings and guidelines issued by regulatory authorities regarding the use of fluoroquinolones. Therefore, they may continue to prescribe these drugs without adequate consideration of their potential risks.
Third, patients may also have a role in the continued use of fluoroquinolones. Many patients may prefer a quick fix for their symptoms and may pressure their healthcare providers to prescribe antibiotics, including fluoroquinolones.
To address the serious safety concerns associated with fluoroquinolones, several actions need to be taken. First, healthcare providers need to be better educated on the risks and benefits of these drugs and should only prescribe them as a last resort for specific bacterial infections.
Second, regulatory authorities should continue to monitor the safety of fluoroquinolones and consider stronger warnings and restrictions on their use.
Third, patients need to be educated on the appropriate use of antibiotics and the potential risks associated with fluoroquinolones. They should understand that antibiotics are not always necessary for bacterial infections, and that the overuse and misuse of antibiotics can lead to antibiotic resistance and adverse reactions.
The grim reality of fluoroquinolone-related deaths and adverse reactions is a serious public health concern that requires immediate attention. The continued use of these drugs without adequate consideration of their potential risks is contributing to unnecessary harm and death. Healthcare providers, regulatory authorities, and patients all have a role to play in ensuring the safe and appropriate use of antibiotics, including fluoroquinolones, to protect the health and well-being of individuals and communities.