FDA Warns that Aortic Aneurisms Correlated with Certain Antibiotics
Research that was conducted between 2015 and 2018 indicates fluoroquinolone antibiotics may carry risks that outweigh the benefits of taking these medications. One of the more serious concerns is that the drug can cause aorticaneurysms.
Benefits and Risks of Fluoroquinolones
Fluoroquinolone antibiotics have a wide range of uses. This family of drugs can treat pneumonia, other respiratory infections. Urinary tract infections, and exposure to anthrax. The brand names for these drugs include “ciprofloxacin (Cipro), Gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin) and ofloxacin (Floxin).”
These medications are administered either orally or via injection. New studies now indicate that fluoroquinolone can lead to aortic aneurysms. Aortic aneurysmsare a bulge that forms in a person’s artery. The budge can grow and eventually burst. When this occurs, the result is dangerous bleeding that can in some instances be fatal.
Certain patients have greater risks of developing these complications. Elderly people, individuals who have high blood pressure, and those who have had previous aortic blockages or blockage of other blood vessels have a heightened chance of developing an aortic aneurysmfrom fluoroquinolone antibiotics. People who have been diagnosed with the genetic conditions Ehlers-Danlos syndrome or Marfan syndrome also have greater risks when taking this family of medications.
The relative risk associated with these drugs is low, but as compared to a control, patients talking the fluoroquinolone drugs show twice as high a rate of an aorticaneurysmas those who were not prescribed this form of treatment. Because of the significant increase in risk, doctors are now being advised to avoid prescribing this medication to anyone with a heightened risk of an aortic aneurysm.
In other patients, those who do not present with any of the additional risk factors, the chances of developing complications are very low. The benefits of treatment may still outweigh any risks for these patients as fluoroquinolone drugs have been used effectively for over 30 years.
Additional Warnings on Fluoroquinolones
The FDA is looking to have additional warnings and guidelines added to the drug labels because of the results of the study. Last July the FDA also issued a notice regarding this same family of drugs. The earlier notice indicated that the drugs could decrease a patient’s blood sugar and cause impairments to a patient’s mental health.
A warning about disabling effects on a patient’s nerves, muscles, central nervous system,andjoints was issued by the FDA in 2016.
Dating back to 2008, the FDA required that fluoroquinolones carry a boxed warning because studies indicated that these drugs increased a patient’s risk of developing tendinitis or of rupturing a tendon. An additional warning was added in 2011 when patients with myasthenia gravis, a rare autoimmune disorder, were shown to experience a worsening of their symptoms when they took the drug. In 2013, the labels were amended again to include a risk of irreversible peripheral neuropathy.
Patients have been advised to discuss the risks and benefits of these drugs with their medical providers. Even in patients with known risk factors, it is important to have a conversation with a doctor before discontinuing taking a prescription.
The FDA is charged with monitoring the safetyand effectiveness of medications in the United States. In some instances, the FDA will require that medicationberecalled if it is too dangerous. However, in other situations, even drugs with severe side effects can be beneficial or necessary for treating certain patients. In these cases, the FDA works to provide valuable information to patients and medical providers about the potential risks presented by a drug.
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