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Posted now on the FDA website

Tears in the Aorta Blood Vessel in Certain Patients

AUDIENCE: Health Professional, Infectious Disease, Cardiology, Patient

ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

Healthcare professionals should:

  • Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
  • Prescribe fluoroquinolones to these patients only when no other treatment options are available.
  • Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
  • Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should:

  • Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.
  • Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.
  • Inform your health professional before starting an antibiotic prescription,  if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
  • Not stop the antibiotic without first talking to your health care professional.
  • Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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Dr. Restaino became involved in the national proton pump inhibitor litigation in 2016, initially in regard to the PPIs and acute interstitial nephritis/kidney disease litigation.  In November 2017, Dr. Restaino began putting together the PPI and gastric or esophageal cancer litigation, reviewing the initial 3 epidemiological studies published in November and December 2017 and then the March 2018 study looking at esophageal cancer. We have developed each on the main national experts involved in the litigation and Dr. Restaino went to Norway in February to meet with two of the major experts there, each of whom is now working with us. While Dr. Restaino did not discover the link between gastric and esophageal cancer and PPIs, he reviewed these published studies and brought them to the attention of the legal community. We continue to follow the science and epidemiology which now includes 8 epidemiological studies finding an association with gastric cancer, another 4 studies linking esophageal adenocarcinoma with the use of PPIs and, recently, 2 epidemiological studies linking PPIs with primary cancer of the liver.

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