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Canada Expands Fluoroquinolone Antibiotic Warning

pills on a spoon, one with the Canadian flag symbol

Health Canada linked antibiotics called fluoroquinolones to a wide range of disabling side effects and wants manufacturers to update medication labels, CBC News reported.

The action by Health Canada follows safety communications by the U.S. Food and Drug Administration advising health care professionals to only use antibiotics such as Cipro, Avelox and Levaquin as a last resort because the risks may outweigh the benefits.

A Summary Safety Review published by Health Canada on Jan 23 identified reports of persistent and disabling side effects. These side effects include tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders.

In addition to these side effects, Health Canada reviewed reports of known side effects linked to fluoroquinolones, such as:

In addition to these side effects, Health Canada reviewed reports of known side effects linked to fluoroquinolones, such as:

  • Worsening of myasthenia gravis (a chronic autoimmune disease)
  • Hypersensitivity and serious skin reactions
  • Mental disorders
  • Depression and suicide/self-injury
  • Convulsions (seizure)
  • Cardiovascular disorders
  • Phototoxicity (light sensitivity)
  • Vision disorders

The Canadian agency said it would continue to monitor the safety of these drugs. It is currently working with the Drug Safety and Effectiveness Network (DSEN) and the Canadian Agency for Drugs and Technologies in Health (CADTH) to conduct additional studies.

“Health Canada recommended that the safety information for all fluoroquinolone products be updated to include information about this rare but serious risk,” the agency said in its Summary Safety Review. “Health Canada is working with manufacturers to update the safety information of all systemic (taken by mouth or by injection) fluoroquinolone products marketed in Canada.”

FDA Linked Drugs to ‘Permanent, Disabling Side Effects’

About 26 million Americans take a fluoroquinolone antibiotic each year. Because they treat a wide variety of infections from sinus infections to anthrax, prescriptions skyrocketed over the past several years.

The Centers for Disease Control and Prevention estimates doctors write about half the prescriptions in the U.S. for viral conditions such as the flu or a cold, the Washington Post reported. These illnesses do not respond to antibiotics.

In July 2016, the FDA approved drug label changes to warn of “disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.”

According to the FDA, the disabling side effects involve “tendons, muscles, joints, nerves and the central nervous system.” The agency warns “these side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.”

The latest studies on fluoroquinolones link them to dangerous aortic aneurysms (ruptures) and aortic dissections (tears). Researchers suspect the drugs break down the body’s collagen, a substance that makes up tendons and the lining of the aorta.

One 2015 JAMA study found a two-fold increase in risk of aortic aneurysm and dissection. Another in BMJ found a three-fold increase in risk of aortic aneurysm.

Thousands of Adverse Events and Lawsuits

RxISK.org, an independent site run by researchers, combed the FDA’s data over the course of 10 years. It found 80,000 adverse drug reactions possibly associated with Levaquin and generic levofloxacin, including 1,000 deaths. For Cipro and generic ciprofloxacin, the total was 79,000 adverse events including 1,700 deaths.

Thousands of patients document their fluoroquinolone injuries across the internet on patient forums. Some filed lawsuits, claiming drugmakers failed to warn about serious side effects.

At one time, Johnson & Johnson faced several thousand lawsuits over Levaquin. Some are still pending before Judge John R. Tunheim in Minnesota. A separate multidistrict litigation for other fluoroquinolones — also before Judge Tunheim — currently has more than 700 lawsuits.

Last modified: July 12, 2017


Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.

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  1. Gajewski, M. (2017, January 23). Widely used antibiotic linked to rare but serious side-effects: safety review. Retrieved from http://www.ctvnews.ca/health/widely-used-antibiotic-linked-to-rare-but-serious-side-effects-safety-review-1.3253938
  2. Davidson, I. (2015, August 3). It pays to read the warnings when you open up a prescription. Retrieved from https://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html