Fluoroquinolone Warning Labels to be Updated in Canada

Health Canada, the department of the government of Canada with responsibility for national public health (like the U.S. Food and Drug Administration) has “carried out a review of the potential risk of persistent and disabling side effects linked to the use of fluoroquinolones. The review was triggered by a benefit and safety review done by the United States Food and Drug Administration (FDA) on systemic (taken by mouth or by injection) fluoroquinolone drugs.”

The Canadian Review of fluoroquinolones concluded that (SOURCE):

  • Health Canada’s review concluded that some of the known side effects, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders, already linked to the use of fluoroquinolones, may be persistent and/or disabling. Given the high use of fluoroquinolones in Canada and the information reviewed, these side effects are considered rare.
  • Health Canada recommended that the safety information for all fluoroquinolone products be updated to include information about this rare but serious risk. 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. In addition, an Information Update and a Health Care Professional Letter will be published and distributed to further inform Canadians and healthcare professionals about this risk.
  • Health Canada is working with the Drug Safety and Effectiveness Network (DSEN) and the Canadian Agency for Drugs and Technologies in Health (CADTH) to conduct additional studies to better understand the use of fluoroquinolones in Canada.
  • On October 6, 2016, Health Canada brought together a Scientific Advisory Panel on Anti-Infective Therapies to discuss the risks associated with the use of fluoroquinolones. The panel recommended that the safety information for fluoroquinolones be updated, and risk communications be published and distributed to further inform Canadians and healthcare professionals about the potential risk that some of the known side effects, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders may be persistent and/or disabling.
  • Health Canada will continue to monitor safety information involving fluoroquinolones, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

As a result of its safety review, Health Canada is working on updating fluoroquinolone warning labels.

Additionally, above and beyond what the U.S. F.D.A. has done, Health Canada has agreed to publish and distribute a Healthcare Professional Letter regarding fluoroquinolone risks. The Healthcare Professional Letter includes the following points:

  • It is recommended that the potential for disabling and persistent serious adverse events be considered when choosing to prescribe a fluoroquinolone.
  • Fluoroquinolones should not be prescribed to patients who have experienced serious adverse reactions during or after prior treatments.
  • Healthcare professionals are advised to stop systemic fluoroquinolone treatment if a patient reports a serious adverse reaction. The patient’s treatment should be switched to an alternative treatment with a non-fluoroquinolone antibacterial drug if needed to complete the treatment course.
  • Healthcare professionals should be aware that some adverse reactions associated with the use of fluoroquinolones can occur within hours to weeks after exposure to the treatment.

This acknowledgement from Health Canada that fluoroquinolones may have permanent and/or disabling effects is a huge step in the right direction for Canadian “floxies.”

All Canadians who have experienced adverse reactions to fluoroquinolones are encouraged to report their reactions to Health Canada through the Canada Vigilance Adverse Reaction Online Database.

This acknowledgement from Health Canada is a huge step in the direction of safety and informed consent for all Canadians. It is appreciated!

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11 thoughts on “Fluoroquinolone Warning Labels to be Updated in Canada

  1. Eileen OBrien February 20, 2017 at 8:34 am Reply

    This is good news but not good enough and too late for thousands of victims…we are STILL dismissed by arrogant prescribers who REFUSE to believe we know something they DO NOT!!!…The unconscionable GREED of Bayer, Janssen and other pharmaceutical monsters will NEVER allow the fact that, for example, cipro alone ( just ONE of their products) made a profit of well over 2000 trillion american dollars about 10 years ago…IN A SINGLE YEAR!!!..PROFIT!!!!…Follow the money…the suffering and deaths WILL continue..I promise you..

    • Longtime Levaquin Sufferer February 20, 2017 at 2:51 pm Reply

      We need to email the White House en masse, every single day, hold Trump accountable, Google Margaret Hamburg indicted over Levaquin, she bribed Hillary and Obama with $100 million dollars to become the head of the FDA , Trump promised a special prosecutor for Hillary, Hillary and Obama made $100 million dollars from our deaths, The mass murdering goon, Hamburg has made herself more than a billion dollars from our death, none of their victims have been compensated, Trump is tied to the Rockafellers, and, Rothchilds, he is the New World Order, everyone of the criminals, mentioned in Hamburgs indictment have been well compensated for our mass murders, none of us have ever been compensated , enough is enough,We need to be vocal, and, loud, every damn day of our miserable, painful, and, hellish life, while we suffer to our deaths, at the hands of rich criminals,

      • Longtime Levaquin Sufferer February 20, 2017 at 2:53 pm Reply

        Also google, both of Margaret Hamburgs parents were former presidents of the American Eugenics Society,

    • Debs February 22, 2017 at 11:36 am Reply

      Sadly Eileen I have to agree with you .

  2. Lukasz February 20, 2017 at 6:41 pm Reply

    Health Canada doesn’t give a damn about drug safety or anyone who’s suffered an ADR, I submitted my report to the very website you posted and haven’t heard a beep from them. I guess they’re too busy pocketing bribed money from doctors and pharmaceutical companies alike.

    It sickens me that I have to suffer each and every day while these so called industry watchdogs engage in corruption of the worst kind. People say corruption exists only in third world countries, that’s the furthest thing from the truth. Corruption is alive and well right here in Canada.

    Health Canada can go to hell.

    • Lisa February 20, 2017 at 6:49 pm Reply

      A lot of people feel the same way about the FDA – and this decision from Health Canada was just modeled after the FDA decision, hearing, and label changes. These regulatory agencies aren’t doing their jobs sufficiently, for sure. But maybe, hopefully, these changes will save a life or two. If lives are saved, it is because of the advocates, not the failing agencies though.

      • Lukasz February 21, 2017 at 11:33 am Reply

        Their hand was forced because of the FDA changes otherwise they wouldn’t have acted in any way. But you’re right though, it’s the advocates (such as yourself) that are to be credited with saving lives, and not these devious agencies.

        The question is why do we not have any black box warnings on these drugs here in Canada? Is it because they don’t want us to know of the dangers associated with these drugs? Too much money at stake from their ties to Big Pharma?

        • Jason February 21, 2017 at 9:36 pm

          Yes, a shame, and a sham all at the same time, a review, and STILL no Black box warnings. Rare, my ass.

        • tammyrenzi February 22, 2017 at 6:14 am

          Jason, I agree. Whenever I mention my reaction to Levaquin, so many people know others who have suffered. It’s hardly rare. And when they haven’t heard, they write the names down so they don’t take them. No one would take these “medications” if they were truly warning people. (We also have to change the perception and belief that pills are a cure-all. That will take a huge shift in thinking…from, “I can eat burgers and fries. I’ll just pop a statin!” to a prevention frame of mind.)

  3. tammyrenzi February 20, 2017 at 7:08 pm Reply

    If it weren’t so cold up there, I might consider the move. Seriously, way to go Canada!!! This is great news.

  4. tammyrenzi February 20, 2017 at 7:12 pm Reply

    After reading Lukasz, I rescind my former post. I guess I’ll stay here.

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