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FDA issues warning on common antibiotics

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  • FDA issues warning on common antibiotics

    I generally don't think the medical community does as good a job as they could educating patients about the drugs prescribed. Recently, the FDA put out a warning to use fluroquinolone (levofloxacin) antibiotics only if no other treatment options exist because of the potential ill effects, including cns and musclo skeletal damage. It is particularly dangerous if over 60 or uses NSAIDs or cortisteroids.

    [ 7-26-2016 ] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.
    We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
    Last edited by Suebee; 09-19-2016, 04:17 PM. Reason: To add link

  • #2
    Is it just the one antibiotic?


    • #3
      Scary sounding stuff!!


      • #4
        I couldn't find a reliable source listing the names of antibiotics which fall in this class, so I only listed the one I was prescribed a few days ago for sinus / upper rep infection - levofloxacin. I got 3 1/2 pages listing warnings from pharmacy when I picked up med but I initially ignored it because I was desperate to feel better and wrongly assumed that my practitioner considered my mS. After I took the first dose, however, I was extremely dizzy and then later too weak to walk around house. I also had significant gastro distress. Dr Google came to the rescue, informing me that the side effects are so significant and possibly permanent that the FDA issued the above warning about 3 weeks ago. I think it is dangerous to encourage fear mongering- this medicine obviously has an appropriate time and place, especially if you are allergic to penicillin or have antibiotic resistant infection. I did not. But I have had my share of cortisteroids, eat NSAIDs like candy, and have a significantly damaged cns. This medicine shouldn't have been prescribed to me. Mr dr is good, I think there are too many prescriptions with too many warnings that a serious so called "black box" warning for this type of antibiotic got lost in the fray. I really think the medical community could do a better job educating themselves and us patients about appropriate uses of particular Pharmasuticals. In that regard, pharmaceutical sales people could serve an important public protection role by pointing these things out. Just saying.


        • #5
          Next time, ask your pharmacists if there could be problems. They're trained for this - doctors generally aren't. My local pharmacists have saved us from serious drug interactions, and helped fix insurance problems, as well. Also, "WorstPills," a site belonging to Public Citizen, is a good resource for potential problems. Like Consumer Reports, they take no advertising or corporate support. Some of their info is free; more detailed reports can be obtained with an annual subscription (~$30). Check them out online. You can also see if your medication has been limited or banned in other countries. Europe and Canada tend to be stricter than the US.


          • #6
            I second what Celia said. Pharmacists are pretty knowledgeable about meds. They do a significant amount of schooling on it anyway.

            Sorry Suebee that this has happened to you. Have you talked to your doctor about it yet?


            • #7
              I relayed a message via asst to the Physician's assistant, which means it is a real game of telephone.

              I understand why the PA/Dr model is becoming the norm in the states but as this is my only platform for voicing public policy concerns for MS--- creating more levels between the actual dr and patient isn't going to increase quality of care and it seems questionable if it really reduces the cost of delivery. Isn't this true especially for people with MS, who have more complexities re health than the average person? This is why some urban cities are seeing "Boutique" drs - doctor's you pay a yearly fee to be one of their patients. A shame that medicine is getting striated for the classes. ( Maybe I would like idea better if I had money to get a Boutique dr! half joking.) Maybe doctors should be paid what it really costs for a office visit by insurance and not have to resort to using less expensive staff in order to pay the rent and feed themselves. (Not sure if that is real the reason behind PA/ dr model, but i took a stab at it.)