The FDA approved label changes for fluoroquinolones, a class of antibiotics that are associated with disabling side effects that can be permanent.
The authorities recommend limiting the use of fluoroquinolones in patients that had less severe bacterial infections.
Furthermore, the risks and benefits of this type of antibiotics should be careful taken into consideration. The FDA stresses the fact that both doctors and patients have to be aware of the effects of the antibiotics in order to make a correct decision, adapted to the situation.
Fluoroquinolones are used to kill and stop the growth of bacteria. They are also very efficient in treating severe infections.
The FDA safety review discovered that the oral and the injectable medicine could produce disabling effects to muscles, joints, and tendons, to nerves and the central nervous system.
The side effects can appear in a matter of hours or days after the treatment. Some of the effects are permanent.
The FDA recommends not using this class of antibiotics on acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated urinary tract infections.
The fluoroquinolones should, however, be used in plague, anthrax, and bacterial pneumonia and other severe bacterial infections.
The medicines include levofloxacin, which is marketed as Levaquin, the ciprofloxacin contained by Cipro, the moxifloxacin from Avelox products, ofloxacin and the gemifloxacin sold under the name of Factive.
The new label will have an updated boxed warning and new indications in the precautions section, mentioning the risk of disabling adverse reactions that can be irreversible.
The notice will contain the list of conditions that should be treated with the antibiotic and also a list of the diseases that do not necessary require its use.
Moreover, each patient that follows a fluoroquinolone treatment will receive a Medication Guide containing a full description of the medicine and the side effects associated with its use.
The FDA issued a warning ever since 2008 when the risks of tendinitis and tendon rupture were listed on the label. In 2011, the notice added increased dangers for people with myasthenia gravis, and in 2014 the FDA added irreversible peripheral neuropathy.
The recent updates are the result of a study performed in November 2015, when the agency decided on the categories of the disease which should be treated with the antibiotic.
The conclusion is that, due to its irreversible secondary effects, fluoroquinolone should only be used when no other treatment is available.
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