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The United States: FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
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, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. FDA also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections. FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive).

FDA has 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.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone. FDA evaluated only reports submitted to them, so there are likely additional cases of which they are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time they received the reports the side effects had continued for an average of 14 months, to as long as 9 years, after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

In addition to updating information in the Boxed Warning, FDA is also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for ABS, ABECB, and uncomplicated UTIs. The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. FDA is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.

Patients are advised to contact their health care professional immediately if they experience any serious side effects while taking fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations.

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Please refer to the following website in FDA for details:

In Hong Kong, there are 249 registered pharmaceutical products which are fluoroquinolone antibacterial drugs, including ciprofloxacin (106 products), levofloxacin (66), ofloxacin (53), moxifloxacin (9), norfloxacin (11), lomefloxacin (2), prulifloxacin (1) and sparfloxacin (1). All these products are prescription only medicines. Related news was previously issued by the US FDA, and was posted on the Drug Office website on 13 May 2016. Letters to local healthcare professionals were issued on the same day to inform them of restricting fluoroquinolone antibiotic use for certain uncomplicated infections. So far, the Department of Health has received one adverse drug reaction case (ADR) in connection with levofloxacin, but it was not related to the serious side effects mentioned in the above announcement. No ADR report has been received for the other fluoroquinolone drugs. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.

Ends/ Wednesday, July 27, 2016
Issued at HKT 14:00
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