Risk for permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection

ADR BULLETEIN

Risk for permanent nerve damage from antibacterial   fluoroquinolone drugs taken by mouth or by injection

                               Fluoroquinolones are Antibacterial drugs approved for the treatment or prevention of certain bacterial infections. Peripheral neuropathy is an identified risk of fluroquinolones and was added to the Warnings or Warnings and Precautions sections of all the labels for systemic (oral and injectable) fluoroquinolone drugs in 2004.

                               FDA has continued to receive reports of peripheral neuropathy even after the adverse reaction was added to the fluoroquinolone drug labels. The results of FDA’s recent review of the Adverse Event Reporting System (AERS) database indicate that although the risk of peripheral neuropathy is described in the drug labels of each marketed systemic fluoroquinolone, the potential rapid onset and risk of permanence were not adequately described. The recent AERS review evaluated cases of fluoroquinolone-associated peripheral neuropathy with an outcome of “disability,” reported between January 1, 2003 and August 1, 2012.

                              The review showed a continued association between fluoroquinolones use and disabling peripheral neuropathy. However, because AERS is a spontaneous reporting system, an incidence of peripheral neuropathy, especially permanent damage among patients exposed to these medications, cannot be calculated. The onset of peripheral neuropathy after starting fluoroquinolone therapy was rapid, often within a few days. In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.

                                The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin, ciprofloxacin, moxifloxacin, norfloxacin, ofloxacin, and gemifloxacin. The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to cause this risk.

                                If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Peripheral neuropathy is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent. Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.        

                     

 Additional Information for Patients

• If you are taking a fluoroquinolone drug by mouth or by injection, know that it may cause symptoms in the arms or legs such as pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature . These symptoms can occur early in treatment and may be permanent.

• Contact your health care professional right away if you take a fluoroquinolone drug and experience any of the above symptoms; it may be necessary to stop the fluoroquinolone and take another antibacterial drug, but do not do so without first talking with your health care professional.

• Carefully read the Medication Guide that comes with your fluoroquinolone prescription.

• Discuss any questions or concerns about fluoroquinolone drugs with your health care professional.

• Report any side effects you experience to your health care professional   

                          

 Additional Information for Health Care Professionals

• Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy.

• Make sure your patients receive the Medication Guide with every prescription.

• If the patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped and an alternative non-fluoroquinolone antibacterial drug should be used, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.

• Report adverse reactions involving fluoroquinolones .

Shinu.C
Sr Lecturer