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Fluoroquinolones Antibiotic Warnings are Insufficient Says FDA

May 16, 2016

The U.S. Food and Drug Administration's (FDA) antimicrobial drugs advisory committee and its drug safety and risk management advisory committee determined that the serious side effects connected to fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and basic urinary tract infections who may have other treatment options, reports FDA MedWatch.

Some serious side effects include tendon, joint and muscle pain, a "pins and needles" tingling or prickling sensation, confusion, and hallucinations. The FDA staff remarked that peripheral neuropathy has occurred in some patients when taking fluoroquinolones. Peripheral neuropathy is a condition caused by nerve damage that can cause weakness, numbness, and pain in the hands and feet, as well as other parts of the body, according to the Mayo Clinic.

Lyndsay Meyer, FDA spokeswoman confirmed the outcome of the FDA panel discussion. The results were: 21 to 0 voted that fluoroquinolone antibacterial drugs' labels do not have sufficiently strong warnings when used in the treatment of acute bacterial sinusitis; 18 to 2 voted that label warnings were not strong enough when used for the treatment of acute bacterial problems that complicate chronic bronchitis in patients with chronic obstructive pulmonary disease (COPD); and 20 to 1 voted that there are insufficient label warnings when the medication is used for the treatment of urinary tract infections (UTIs), Law360 reports.

In August, Bayer Corporation's Cipro was the subject of an injury suit filed in Pennsylvania. The plaintiff claims the warning label described the development of peripheral neuropathy from the use of Cipro as "rare," despite scientific evidence showing a clear link between the medication and the neuropathy. In September 2002, the plaintiff was prescribed Cipro, used it as directed and developed irreversible peripheral neuropathy, reports Law360.

Merck & Co., producer of Avelox, marketed and dubbed the "heir apparent to Cipro," Johnson & Johnson and Janssen Pharmaceutical's Levaquin, join the Bayer Corporation in similar lawsuits related to the recent FDA panel findings.

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