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FDA expert committee to meet on antibiotics safety


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Determined to get to the bottom of health problems seemingly related to the ingestion of fluoroquinolone antibiotics, the U.S. Food and Drug Administration announced that two of its expert committees will hold a joint meeting about these medications that will be open to the public. The meeting will be held Nov. 5 from 8 a.m. to 6 p.m. at the FDA’s Silver Spring, Md., campus.

One panel advises the FDA about antimicrobial drugs and the other has the agency’s ear when it comes to drug safety and risk management. Each is expected to make safety recommendations.

The fluoroquinolone class of antibiotics includes the following drugs:

  • Avelox
  • Cipro
  • Factive
  • Floxin
  • Noroxin

“The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions,” according to the FDA’s Oct. 1 announcement.

Based in large measure on recent medical science, patients have filed fluoroquinolone lawsuits against the makers of these drugs. They allege a connection between the use of the drug and the risks of conditions ranging from tendinitis and tendon rupture to irreversible nerve damage.

A panel of judges in August centralized federal fluoroquinolone lawsuits before one court for pretrial coordination, ideally to economize the time that the court, parties, witnesses and so on must devote to all of these cases. Centralization also is intended to preclude inconsistency in pretrial rulings among the cases.

“These actions share common factual questions arising out of allegations that oral and injectable fluoroquinolone antibiotics cause or substantially contribute to the development of irreversible peripheral neuropathy and that the warnings provided by defendants concerning that risk were inadequate,” the federal judges wrote in their August order that transferred numerous fluoroquinolone lawsuits, centered on nerve damage, to a federal trial court in Minnesota. “These actions, in particular, focus on (levofloxacin), Avelox (moxifloxacin), and Cipro (ciprofloxacin). Issues concerning general causation, the background science, regulatory history, and labeling will be common to all actions.”

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There may be people who are skeptical about the claims that plaintiffs in fluoroquinolone lawsuits are making. Well, the skeptics do not include the U.S. Food and Drug Administration.

Not only has the FDA called for upcoming expert panel discussions on the safety of these antibiotics, it has required fluoroquinolone drug labels to be modified to reflect recent findings about risks to patient health – risks that allegedly the manufacturers of those drugs should have known about and should have taken immediate steps to minimize.

The FDA in August 2013 announced that drug labels and medication guides for fluoroquinolone drugs would be revised to describe the risk of peripheral neuropathy, which “may occur soon after these drugs are taken and may be permanent.”

The agency explained back then, “The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.”

The FDA described PN as follows: “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.”

If you took a fluoroquinolone antibiotic and were since diagnosed with peripheral neuropathy, perhaps you would be entitled to compensation for medical expenses, disability and other losses. Talk to a lawyer, ideally one experienced in pharmaceutical injury litigation, to determine what your legal options are. The experienced attorneys at Reich & Binstock offer a free consultation.

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