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Experts want stronger warnings on Levaquin, similar drugs

Two expert panels that advise the U.S. Food and Drug Administration agreed Thursday that the FDA needs to issue stronger warnings for Levaquin and for other so-called fluoroquinolone antibiotics due to their health risks.

The agency's Antimicrobial Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee came to that conclusion together after hearing testimony from the pharmaceutical companies, from people who have suffered from severe side effects and from others who attended the meeting held at the FDA's suburban D.C. campus.

The FDA doesn't have to do what the panels recommend, but it often does. In the meantime, anyone who has used Levaquin or another fluoroquinolone and who since has been diagnosed with a nerve condition known as peripheral neuropathy may call 1-866-LAW-2400 for a free consultation as to whether there is an entitlement to injury compensation.

Levaquin lawsuits and similar actions continue to be filed against the makers of this class of antibiotics. The litigation has been under way for some time now.

A panel of judges ruled in 2008 to centralize federal Levaquin lawsuits before a trial court in Minnesota in which the patients claimed that the drug "causes tendons to rupture" and "that defendants' warnings about this alleged side effect were inadequate."

The same panel made another key decision August, centralizing lawsuits against the makers of several fluoroquinolones in Minnesota again. The judges wrote in their Aug. 17 order, "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. These actions, in particular, focus on Levaquin (levofloxacin), Avelox (moxifloxacin), and Cipro (ciprofloxacin). Issues concerning general causation, the background science, regulatory history, and labeling will be common to all actions."


The FDA explained its instructions to the panel in a briefing packet. A part of it reads as follows: "We are asking the advisory committees to discuss the benefits and risks of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infections (uUTI). The fluoroquinolone antibacterial drugs currently available with one or more of these three indications are ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive)."

The FDA has taken fluoroquinolone safety measures in the last several years. Regulatory attention to the side effects of these antibiotics is nothing new. For instance, the FDA introduced a boxed warning "for tendinitis and tendon rupture in 2008," according to agency documents. Additionally, according to those same writings, the FDA enhanced its warnings and precautions "for the potential irreversibility of peripheral neuropathy in 2013."

So the patients are not making it up. The FDA looked at its own data on reported adverse reactions and concluded that something had to be done about fluoroquinolones. Thursday, the agency's own experts said that more stringent protections would be in order.

In the meantime, injured patients have been exercising their legal options. Some of them chose to let the experienced pharmaceutical injury attorneys at Reich & Binstock fight hard for their rights.

Fluoroquinolones are widely used in the United States. FDA figures have shown that about 33 million outpatient retail pharmacy fluoroquinolone prescriptions were issued to about 22 million patients in 2014.

The FDA further wrote, "Ciprofloxacin (Cipro) was the most commonly used fluoroquinolone during the [November 1997 through May 2015] study period, followed by levofloxacin (Levaquin). The vast majority of use was observed in adult patients aged 18 years and older. Females accounted for approximately two-thirds of the total patients who received a dispensed prescription for an oral fluoroquinolone in 2014."

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