DALLAS--(BUSINESS WIRE)--The Dallas-based national law firm of Baron & Budd, P.C., a leader in pharmaceutical litigation, has filed the first lawsuit involving a form of nerve damage known as peripheral neuropathy against pharmaceutical companies which marketed a class of powerful antibiotics called "fluoroquinolones" (FQs).
The most popular FQs, levofloxacin, moxifloxacin, and ciprofloxacin, are sold under the trade names, respectively, of Levaquin®, Avelox®, and Cipro®.
"FQs are one of the most heavily prescribed — and promoted — classes of antibiotics," said Baron & Budd Attorney Thomas M. Sims. "They are still frequently administered to deal with routine infections, although they have been implicated in a whole host of serious side effects."
Sims noted that last year the U.S. Food and Drug Administration (FDA), which had received numerous reports of peripheral neuropathy (PN) related to FQ use, ordered drug companies to change packaging inserts for all FQs to add a warning. The FDA had cautioned that damage from PN, which causes muscle weakness, numbness, and pain, could occur very soon after the administration of FQ drugs — and that damage could be permanent.
Now, one year after the FDA's August 15, 2013 announcement comes the publication of a study in the medical journal Neurology in which researchers have found that the use of oral FQs doubles the risk of developing PN among patients who have recently taken one of these drugs. This represents the first published epidemiological research to evaluate the risk of PN among patients who had been prescribed FQs. The study evaluated nearly one million male FQ patients aged 45 to 80 during the period from 2001 to 2011.
"Fluoroquinolones have become increasingly popular among physicians for the treatment of routine infections," Sims observed. "Pharmaceutical companies have heavily marketed fluoroquinolones to doctors as a cure-all. The unfortunate reality is that the best medical evidence clearly indicates the prescription of such potent antibiotics should be limited to the treatment of serious infections."
Sims noted that more than 23 million patients in 2011 (the last year for which figures are available) had received a prescription of an FQ antibiotic.
He also pointed out that the FDA warning about possible PN side effects in the use of FQs was not the first warning. "Actually, the FDA's 2013 order was an update to a 2004 label in which the manufacturers cautioned that peripheral neuropathy could be a side effect of this class of antibiotics," he said. "In the 2004 label, however, many of the manufacturers went on to note that there was no risk of permanent damage if the patient simply stopped taking the drug. Last year's order was handed down because the FDA determined that the manufacturers' existing label did not adequately warn physicians or their patients about the risk of permanent nerve damage."
In 2014 Baron & Budd began accepting cases involving Levaquin, Avelox, and Cipro. Baron & Budd founder Russell Budd noted that its initial case, which is believed to be the first-ever litigation against U.S. pharmaceutical manufacturers for FQ-induced peripheral neuropathy, was filed August 6, 2014 in San Francisco in the U.S. District Court for the Northern District of California. Other filings have since followed, he added.
"The study recently published in Neurology is validation for the many victims of fluoroquinolones who have struggled to be taken seriously and are now afflicted with severe and irreversible peripheral neuropathy," Budd said. "They took what they thought was a safe medicine. We hope this study puts a spotlight on the terrible damage that this class of drugs can cause."
"The tragedy is that so many of these plaintiffs could have been cured with a less risky antibiotic," Sims echoed. "But, because fluoroquinolones have been overpromoted for so long, people who turned to their doctors for the treatment of a simple sinus or urinary tract infection developed a far worse illness than the one they sought treatment for in the first place."
About Baron & Budd, P.C.
With a history of more than 35 years of "Protecting What's Right" for individuals, communities, and governmental entities, Baron & Budd, P.C., is devoted to making a meaningful difference in the lives of Americans. With law offices in Dallas, Austin, Los Angeles, and Baton Rouge, Baron & Budd is renowned for tackling complex cases in the litigation sectors of harmful drugs, dangerous medical devices, environmental contamination, financial fraud, and deceptive advertising.