Fda Changes Fluoroquinolones Labels

By Author: Devin Herz
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The U.S. Food and Drug Administration issued an alert Thursday to change warning labels of the popular prescribed drug Fluoroquinolones to add adverse side effects related to the drug while treating certain minor conditions.

The drug is used to treat bacterial infections and as immediate treatment for anthrax inhalation.

“The FDA is requiring label changes ... including an updated boxed warning and Medication Guide,” stated a press release from the FDA. “The serious side effects associated with Fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, Fluoroquinolones should be reserved for those who do not have alternative treatment options.”

Some of those side effects according to the release can lead to peripheral neuropathy.

“An FDA safety review has shown that Fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together,” stated the release. “These side effects can involve the tendons, ...
... muscles, joints, nerves and central nervous system. As a result, the FDA is requiring label changes for all systemic fluoroquinolone antibacterial drugs. The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of Fluoroquinolones and will keep health care providers and the public informed of new information.”

FDA press officer Theresa Eisenman said there was no exact date for the new labels to be utilized or what would happen to drugs already in the market with the older labels.

“This is the beginning of the safety label change process and some of the exact language may change before the labels are finalized,” she said. “The Sponsors will have an opportunity to respond to the labeling changes notification and engage in discussions with the Agency. FDA intends to complete the safety labeling changes process as soon as possible.”

Jennifer Norton, Senior Director of North America Communication Global Pharmaceuticals Communication and Public Affairs for Johnson and Johnson, and Janssen Global Services, LLC, manufacturers of the drug, said they are aware of the requirements.

“At Janssen, our first priority is the well-being of the people who use our medicines,” she said. “Levaquin (levofloxacin) is part of the important fluoroquinolone class of anti-infective prescription medications. We are reviewing the Drug Safety Communication and will continue to ensure our commitment to support the safe and appropriate use of fluoroquinolone antibiotics. Levaquin has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening.”

The Sill Law Group, an Edmond law firm, filed a lawsuit against two major drug companies in August claiming adverse effects in about 300 patients who suffered from peripheral neuropathy after using the drugs.

Dr. Tara Tabatabaie, a partner of the firm, said the FDA action was good news.

“This is a victory for consumers as too many individuals have suffered needless debilitating injuries as a result of being treated with fluoroquinolones for simple, uncomplicated infections, when less dangerous antibiotics have been available to successfully treat them,” she said. “Several of our clients testified in front of the FDA Advisory Committee in November, telling them about how their lives were ruined because of the injuries and side effects they suffered. We are very pleased to know that their pleas were heard by the Panel and the FDA. Hopefully the FDA’s action prevents similar injuries to many more patients.”

Her case ,which started in Stephens County, is now making its way through a federal court in Minnesota.

“As attorneys, we consider the FDA’s action as further support and confirmation of the claims we have brought against the manufacturers of these drugs, who have known about these problems for a long time and yet have done nothing to inform the public, the medical community, and the regulatory agencies of those risks,” said Tabatabaie. “Overall we certainly expect this action by the FDA to benefit the plaintiffs in the case.”

The FDA recommended in the release patients contact their doctors if they have any side effects and doctors to stop treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment.

I am Devin Herz, currently associated with Fulmersill. We believe everyone is equal under the law. We take pride in providing an unparalleled commitment to our clients, most of whom are individuals, families and small businesses who have been unfairly treated or tragically harmed by large corporations.