FDA Announces Safety Labeling Changing for Controversial Antibiotic

The FDA announced a new warning on labels for certain antibiotics you may be familiar with.

The drugs are called Fluoroquinolones and they have been found to cause serious side effects. On May, 12, the FDA said the antibiotic will now come with a warning stating the side effects outweigh the benefit of the drug for certain conditions.

The packaging will be changed to come with an updated boxed warning stating people getting treated for sinusitis, bronchitis, and uncomplicated urinary tract infections have other treatment options.

Packaging will also state that Fluoroquinolones like the brand names Avelox (moxifloxacin), Cipro (ciprofloxacin), and LEVAQUIN® (levofloxacin), should only be taken if you have a condition that prevents you from using an alternative antibiotic.

Fluoroquinolones are said to cause permanent, disabling side effects like Peripheral Neuropathy, and other conditions that effect the tendons, muscles, joints, nerves and central nervous system .

NBC Connecticut Troubleshooters spoke with a Connecticut woman last April who ended up with Peripheral Neuropathy, which she said lead to permanent nerve damage after she had taken Avelox for just a few days to treat Bronchitis with a lung infection.

“My life has slowed down, nothing is done quickly,” said Dorothy D’Amato. “My heart breaks, I can’t dance anymore.”

Dr. Ulysses Wu, an infectious disease specialist at St. Francis Hospital said some doctors like prescribing Fluoroquinolones because they treat a broad range of conditions but he urged caution.

“All warnings should make doctors think twice before they prescribe an antibiotic,” said Wu. “As an infectious disease doctor though, with any antibiotic, we should always think twice before we prescribe it.”

Bayer, which makes the drugs Avelox and Cipro, sent this statement to NBC Connecticut:

Bayer’s highest priority is the safety of patients who take our medicines. Cipro® (ciprofloxacin) and Avelox® (moxifloxacin) are both part of this important class of antibiotics, which has been used to treat a range of infections for many years. Bayer is carefully reviewing the information that FDA posted and will continue working with the agency on this topic.

We also reached out to Janssen, which makes the drug Levaquin, whose parent company is Johnson &Johnson, and they also sent a statement:

At Janssen, our first priority is the well-being of the people who use our medicines. 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 FDA said it will continue to review data about the safety of Fluoroquinolones and will keep both health care providers and the public informed of new information.

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