A recently uncovered 2013 Food and Drug Administration report found serious warnings about the antibiotics Levaquin, Cipro and the generic form Levofloxacin, which raises new concerns about possible “mitochondrial toxicity” — the disruption of cell function.

A recently uncovered report on popular antibiotic side effects raises raises new concerns about possible “mitochondrial toxicity” — the disruption of cell function.

The FDA failed to disclose additional serious side effects of the drugs, KGTV-San Diego reported.

Levaquin, Cipro and Levofloxacin are part of a family of antibiotics known as fluoroquinolones. These antiobiotics are popular drugs in this class and are used frequently to treat Community Acquired Pneumonia, kidney infections, and even anthrax cases.

KGTV obtained a 2013 FDA report showing that at least 3,000 patients had died and that there were 200,000 complaints of serious side effects associated with Levaquin and this class of drugs. The most common side effect is ruptured tendons – especially the Achilles tendon, rotator cuff, biceps, hands and thumbs.

But another physician, Dr. Charles Bennett, a drug safety advocate with the University of South Carolina Center of Economic Excellence, said that the FDA gets only about one percent of all reports of death, and the actual number of deaths is closer to 300,000.

The actual number of deaths may be closer to 300,000.

It appears the FDA kept a lid on the report. Even after Dr. Bennett challenged the FDA and urged additional “black box” warnings based on the FDA’s own 2013 report, the agency said it hadn’t made a decision on the drug. A black box warning is the strictest warning in the labeling of prescription drugs. It’s used when there is reasonable evidence of an association of a serious hazard with the drug.

It appears the FDA kept a lid on the report despite recommendations from some in the medical community for additional “black box” warnings.

Weighing the Odds
An emergency room physician interviewed for this article who asked to remain anonymous said that while he had not heard of the 2013 report, physicians have known for some time that this class of antibiotics has side effects, which doctors often tell patients prior to prescribing. “Some physicians actually document this conversation similar to any risk/benefit discussion,” the doctor said.

“One side effect of fluoroquinolones may cause tendon ruptures,” he explained. “Cipro (Ciprofloxacin) and Levaquin (Levofloxacin) are popular drugs in this class and are used frequently, for many things.”

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The ER physician, who works in a large medical group, shared other concerns.

The KGTV story highlighted two cases of individuals with very serious side effects. However, “the problem is often these reports are dealing with very sick individuals who may have died anyway,” the physician explained. “I wonder what the case is here for these antibiotics,” he said.