FDA Failed to Warn Public of Serious Side Effect Linked to Antibiotic Levaquin

FDA Failed to Warn Public of Levaquin Side Effect

FDA Failed to Warn Public of Levaquin Side Effect

The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report.

In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report that raises concerns about possible “mitochondrial toxicity” associated with fluoroquinolones, which are marketed under brand names including Levaquin and Cipro and the generic form levofloxacin. These powerful antibiotics have been used to treat anthrax cases and are used for pneumonia and kidney infections.

Since 2008, fluoroquinolones have carried a black box warning, the FDA’s most serious drug label warning, to alert doctors to side effects including ruptured tendons and nerve damage. ABC5 obtained an FDA database of adverse effects and found 3,000 deaths and 200,000 complaints of serious effects associated with Levaquin and similar drugs.

Cindy Rapkin is among those who experienced serious side effects with Levaquin, ABC5 reports. She stopped taking the drug after developing vision problems and sore tendons. “I was having such horrible, horrible pain, my knee was killing me,” said Rapkin. Karen Paddock had so much pain she was needed to use knee pads and wooden board on rollers to move around, her husband said. Karen Paddock took her own life, because of “an accumulation of the various pains from that [Levaquin] and other health conditions that pushed her over the edge,” according to Bob Paddock.

The FDA has not disclosed its findings about mitochondrial toxicity, according to ABC5. Symptoms of mitochondrial toxicity include muscle weakness, peripheral neuropathy (numbness of fingers and toes), and pancreatitis. The most severe symptom is lactic acidosis, in which a build-up of lactic acid in the tissues leads to loss of energy, organ failure, and eventually death. According to the Mayo Clinic, the most common organs to experience damage are the brain, heart, liver, muscles, kidneys and the endocrine system.

Dr. Charles Bennett, a drug safety advocate who holds an endowed chair in Medication Safety and Efficacy at the Centers of Economic Excellence at the University of South Carolina, has been studying the side effects associated with Levaquin and similar drugs for a number of years. While Bennett does not recommend removing fluoroquinolones from the market, he calls for increased warnings about the side effects. Bennett says, “Mitochondria are the gas tank, mitochondria toxicity means there’s no gas in the tank and your body really cannot function.”

Bennett filed a citizens petition with the FDA in June 2014, urging additional warnings based on the 2013 report on mitochondrial toxicity. The FDA did not add the warning and notified Bennett that it had “been unable to reach a decision” and would continue to study the issue. Bennett says the review could take years and delays could cost additional lives. Reporting drug side effects to the FDA is voluntary and Bennett argues that the only about one percent of adverse events are reported. If Bennett is correct, based on the 3,000 deaths acknowledged in the 2013 FDA report, the actual number of death may be closer to 300,000, according to ABC5.









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