The FDA is Failing to Notify the Public About a Serious Side Effect Caused by Levaquin

The FDA is Failing to Notify the Public About Levaquin
The FDA is Failing to Notify the Public About Levaquin

The FDA is Failing to Notify the Public About Levaquin
The FDA is Failing to Notify the Public About Levaquin

The U.S. Food and Drug Administration (FDA) is failing to inform the public about dangerous side effects associated with Levofloxacin (brand names Levaquin and Cipro), an antibiotic in the fluoroquinolone family that is one of the most popular and widely prescribed drugs on the market.

Levaquin and other fluoroquinolones are used to combat serious infections such as pneumonia and kidney infections, and are used to fight anthrax. According to a 2013 FDA report obtained by ABC5 in Cleveland, Ohio, the drugs can cause “mitochondrial toxicity,” but the federal government is not disclosing this information to the public.

In 2008, the FDA put a black box warning on Levaquin’s label warning doctors that the drug can cause ruptured tendons and nerve damage. ABC5’s investigation uncovered 3,000 deaths and 200,000 complaints of serious adverse events caused by the antibiotic in an FDA database.

Mitochondria are the cells’ “power plant.” They use oxygen, fat and sugar to produce adenosine triphosphate (ATP) – a process known as “cellular respiration.” When cells need energy, they break down energy molecules of ATP to release the stored energy. Mitochondrial toxicity is damage that decreases the number of mitochondria. Cells can stop working properly if they have too few mitochondria, resulting in muscle weakness (myopathy) and lactic acidosis, explains.

“To put it in plain language,” said Dr. Charles Bennett, a drug safety advocate and serves as the Endowed Chair in Medication Safety and Efficacy for the Center of Economic Excellence at the University of South Carolin. “Mitochondria are the gas tank, mitochondria toxicity means there’s no gas in the tank and your body really cannot function,” Dr. Bennett told ABC5.

Dr. Bennett filed a petition with the FDA in 2014 urging additional warnings based on the agency’s 2013 report, the same one that was obtained by ABC5, concerning mitochondrial toxicity. The FDA notified Dr. Bennett that federal health regulators had “been unable to reach a decision” and will continue to study the issue.

According to Dr. Bennett, it could take the FDA months, if not years, to reach a consensus, and many more people could die in the meantime.

“The FDA gets about one percent of all reports,” Dr. Bennett told ABC5. He argues that if you take the 3,000 deaths already reported, the actual number of deaths is closer to 300,000.