Dr. Charles Bennett is 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 Carolina.
"People's lives, people's livelihood, the economy - all are at risk," said Bennett.
Bennett has been following the side effects associated with Levaquin and similar drugs for years and is not advocating removing the drugs from the market, but instead increased warnings to ensure both doctors and patients are more fully aware of side effects.
"To put it in plain language," said Bennett. "Mitochondria are the gas tank, mitochondria toxicity means there's no gas in the tank and your body really cannot function."
But instead of acting, the FDA notified Bennett that it's "been unable to reach a decision" and will continue to study the issue.
In response to our report, the FDA said it "cannot discuss ongoing drug investigations," but did say, "it takes concerns" we raised "seriously" and is "considering the matters raised by the petition and is giving it careful consideration."
Even so, Bennett says the FDA's review could take years and delays could cost additional lives.
"The FDA gets about one percent of all reports," said Bennett, who argues if you take the 3,000 deaths already reported, the actual number of deaths is closer to 300,000.