Levaquin Still a Threat, Victim Questions Impartiality of the FDA

Harrisburg, PAThis is a story primarily about Levaquin and Levaquin side effects, including Levaquin tendon ruptures and various other adverse reactions to the Levaquin medication. However an underlying theme is the ongoing criticism of the pharmaceutical industry and concern for how the US Food and Drug Administration (FDA) is funded.

John Fratti, who claims to be a Levaquin victim, appeared March 5 on WHP 580 AM in Harrisburg, and told the host that he has been disabled for nearly four years.

The Levaquin antibiotic lay at the root of his troubles. According to PDR Health, Levaquin is a fluoroquinolone antibiotic used to treat numerous types of bacteria that can affect the lungs, sinuses, skin and the urinary tract in adults. Under the heading, 'What is the most important information I should know about Levaquin,' the first sentence is striking: 'Serious and sometimes fatal allergic reactions have been reported in people taking Levaquin.' There is also reference to the possibility that long-term use of Levaquin could cause a second infection.

Adverse reactions to Levaquin have also included liver damage, together with pain, swelling and tears of the Achilles, shoulder or hand tendons.

The FDA responded last fall with a black box warning for tendon rupture, but is not considering the removal of Levaquin from the market because, in the FDA's view, the benefits continue to outweigh the risks.

Fratti questions the impartiality of the FDA. "The FDA has known about this for years," he tells the WHP host by phone March 5. "[FDA receives] approximately 50 percent of their funding directly from the pharmaceutical industry in what [are] called 'prescription drug user fees.' And that's an absurd conflict of interest."

The FDA's 'Patient Safety News' video release from October of last year opens with, "FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics…"

The FDA reminds that those at the highest risk for tendon rupture include people over the age of 60, patients who are taking certain steroids and individuals who have undergone transplants of the heart, lung or kidney. And while the Achilles tendon has been found to be most affected by Levaquin, other affected tendons include the rotator cuff, biceps, hand and thumb.

"And the risk isn't necessarily gone when the drug has stopped," says the co-host of FDA Patient News. "Cases have been reported in which tendon problems occurred up to several months after the drug was discontinued."

And there are other adverse reactions, says the FDA. "They're rare, but…they may include convulsions, hallucinations, depression, heart rhythm changes and serious allergic reactions."