Levaquin - John Fratti and the FDA
In most of the Levaquin cases brought up so far, the information has revolved around lawsuits that have been filed by various patients affected by the dangerous antibiotic against manufacturers Johnson and Johnson. A new discussion has been opened up, however, that is taking a distinctly different approach. Forty-five-year-old John Fratti, a former Levaquin patient, has directly engaged the Food and Drug Administration to discuss what he considers inadequate efforts on J&J's part to fully inform people about Levaquin's black box warning pertaining to joint injuries and tendon ruptures.
Fratti's prescription of Levaquin has left him in significantly reduced health compared to just 4 years ago. Once reasonably fit, he now has to take numerous prescription painkillers to manage the pain from his injuries. There is even evidence to suggest that he suffered partial brain damage from the medicine. Thus, if anyone has a case to bring, it is Mr. Fratti, and to be sure he did file a lawsuit against the makers of Levaquin last year.
However, he isn't restricting his approach to the reparations he intends to receive from Johnson and Johnson. He recently made a formal presentation to the FDA about the nature of Levaquin's effects on his life, and the lack of information available about the dangerous side effects of this antibiotic. He stressed a desire to see the information pamphlet included with Levaquin contain more information about the black box warning and just what the warning means.
Showing that unusual approaches and out-of-the-box thinking can have a positive effect, the FDA stated that they were impressed with Mr. Fratti's arguments, and recommended he work with the FDA's Patient Representative Program. They also stated that they were definitively looking into his concerns and intended to address them directly, in the best way they could manage. This is an encouraging sign for people who have the intent and the skill to organize their resources and get the word out about Levaquin's true side effects.
