Suffering from injuries to his brain, nerves, and tendons for over four years, 45-year-old John Fratti of Hummelstown, PA, has taken on the Food and Drug Administration with good results. Since taking Johnson & Johnson’s antibiotic Levaquin for an infection he has had many diagnostic studies on his brain and body that show considerable damage. Healthy and athletic at 41 years of age, he now takes multiple prescription pain medications for his injuries.
On July 13, Fratti met with Karen Weiss, M.D., the lead for the Safe Use Initiative in the FDA's Center for Drug Evaluation and Research. The meeting included four other doctors and staff at the FDA White Oak Campus in Silver Spring, MD. “Levaquin should only be prescribed as the last line of defense for severe and life threatening infections,” Fratti told the FDA. Fratti presented his recommendations to the FDA doctors for their action. “The FDA should include information in the pharmacy leaflet that Levaquin has a black box warning and can cause irreversible pain and irreversible neurological damage. People deserve the right of informed consent," Fratti said. Several doctors at the FDA were so impressed with Fratti’s presentation that it was suggested he should get involved in the FDA Patient Representative Program while they consider his desires.