45-year-old Hummelstown patient takes on FDA over Johnson & Johnson’s antibiotic Levaquin

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.

Recently, Fratti filed a Freedom of Information Act request with the FDA for information concerning Levaquin. The FDA report states that 14,796 individual safety reports have been filed and the total number of death outcomes by case for Levaquin is 1,015. Fratti filed a law suit against Johnson & Johnson last year. “I’m trying to warn everybody that I can about the dangers of Levaquin and its delayed toxicity,” Fratti said. His advocacy efforts have included meeting with the Pennsylvania Attorney General’s staff, congressional offices, and numerous doctors.

Fratti was filmed in a documentary on Levaquin at www.Certainadverseevents.com  The film, Certain Adverse Events, is currently winning awards at various film festivals across the country. Fratti has recently been filmed in two other forthcoming documentaries, one a BBC documentary and another one that covers Levaquin for the Korean Broadcasting System.  Fratti, who has a master’s degree, formerly worked as a pharmaceutical sales representative for over seven years.