Fratti should know. In four years, the former pharmaceutical company rep has devolved from an athletic 41-year-old to a middle-aged man wracked with pain and in need of multiple medications to treat and combat his injuries.
"Levaquin should only be prescribed as the last line of defense for severe and life threatening infections," Fratti told the FDA.
Participants in the meeting on July 13 included Dr. Karen Weiss, the lead for the Safe Use Initiative in the FDA's Center for Drug Evaluation and Research, and four other doctors and staff at the FDA's White Oak Campus in Silver Spring, Maryland.
Fratti's war on levaquin included a plea to the FDA to "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."
CBS 8 of San Diego reported that after Fratti filed of request under provisions of the Freedom of Information Act, he discovered that the FDA had received 14,786 individual safety reports related to levaquin medication, with the total number of death outcomes by case for Levaquin at 1,015. "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 meetings with staff within the Office of the Attorney General for Pennsylvania, congressional offices, and numerous doctors.
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Adverse reactions for Levaquin include tendon ruptures, which can not only severely limit or quell a person's ability to participate in sport or exercise, but can also impact an individual's movement. The FDA reports that the risk for levaquin-related tendon problems can increase for the elderly and especially for those receiving concomitant corticosteroids. Even worse, torn tendons (tendon rupture) can occur not only during active levaquin therapy, but also after the levaquin has stopped.
Fratti has been featured in a number of documentaries and has gone from a career recommending and selling medications to warning against a medication he never suspected would put him in the spot he is in.