WASHINGTON, Sept. 15, 2016 /PRNewswire/ -- It was announced yesterday that Hillary Clinton, presidential candidate, is taking ten days of the antibiotic, Levaquin, to treat a mild case of pneumonia. http://www.usatoday.com/story/news/politics/elections/2016/09/14/hillary-clinton-campaign-medical-records/90369052/
This is deeply concerning given that July 26, 2016, the FDA announced that "Fluoroquinolones, including Levaquin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: Tendinitis and tendon rupture, Peripheral neuropathy, Central nervous system effects." (FDA website, http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf)
Under the heading "Central Nervous System Effects" on the Levaquin label, it states: "Fluoroquinolones, including Levaquin, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, toxic psychoses, increased intracranial pressure…. Fluoroquinolones may also cause… tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose…."
Furthermore, the Levaquin label states, "These reactions can occur within hours to weeks after starting Levaquin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions."
January 2016, Larry Klayman, attorney for five Plaintiffs damaged by Levaquin, filed a lawsuit against former FDA Commissioner Dr. Margaret Hamburg; her husband, Peter Brown, and Robert Mercer, Co-CEOs of Renaissance Technologies; James Simons, Renaissance Technologies Chair; and Johnson & Johnson (J&J), the maker of Levaquin. While Dr. Hamburg was FDA Commissioner, Renaissance Technologies hedge fund held as much as half a billion dollars in J&J stock. (Case No. 1:16-cv-00086, U.S. District Court for the District of Columbia)
Because Renaissance Technologies held as much as $3 billion in drug company stocks, this lawsuit claims that Dr. Hamburg and her husband violated the conflict of interest statute that "bars a Federal employee from participating personally and substantially… in any particular matter in which the employee has a financial interest. These restrictions also apply regarding the interests of an employee's spouse.…" (FDA website)
An estimated 5,000 people died and an estimated 80,000 people were damaged after consuming Levaquin without adequate safety warnings while Dr. Hamburg was FDA Commissioner and her husband was Renaissance Technologies Co-CEO.
It wasn't until after Dr. Hamburg left the FDA that the warnings of disabling and potentially irreversible serious adverse reactions, described above, were added to Levaquin.
Klayman questions, "Although the warnings are now on the Levaquin label, why would Clinton's physician prescribe these dangerous antibiotics to a presidential candidate? Why would a physician subject a presidential candidate to an antibiotic that could result in permanent neurological or psychiatric issues?"
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SOURCE Larry Klayman