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11 1,000th Patient T h e C aTa ly s T Online http://www. musc.edu/ catalyst
MEDICAL UNIVERSITY of SOUTH CAROLINA
Vol. 33, No. 31
Rx Warning: possible mitochondrial toxicity Watchdog group advocates for sterner warnings on antioboiotics Levaquin, Cipro By J. Ryne Danielson Public Relations
W
hen Raja Fayad, M.D., was murdered on the campus of the University of South Carolina this past February, he was working on something big, something Charles Bennett, M.D., Ph.D., hopes will be part of his legacy. Bennett is the SmartState endowed chair for medication safety and efficacy at the South Carolina College of Pharmacy, a partnership between USC and MUSC. Bennett also runs one of the largest and most successful pharmaceutical watchdog groups in the country, the Southern Network on Adverse Reactions — SONAR. In June and September 2014, SONAR filed two citizen petitions with the Food and Drug Administration regarding fluoroquinolones, a class of drug that includes the powerful antibiotics levofloxacin and ciprofloxacin — Levaquin and Cipro. Bennett wants “possible mitochondrial toxicity” and “serious psychiatric events” added to the drugs’ black box Bennett labels — the most prominent warning label required by the FDA. SONAR has gathered testimony from hundreds of patients who have experienced muscle weakness, chronic fatigue, cardiomyopathy, hearing loss, developmental disorders, severe depression or nerve damage after taking Levaquin and related drugs. A recent report from the FDA’s Office of Safety and Epidemiology has also linked neurodegenerative diseases like Parkinson’s, Alzheimer’s and amyotrophic lateral sclerosis (ALS) to quinolones and the mitochondrial toxicity reported by some patients after taking them. The problem: most patients – even most doctors
photo by Sarah Pack, Public Relations Powerful antibiotics Levaquin and Cipro, as well as other members of the flouroquinolone family, may be responsible for dangerous but unacknowledged side effects, including mitochondrial toxicity syndrome, a disruption of cellular function which causes severe nerve damage. – don’t know these side effects exist. On top of that, the most common use of the drugs is off-label, that is, for uses other than those explicitly approved by the FDA. Bennett gave an example: “A patient goes to see their doctor on a Friday afternoon because they don’t feel well. What we should do is watch that patient closely, see if they really have an infection; they probably don’t. The patient hates that. On the other hand, give them a prescription for Levaquin and they think, ‘my doctor's taking good care of me.’” The drugs are often prescribed, Bennett said, to placate patients — and doctors themselves. “The antibiotics are viewed as harmless and effective,” Bennett said. “So, why not write the prescription?” But, he stressed, the risk-benefit profile of quionolones, like all medications, is favorable only when the drugs are administered according to FDA–approved indications. Pharmaceutical companies are not allowed to market their drugs off–label, but doctors are allowed to prescribe drugs, including quinolones, for off–label use. Seventy–five percent of all prescriptions are written off-label, Bennett said. This presents problems when doctors are not fully aware of the possible side effects
READ THE CATALYST ONLINE - http://www.musc.edu/catalyst
See Wathdog on page 6