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A drug watchdog group is asking federal regulators to put a new black box label warning on Levaquin, which would alert doctors and patients about the potential risk of mitochondrial toxicity from the antibiotic, which may be causing users to suffer a number of serious disorders.
The citizen’s petition was filed with the FDA late last week, according to a report by Law360.com, urging the drug regulatory agency to take immediate action strengthen the warnings provided with the Johnson & Johnson drug.
The petition indicates that information about the Levaquin mitochondrial toxicity risk should be placed prominently in a bold, black box on the label, which is the strongest form of warning the FDA can require a drug to carry. The group also indicates that the label should include information about the risk that mitochondrial toxicity from Levaquin may increase the risk of Alzheimer’s disease, Lou Gehrig’s disease, liver damage, and Parkinson’s disease.
The request comes from the Southern Network on Adverse Reactions (SONAR), from the University of South Carolina. It describes itself as a multidisciplinary pharmacovigilance initiative, whose goal is to reduce the time between the detection of adverse drug reactions and the medical community and FDA’s response to those reactions. The group conducts studies of adverse events reported to the FDA and other databases.
According to the petition, research by the FDA and others have linked all antibiotics belonging to the class known as fluoroquinolones, which includes Levaquin and Cipro, to potential mitochondrial damage. However, SONAR found that FDA’s adverse event database recorded a significantly higher number of complaints from doctors and patients involving Levaquin than with other drugs of the same class.
SONAR notes in its petition that mitochondrial toxicity manifests in a number of ways, and has likely been reported to the FDA as other potential Levaquin side effects, such as liver damage. The group estimates that mitochondrial toxicity could be the cause of as many as 31% of the nearly 80,000 Levaquin adverse events reported between November 1, 1997 and February 3, 2011. The group also notes that only between 1% and 10% of adverse events are estimated to actually be reported, suggesting the true extent of the problems may be substantially greater.
Stronger warnings about the risk of mitochondrial toxicity from Levaquin could lead doctors to consider using alternative antibiotics, according to the group. This could prevent consumers from suffering serious and potentially life-long complications, as well as reduce costs on the health care industry, Medicare and Medicaid.
According to the FDA, there are about 23.1 million patients who received a prescription for an oral fluoroquinolone in 2011. Cipro dominated the market, comprising 70% of those prescriptions, followed by Levaquin or a generic equivalent, which was used by 28%. Another 3.8 million patients received injections in 2011, with Levaquin or a generic equivalent making up 63% of those, followed by Cipro at 28%.
In July 2008, the FDA required that a “black box” warning be added about the tendon rupture risk with Levaquin and other fluoroquinolone antibiotics. However, the label update came at least two years after consumer advocates called for stronger tendon rupture warnings. The prominent consumer advocacy group Public Citizen filed a petition with the FDA in 2006, insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage.
Several thousand people throughout the United States who suffered a tendon rupture or other tendon damage after taking the drug subsequently pursued a Levaquin lawsuit against Johnson & Johnson, alleging that the drug maker withheld critical safety information about the drug by failing to update the warning label earlier.