Rachel Brummert, executive director of the Quinolone Vigilance Foundation wrote a guest blog for Consumer's Union.
January 5, 2016
Guest post by Rachel Brummert, Executive Director, Quinolone Vigilance Foundation
Patients seeking relief from a sinus infection, uncomplicated urinary tract infection, or bronchitis should never become injured or disabled from medications that are supposed to help them.
But that is exactly what happens to millions of people worldwide when they are prescribed a powerful fluoroquinolone antibiotic like Cipro (ciprofloxacin), Levaquin (levofloxacin), or Avelox (moxifloxacin) for routine infections which do not need their strength and for which there are safer alternatives.
Fluoroquinolones are a class of broad spectrum antibiotics that are incredibly powerful with the capability to save lives when used appropriately as a treatment of last resort for life-threatening bacterial infections like anthrax. But these antibiotics also have equal power to destroy lives when they are inappropriately prescribed for routine infections, which don’t need their strength. Prescribing an antibiotic strong enough to treat anthrax for a simple infection is like detonating an atomic bomb to kill a mosquito. Fluoroquinolone antibiotics are associated with severe adverse reactions, which may be permanent and life-threatening.
As the number of prescriptions for fluoroquinolone tablets, IV, eye drops, and ear drops have increased, so have the number of adverse reactions reported to the FDA. These adverse reactions encompass several body systems including the peripheral, autonomic, and central nervous systems, psychiatric, cardiovascular, musculoskeletal system, and more.
The FDA is taking notice of this. The agency has issued a “black box” warning to prescribers of the drug. And in a recent review, the FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.
That is exactly what happened to me. I went to my doctor for treatment of a routine sinus infection and instead I was inappropriately prescribed an antibiotic that has disabled me. According to the CDC, up to 50% of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed.
On November 5, 2015, I was honored to testify at the FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The panel discussed the risk/benefit ratio of fluoroquinolone antibacterial drugs for the treatment of routine infections. I shared my story of how I was an otherwise healthy individual who was prescribed Levaquin for a routine sinus infection in 2006 and became disabled with ten tendon ruptures, peripheral neuropathy, cardiac problems, and a progressive neurodegenerative disorder from which I will never recover. My sinus infection would have resolved had I been prescribed a safer alternative and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury.
The hearing took place at the FDA White Oak Campus in Silver Spring, Maryland, the same building and conference room as the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Hearing on March 27, 2015 at which I testified about how the Pliva v Mensing Supreme Court decision prevents victims harmed by generic fluoroquinolones from pursuing legal action against their makers and how patients are being harmed unnecessarily because generic drug makers are not required to update the safety information on generic drugs.
At the November FDA hearing, 35 people, including me, testified in front of the twenty-one member FDA advisory panel, each sharing their emotional, gut-wrenching stories of how fluoroquinolone antibiotics caused them, or someone they love, irreparable harm. Among them was a woman who lost her son, a man who lost his brother, and dozens of victims who once led healthy, productive lives and can no longer enjoy a reasonable quality of life.
The advisory panel agreed that the risks outweigh the benefits when fluoroquinolone antibiotics are inappropriately prescribed for routine infections and they voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis.
Advocating for victims of fluoroquinolone antibiotics, promoting patient safety, educating patients and the medical community, and engaging in research is our primary goal at the Quinolone Vigilance Foundation, and we applaud the FDA advisory panel for taking steps in the right direction to protect patients from preventable harm. By recommending limiting fluoroquinolone antibiotics to life-threatening infections and not prescribing them for routine infections, patients will be protected from life-long injury and disability, and it will help combat antibiotic resistance, a growing world-wide epidemic. These are steps in the right direction because a preventable problem is a fixable problem.