The FDA – the largest regulatory agency in the United States – regulates $275 billion in pharmaceutical drugs. It is "responsible for protecting and promoting public health through the regulation and supervision of…prescription and over-the-counter pharmaceutical drugs. " and – according to its own web site – "ensure…the safety and effectiveness of all drugs…"
Considering this mandate to protect the American public and consumer, one would expect them to take all necessary measures to make those consumers – and prescribing physicians – aware of all risks associated with a medication; in this case, fluoroquinolone antibiotics. However, rather than send out Dear Doctor letters to physicians – a common and well-established method of communicating risks – the FDA instead buried information about risks in a press release.
On November 5, 2015, the FDA held a hearing on fluoroquinolone antibiotics. Thirty-five victims who became injured, disabled, or lost a loved one, came together and testified at the FDA to share their stories in an effort to increase and strengthen warnings so that what happened to all of us, will not happen to anyone else.
Based on scientific evidence, MedWatch reports, and patient testimony, an FDA advisory panel voted to change the warning labels to say that fluoroquinolone antibiotics are generally inappropriate for sinus infections, urinary tract infections, and bronchitis. It enacted these recommendations on July 26, 2016, strengthening warnings on fluoroquinolones.
This was a big win for the fluoroquinolone community and a testament to the tenacity of those of us who suffered injury and disability after taking Levaquin/levofloxacin, Cipro/ciprofloxacin, Avelox/moxifloxacin, and other fluoroquinolones. Yet despite recent FDA changes to the warnings on fluoroquinolones, that information was not reaching doctors, thereby leaving patients at great risk of the disabling adverse effects associated with these drugs.
While strengthened warnings are a big symbolic step, if those warnings are still not reaching doctors, then millions of their patients are still at risk. It is akin to the age old question, “If a tree falls in the forest, and no one is around to hear it, does it make a sound?” Well, if a pharmaceutical warning label is strengthened, and no one tells the medical community, do prescribing practices change?
While sending the Dear Doctor letters should be one of the FDA’s top priorities and primary responsibilities, these letters were never sent out. Therefore the Quinolone Vigilance Foundation has decided to write and send the letters ourselves to physicians across the country.
It is said, “Most activism is brought about by us ordinary people.” I believe that to be true. Those of us who have fought so hard to affect change never asked for this; we were thrown into activism because we were not warned about the risks of fluoroquinolones, and as a result, our lives are forever altered. We don’t want what happened to us to happen to anyone else. We are fighting a billion-dollar industry and waiting for the right people to do the right thing puts more patients at risk. Taking action steps in sending Dear Doctor letters, the Quinolone Vigilance Foundation is ensuring that the patient voice is heard.
We hope that by undertaking this endeavor, we can raise awareness of the dangers of fluoroquinolone antibiotics and protect the public from their adverse effects.
For more information about our work, fluoroquinolone antibiotics, and our Dear Doctor letter project, please visit us at www.SaferPills.org