Charles Bennett MD PhD Chair of the Center for Economic Excellence in Medication Safety and Efficacy, University of South Carolina will be speaking at the PharmedOut’s 5th Annual Conference on June 11-12, 2015 at Georgetown University about Fluoroquinolones.
To see a list of speakers click here.
PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices. PharmedOut promotes evidence-based medicine by providing slideshows, videos, events, and links to pharma-free CME courses.
Should black box warnings for fluoroquinolones be revised: Is the bar set too high? Charles Bennett MD PhD, University of South Carolina The Food and Drug Administration (FDA) has received >150,000 reports of adverse events and 2,400 reports of deaths associated with the generically available levaquin and ciprofloxacin (two of the three FDA-approved fluoroquinolone antibiotics). Almost half of these reports are associated with psychiatric and neurologic toxicity. The current Black Box label warns of tendonitis, tendon rupture risks, and neurotoxicity occurring among persons with myasthenia gravis; Current product labels provide variable information on psychiatric toxicities.
The Southern Network on Adverse Reactions (SONAR) has been investigating these questions for four years, using a novel multi-pronged approach that includes animal studies and, in collaboration with persons who have self-reported quinolone toxicity, a review of FDA adverse event reports.
Is it time for a revision of the Black Box warnings?
Thank you
Thank you Dr. Bennett for being a courageous champion in the fight to bring the truth about the Fluoroquinolone antibiotics to the world.
I was healthy as horse and strong as a bull until 2014 when I got a unary tract infection. When an ignorant urologist doctor ordered by phone Levaquin for me without any discussion with me about its adverse side effects. An office person relayed that he had ordered a prescription, “take it”. The pharmacy, Rite Aid, Brookhaven, GA did not use “Black Boxes” so I was totally unaware of the adverse side effects. I now have poor control & weak legs & arms, was diagnosed with enlarged Aorta, Periphereal Neuropathy, significantly diminished hearing, significantly diminished eyesight, stiff & painful back, fatigue. All of these conditions I will have to live with until death because of one careless doctor. The Levaquin did not give me any UTI relief. I requested a sulfur drug from my retired doctor of 42 tears. He gave me SMZ-TMP. I complete relief from UTI in 2 days. I had a UTI condition 50 years ago a sulfur drug gave complete relief in a couple days.
Now BIG PHARM has Lyme patients on FQ’s for years. Now that Lyme is going to affect approx a million people due the warm weather and the infection becoming harder to get rid of the symptoms because once considered a chronically Lyme patient getting rid of it is nearly impossible. People are now hailing Cipro as a an amazing drug for Lyme and it doesn’t kill the bacteria it just helps the symptoms after long term doses. I was saddened when I attended a Lyme support meeting and was trrated as an outcast because I won’t do anti biotics. They don’t work they hide the fact that the infection will still exist and one day in the future the Lyme Disease will takes its toll on lives creating illnesses. You can kill off infectious bacteria with natural remedies after all the bacteria is natural and have natural enemies that do kill them off. People swear by Cipro…I found out the hard way in front of a group of about 45 people. I was floxed in 90’s and 2099, 2012 but also contracted Lyme while I’ll when my Son’s dog kept me company….then spiraled in 2012 not diagnosed til 11 months ago..FQ black box warnings do not matter to Lyme victims the pain is horrible the neuro issues are dangerous dye to infectious bacteria entering the brain but anti biotics do not reach the bacteria because the bio film protects the infectious bacteria, co infections and virus and fungal issues…there seemed to be hope for the truth re: FQ’s but with the Lyme eoudenuc looming it’s something I witnessed people passionately fighting FOR!! So shocking when it will just mask the Lyme and allow the damage to the patient to continue..