Charles Bennett M.D. Ph.D. M.P.P., Chair of the Center for Economic Excellence in Medication Safety and Efficacy, University of South Carolina presented at the PharmedOut’s 5th Annual Conference on June 12, 2015 at Georgetown University about Fluoroquinolones.
PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
Dr. Bennett presenting at PharmedOut 2015
The Following is a synopsis of Dr. Bennett’s presentation:
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?
Dr. Bennett asked the question: “Should black box warnings for Fluoroquinolones be revised: Is the bar set too high?” The following is a summary of Dr. Bennett’s conclusions.
1) Conclusion: The FDA’s legal bar related to Black Box Warnings is not too high.
• Code of Federal Regulations, Title 21, states that adverse events that “may lead to death or serious injury, may be required” to be in a Black Box. Fluoroquinolone antibiotics have adverse events that “may lead to death or serious injury,” including possible Mitochondrial Toxicity, implicated in neurodegenerative diseases, such as ALS, Alzheimer’s, and Parkinson’s.
• Fluoroquinolone antibiotics require a Black Box Warning regarding possible Mitochondrial Toxicity.
2) Conclusion: The Industry Guidance bar related to Black Box Warnings is not too high.
• According to non-binding “Industry Guidance,” Black Boxes may be needed if “there is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”
• Fluoroquinolone antibiotics have adverse reactions “so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug,” including possible Mitochondrial Toxicity, implicated in neurodegenerative diseases, such as ALS, Alzheimer’s, and Parkinson’s.
• Fluoroquinolone antibiotics require a Black Box Warning regarding possible Mitochondrial Toxicity.
3) Conclusion: The legal and Industry Guidance bars are not too high. The problem is that the FDA has failed to do its job regarding Fluoroquinolone antibiotic safety. Specifically, the FDA has failed to act on the 2014 Citizen Petition asking the FDA to add Fluoroquinolone warnings of possible Mitochondrial Toxicity, implicated in neurodegenerative diseases, such as ALS, Alzheimer’s, and Parkinson’s.
Dr. Bennett’s presentation was well received by all who attended.
Following Dr. Bennett’s presentation, John Fratti and Linda Martin, as representatives of the FQ community, were available at the conference to answer questions from the perspective of a ‘floxed’ individual.
Thank You to Linda Martin and John Fratti for attending the conference and representing the FQ community.
Also, a very big Thank You to Dr. Bennett for his ongoing research in addition to his willingness to travel and present findings on Fluoroquinolones to the current academic medical establishment in his pursuit of medication safety. His efforts will ultimately allow patients and medical professional to make more informed and safer healthcare decisions.
Stay vigilant, stay informed, and stay tuned to My Quin Story for true and timely updates on our interactions with the FDA, the Citizen Petitions, and FQ community related research.
Dr. Bennett presenting at PharmedOut 2015
Dr. Bennett
#FDAFail
Thank-you for your concern & time spent making them aware of the dangers of Fluorquinolones.
I haven’t been able to work in 14 yrs. my SS & savings has suffered immensely. Pursuit of happiness? Not with this poison in our health care system. What happened to Do No Harm. Medicine was better 30 years ago than today.
Doctor Bennett is a true hero for telling the truth about how harmful fluoroquinolones can be and for making waves about it. The truth is that BIG PHARMA is more ruthless and dirty than any novel or Hollywood movie will ever be able to reveal. Their goal is to sell more drugs, period. They will do whatever it takes to make that happen, including bribery, fraud, money laundering, intimidation and bullying, and even murder. The truth is that they are committing murder all day every day by continuing to mass market dangerous drugs, especially fluoroquinolones. Most of the time they are pushing a drug despite the fact that it is known to cause some sort of serious damage to the patient, for example heart attacks or liver damage. Fluoroquinolones are being mass marketed because of the damage they do to the patient, damage which is usually from head to toe. The average victim of fluoroquinolone toxicity suffers a syndrome, with many different horrific “symptoms” which are usually very painful, often debilitating and at times fatal. Considering the FDA admits that their woefully inadequate reporting system for adverse events, called Med Watch, catches only 1% to at most 10% of all incidents, and that most people who have adverse reactions to fluoroquinolones never make the connection to the drug because the damage shows up weeks, months, even years after discontinuation, the sad and sorry truth is that the 5,000 or so deaths the FDA attributes to fluoroquinolones actually represents at least 50,000 actual deaths and more likely a number in the range of 500,000. Yes, that’s right, these drugs have killed half a million Americans, and millions upon millions world wide. Worse yet, they have left tens, or even hundreds of millions of people damaged, some severely, and other who just feel run down or who get pain in their joints or headaches or any of a thousand or more other little problems. These drugs are fantastic at getting to infections in remote places like in bone marrow, which is why they do so much damage throughout the body; unfortunately most people who get these drugs do not need the atom bombs of the antibiotic world. In fact, according to Dr. Bennett, in a recent television interview, most did not even need an antibiotic at all. BIG PHARMA knows this and yet they go out of their way to convince the medical community these drugs are the gold standard in safety which is why the victims run into a solid wall of denial whenever we suggest that the drugs are causing all our problems. The more problems we have the bigger their disconnect; they are so convinced it has to be something else that they will spend inordinate amounts of time and money on test after test while we suffer. They often insist we take more drugs to treat whatever misdiagnosis it is they have come up with which ends up worsening our problems instead of helping us. Even then they will still be likely to deny the further damage they are doing. The truth is that the medical profession is doing a really terrible job. They are absurdly and dangerously overconfident in the quality of their services and wares, and that is why so few of them will report the damage these drugs have done. That is why I consider the half million deaths figure to be low. This is murder, plain and simple, and we should not be satisfied until the executives of Bayer and J$J, past and present, are all serving life sentences for crimes against humanity and every penny they have is seized as proceeds of crime in order to compensate the victims. In fact, these corporations do not have a God given right to exist. These companies should be seized and dismantled. BIG PHARMA must be reduced to little pharma or better yet, production and distribution of drugs should be socialized to remove the profit motive from the loop. Instead of producing drugs to make money, we can produce drugs to make people healthy. Anyway, thanks again Dr. Bennett for the great job you are doing, and you too David for your great blog and all the other work you do on our behalf. I look forward to meeting both of you some day. This story is just getting started. We have some huge victories coming our way…