It is imperative that when we look at the FDA Adverse Event Reporting System (FAERS) data, we always remind ourselves that we are looking at a very small piece of the pie. The numbers only give us a glimpse of the something much, much larger.
As a reminder, the data we see differs in orders of magnitude. Research tells us that only 1% to 10% of actual adverse events are reported to the FDA.
Also, we cannot assume that reporting is constant across all types of adverse events. For instance, more people are more likely to report tendon ruptures than to report mental health issues. This is due to the general stigma of mental health issues in the world today. Because of this, the reported number of adverse events involving mental health issues is probably closer to the 1% figure.
As you can see from the table below, according the FAERS data on Levaquin, there have been between 990 to 9,900 adverse events pertaining to a “Danger to Others/Anger.” This is obviously very disturbing that an antibiotic, which is often given out for routine infections, may result in a level of violence or anger toward others. These “Danger to Others/Anger” Adverse Events are not listed on the Levaquin label anywhere.
Furthermore as evidenced by the table below, there have been 1,930 to 19,300 adverse events pertaining to “Suicide.” It is terribly disturbing that 280 to 2,800 have “completed suicide.” And again, it is obviously very disturbing that an antibiotic for routine infections may result in this level of Suicide-related Adverse Events. Although suicide is on the Levaquin label, (“rarely, suicidal thoughts or acts”), because of the obvious seriousness of this adverse event, it needs to be in a Black Box warning as Dr. Bennett requested in his Citizen Petition submitted to Dr. Hamburg, then FDA Commissioner, September 2014.
Detractors like to use the word ‘rare’ when it comes to adverse events associated with the FQ’s. Using dismissive phraseology such as this is both a misrepresentation and an insult. It is designed to shield those who do not want to look at the horror that these drugs can inflict upon innocent lives. It is also an insult to everyone whose lives have been touched by psychiatric events associated with these drugs, when in many cases a safer alternative was available.
If even one person was placed in personal danger, or if even one family faced the horror of suicide as a result of the fluoroquinolones, that would be too many. But as we see, these troubling numbers speak for themselves.
Let’s continue to work together as a community for the safety of our families, friends, and neighbors. Let’s continue to work together to bring justice to those who have been harmed by these drugs.