Between 2010 and 2016, the FDA fielded more than 31,000 complaints involving just one member of the fluoroquinolone family, Levaquin. Hundreds of those complaints involved depression and anxiety.
South Carolina's pharmaceutical watchdog Dr. Charles Bennett petitioned the FDA in 2014 to add a black box warning for psychiatric adverse events to Levaquin's label.
Heather McCarthy says her son Shay never experienced mental health issues until a doctor prescribed Levaquin as a preventative following a simple surgery.
Within months, Shay dropped out of Purdue University and wound up on more drugs to treat bi-polar disorder. In 2013, he jumped out of a 2nd floor window and ran his car into a concrete barrier.
Heather added her voice to those pleading with the FDA to do more to warn people about the mental health side effects linked to fluoroquinolones. We asked the FDA what was taking so long and in an email the agency said:
"The FDA is carefully reviewing available scientific information and will determine appropriate actions when this review is complete."
Currently, the labels on members of the fluoroquinolone family including Levaquin and Cipro contain warnings that range from depression to insomnia to suicide. Here's the problem, we found risks buried in the inserts.
Take Cipro for example: you’ll find the warning on page 9 of the 31-page insert. Many patients never see the fine print and some of those affected never recover.
Eleven months after taking her last dose of Levaquin, Cobb continues to suffer from extreme pain in her tendons. Levaquin's black box warning includes the risk of tendon rupture but for Cobb the depression and insomnia hurt just as much.
The FDA estimates only 1 to 10 percent of those who suffer side effects actually report them. For every Shay McCarthy there could be between 10 and 100 others whose stories go untold.
The FDA could take several more years before deciding on the petition to black box what may be the most serious side effects connected to a drug taken by an estimated 22 million people.