The I-Team has reported on the dangerous reactions linked to antibiotics like Levaquin, Cipro and their generic counterparts since 2015, and now the FDA is ordering a black box warning for the strongest of these drugs.
For Jill Cobb a new black box warning label comes too late. She's dealt with anxiety, panic attacks and insomnia for the past year and a half.
It all started after a doctor prescribed Levaquin for an infection.
More than 20,000 people who've taken Cipro, Levaquin and other fluoroquinolones reported psychiatric side effects to the Food and Drug Administration.
Fluoroquinolones are antibiotics commonly used to treat illnesses.
Reported side effects ranged from insomnia and anxiety to attempted suicide.
Dr. Charles Bennett petitioned the FDA 4 years ago to enhance the physical and mental health side effect warnings.
Two years later regulators approved a portion of the petition, mandating a black box warning for fluoroquinolones over the link to tendon, muscle and nerve pain but the government failed to act on the reports of adverse psychiatric reactions until now.
The government’s own data indicates 120 fluoroquinolone related suicides.
When we asked about this back in December the FDA said they were still reviewing data.
Now the drugs’ black box warning, the strictest warning for drugs, will include psychiatric effects.
Meaning the language will no longer be buried deep in the label.
Drug makers have 30 days to respond.
Anyone who suffers an adverse reaction to any drug is encouraged to report it to the FDA.