What is a Black Box Warning?

The Strongest Safety Warning a Medication Can Carry

For years, these were prescribed routinely for sinus infections and urinary tract infections. But then something alarming started happening. Patients would take the pill, and their Achilles tendon would rupture out of nowhere.

We now recognize a whole condition called Fluoroquinolone Associated Disability Syndrome, or FQAD. It can cause permanent nerve damage, psychiatric issues, and chronic muscle pain.

There is even a theory that “Gulf War Syndrome” was actually FQAD in susceptible service members. Many military personnel were given Cipro at the time to prevent anthrax.

Because of this, the FDA Black Box Warning clearly states that these drugs should only be used if there is no safer alternative.

But here is the scary part. I still see them prescribed for routine infections all the time. Safer antibiotics would work just as well.

I had a patient who was given Cipro for a simple urinary tract infection. Weeks later, she developed severe tendon pain that lingered for months. She had no idea she was taking a drug with a Black Box Warning. Nobody told her.

So here is my advice. When you pick up a prescription, read the warnings. Ask your pharmacist about any Black Box Warnings. You have the right to know what you are putting in your body. A few minutes of reading could save you months of suffering.

Authored by Gerard Guillory, MD

Gerard Guillory, MD, is a board-certified internist who practiced for nearly four decades with a focus on functional, root-cause medicine. He is the author of three books on irritable bowel syndrome and the founder of It’s My Health, where he and his team put current health news in context and help members understand the underlying causes of chronic symptoms.