Putting a Face on Black Box Warnings

Reading about drugs can almost be like reading a dictionary. After a while, the textbooks are just words. When we make these situations personal and put stories behind them, they come to life and have meaning.

I’d like to do that with ciprofloxacin and the black box warning that the FDA has attached to it and all fluoroquinolones. Keep in mind that there are always 2 sides to every story, and that means every drug has the potential to do both good and bad.

Just recently I read and was deeply saddened by an online blog about a woman who took cipro for a urinary tract infection and experienced a horrific life changing side effect from the antibiotic. It caused several of her tendons to rupture. As a result, she spent a lot of time in and out of hospitals.

The FDA and Society of Infectious Diseases has confirmed that cipro can have permanent, debilitating side effects.

The FDA canNOT remove it from the market under these circumstances because it’s the only ORAL antibiotic that treats an aggressive bacteria called pseudomonas. Pseudomonas is a superbug that can cause fatal infections. When I think of pseudomonas I think of hospital-acquired pneumonia, urosepsis, and diabetic foot infections. Pseudomonas is so serious, that the Society of Infectious Diseases has separate duration and treatement guidelines when treating certain types of pseudomonas infections. Pseudomonas will keep returning unless aggressive measures are used.

Practioners in some areas of the Unites States use 2 antibiotics to treat pseudomonas because it is so aggressive and can mutate. We call this double coverage. Not all bacteria need double coverage, but a life-threatening pseudomonas infection in the hospital setting sometimes does.

When I say that cipro and all fluoroquinolones are the only oral antibiotics to date to treat pseudomonas in a pill form, that is big deal. Of course, pseudomonas can mutate and become resistant to cipro. In that case the patient is relegated to IV antibiotics, which are very expensive and time consuming.

Here is my best advice to keep the public safe. Do exactly what the FDA says. They have put a black box warning on cipro and all the floroqu

inonlens stating don’t use cipro unless there are no other options. Acute sinusitis, acute exacerbations of chronic bronchitis, simple urinary tract infections are easy cured with safer antibiotic.

Often times patients have multiple drug allergies, which force providers to use cipro even if pseudomonas is not a concern. I wish every time a provider wrote a prescription for a quinolone they were forced to also write on the prescription the type of infection being treated, if there were confirmed microbial cultures growing pseudomonas, and if the patient has drug allergies. That way, the provider will be forced to put more thought into prescribing cipro. Also, the pharmacist can double check if the situation is complicated and serious, or simple and easily cured with a safer antibiotic.

The FDA also says if you experience pain in your limbs, stop exercising immediately and rest your body. Call your doctor and tell him/her what is going on.