FDA Mandates Black Box Warning for Some Antibiotics

[Horse with no Name]

Oh great! Something to look forward to (as I am in the 20th day of a 30 day prescription of Levaquin).



http://www.ajc.com/health/content/shared-auto/healthnews/antb/617305.html
TUESDAY, July 8 (HealthDay News) -- Antibiotics known as fluoroquinolones will need to carry a black box warning alerting physicians to the increased risk of tendonitis and tendon rupture associated with their use, the U.S. Food and Drug Administration said Tuesday.

This risk is greatest among people over 60; in kidney, heart and lung transplant recipients; and among those taking steroids, the agency said.

The FDA is also asking doctors to advise their patients that if they have any sign of tendon pain and swelling or inflammation, they should stop taking the drugs immediately. Patients also should avoid exercising the affected area and contact their doctor immediately.

Tendon rupture can occur during or after taking fluoroquinolones, which include Cipro. Cases of tendon rupture have been reported up to several months after completing fluoroquinolone therapy, according to the FDA

[Warpy]

1. Don't trouble trouble unless trouble troubles you.

The statistics are still with you, that you'll finish the drug, be completely over the infection, and have no problems down the road.

A black box warning means docs and pharmies will need to warn patients that there is a significant side effect for a small number of people, that they need to be aware of that side effect, and what actions they need to take should they develop it.

I took Cipro after being on corticosteriods for 10 years without a problem. It killed a resistant bug and didn't do anything else.

As always, powerful drugs have to be assessed by a risk/benefit equation. The benefit generally outweighs the risk and that's why the drugs stay on the market with warnings.