New Label Request From FDA Targets Topical Antiseptic Safety

Posted on November 15, 2013

When you go in for surgery or even something simple like a flu shot, the first step that will happen before you actually receive treatment is the nurse or doctor will apply a topical antiseptic solution.  With that complete, they’ll then get on with the process of providing you with care.  However, a recent trend has the Food and Drug Administration concerned that these antiseptics may pose a risk to consumers under certain circumstances.

The agency is asking the makers of these topical antiseptics to begin boxing them into single use packages that have labels clearly delineating the proper methods for usage.  The FDA is then asking medical professionals to heed these directions when seeing to the care of a patient.  That means that each should only be used one at a time and doctors should not compromise the integrity of the antiseptic by diluting it in some way prior to administration.

The need for such a move became apparent as the CDC has begun to receive reports of antiseptics leading patients to experience an infection.  This, along with other instances of outbreaks outlined through medical literature, prompted the FDA to launch an investigation into the issue.

With four deaths and a number of other injurious circumstances, the FDA determined that these antiseptics could potentially be contaminated by those handling the items inappropriately.  Thus, the aforementioned action was deemed necessary.

How Can We Help You?

If you have a legal matter you would like to discuss with an attorney from our firm, please call us at (310) 477-1700 or complete and submit the e-mail form below, and we will get back to you.

  • This field is for validation purposes and should be left unchanged.
  • This field is for validation purposes and should be left unchanged.

*Required Fields