FDA Proposes New Labels To Be Placed on Drugs With Albumin

Posted on June 12, 2012

The Food and Drug Administration is planning on adding new warning labels to certain types of drugs.

The comment period has opened up on the FDA’s proposed plans to mandate various labeling requirements on drugs that contain what’s known as albumin.  Any drugs which have albumin, which is derived from plasma, will now have to have labels that reflect the FDA’s worries about the transmission of various viral diseases.

In 2010, the FDA added various labeling requirements for blood transfusions.  These labels targeted the potential risk of spreading Creutzfeldt-Jakob Disease (CJD).  This latest decision extends those warnings even further to the aforementioned albumin products.

If the FDA decision becomes final, then drugs that have albumin derived from plasma will carry a similar warning about Creutzfeldt-Jakob Disease, as well as a warning regarding the transmission of other viral diseases.  Any risk appears to be incredibly remote, but the FDA looks to be erring on the side of caution.  In fact, the new labels will specifically talk about how the risk is only theoretical at this point.

Products that don’t contain albumin but are still derived from plasma get a slightly stronger warning.  Since such items are created using human blood, the new labels will reflect the risk of the transmission of viruses, infections, and CJD.

Concerned individuals have until September 10 to provide comments to the FDA.

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