Is anyone using an intravenous Rh immune globulin preparation for the treatment of ITP that has not been approved by the FDA for that indication?

A transfusion medicine physician in New York is of the opinion that many members of the medical profession approve of (and even encourage) the 'off-label' use of certain pharmaceuticals for various indications that have not been approved by the FDA. In particular, he wonders if anyone is using an intravenous Rh immune globulin preparation that has not been approved by the FDA for the treatment of ITP (and therefore being used in an 'off-label' fashion).

Editor's note: The articles:

• Dr. M D Nair, Off-Label Use Of Drugs: Safety Concerns (Pharmabiz.com, Oct. 13, 2004)
• Melissa Tennen, Understanding 'Off-Label' Drugs (HealthAtoZ.com, Feb. 17, 2005)
• Jesse C. Vivian, B.S. Pharm., J.D., Off-Label Use of Prescription Drugs (USPharmacist.com, May 15, 2003)
• FAQ on off-label prescribing (obesity-news.com: Obesity Meds and Research News, last accessed Jan. 8, 2006)

provide some background to this discussion.

The following comments have been received.

ADDENDA Jan. 10, 2006

1. A transfusion medicine physician who practices in a state along the East Coast of the US reports that he has heard 'second hand' that "a number of hospitals" use an intravenous anti-D immune globulin preparation that is not approved by the FDA as a treatment for patients with ITP.

ADDENDA Jan. 11, 2006

2. A colleague at the US FDA reported that since the e-Network Forum is discussing off-label use, she thought that colleagues would like to know there is FDA Guidance HERE.

ADDENDA Jan. 13, 2006

3. Prof. Dr. A. Salama of the Charité Campus Virchow Klinikum Institut für Transfusionsmedizin in Berlin (attribution used with permission) reports that at his institution they currently use all available formulations of anti-D immune globulin (including those preparations that can be given via the intramuscular or intravenous routes) for the treatment of ITP, but they limit the administration of the drug to the subcutaneous route. He cautions against administering anti-D immune globulin intravenously, especially in bolus form, given known problems with that route of administration. He is aware of IV administration of anti-D immune globulin causing death in some cases. He and many of his colleagues have been using anti-D immune globulin in the treatment of ITP since 1983, and over most of that time period they have administered anti-D immune globulin intravenously only after dilution of the drug in at least 100mL saline solution. More recently (over the last two years) they have been administering the drug subcutaneously. So far none of their patients treated with subcutaneous anti-D immune globulin have developed acute adverse reactions, and the therapeutic effect that they have observed has essentially been equivalent with intravenously administered anti-D immune globulin (Eur. J. Haematol. 2004: 73, 71-72).
   
   Dr. Salama laments that his appeals to colleagues to administer anti-D immune globulin by the subcutaneous route (rather than the intravenous route) have remained largely unheard. Perhaps recent well publicized adverse reactions associated with the intravenous administration of anti-D immune globulin might stimulate new evaluations of the efficacy and safety of using alternative drug delivery strategies.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator