Digest of recent discussions on ISSM mail (May 2009 - Aug 2009)

IV

IRWIN GOLDSTEIN

Testosterone Gel Transfer                                                                            

                                                                                                       1 June 2009: 10 messages

1

Recently the FDA has issued a black box warning to the manufacturers of 1% testosterone gel products concerning the dangers of the use of topical testosterone gel in men with hypogonadism resulting in unwanted transfer to spouses, partners and/or children.  We have surprisingly little information on this in the JSM.  Has anyone ever seen a case of this?  Would you be willing to write a case report/letter to the editor on this topic?

Irwin Goldstein (dr.irwingoldstein@GMAIL.COM)

2

I have never seen it personally but always warn patients of the potential risk of transfer. It is reported in the literature and I have attached two relevant papers

Chris G McMahon (cmcmahon@ACSH.COM.AU)

3

I totally agree with Chris. I have never seen this (but was aware of the papers) and yet we do not routinely seek this information from the partner. Strict adherence to the SPC in applying the drug in the morning before dressing should render transfer very unlikely but patients often forget in the morning and apply it later in the day when they remember.

Geoff Hackett (geoff.hackett@VIRGIN.NET)

4

Never seen one. Perhaps the instructions to patients need more emphasis on this issue and you might see it more often in practitioners unfamiliar with the use of T.

                                                              Alvaro Morales (moralesa@POST.QUEENSU.CA)

5

I have not seen this either, but the pediatric cases reported prompted the black box warning.

In the original trials for Androgel, a study was done where the female partner rubbed against the male partner using the gel, in an exaggerated manner. Levels of T were significantly higher in the women but not out of the normal range. The recent case reports the FDA is worried about prompted concern for children. I wonder whether there is less chance of this with Testim as the gel is rubbed into the skin, with less residual on the skin than with Androgel. No studies on this that I have seen.

Andre T Guay (Andre.T.Guay@LAHEY.ORG)

6

I generally advise the patient not to have any skin to skin contact within 6 hours of application: the risk of transfer after this length of time is very small [`NO contact at all’ is advised for pregnant women].  I also sometimes advise that they have a shower 6 hours after gel application before skin to skin contact.
                                                                Duncan Gould (duncangould@HOTMAIL.COM)

7

Dear Irwin: I have a very interesting recent case of gel transfer to the partner more than 8 hours (!) after application in a patient who had graft vs. host disease following a bone marrow transplant. I had started him on one of the gel formulations after documenting his hypogonadal sex & low testosterone levels. I have to review the chart for the exact details of the timing, but I think about a month after starting therapy, the couple noted that the female partner was developing severe acne. The problem was resolved when the patient was instructed to avoid applying the gel to the shoulder on the side where his wife was sleeping at night. I now routinely make this recommendation to all my pts receiving the gel formulations and am planning to submit the case as a letter to the editor or a brief case report in the very near future.

Hossein Sadeghi-Nejad  (hossein@IX.NETCOM.COM)

8

In addition to being highlighted in the printed PI of the pharmaceutical company, the possibility or risk of gel transfer should be included in the pre-prescribing face-to-face discussion with the patient. 
Another reference on the topic may also be of interest: 

Stephen MD, Jehaimi CT, Brosnan PG, Yafi M. Sexual precocity in a 2-year-old boy caused by indirect exposure to testosterone cream. Endocr Pract. 2008:1027-30.
The issue is also relevant and applicable to other topical endocrine and possibly non-endocrine preparations.

Taylor MB, Gutierrez MJ. Absorption, bioavailability, and partner transfer of estradiol from a topical emulsion. Pharmacotherapy. 2008;28:712-8.

 Kew Kim Chew (kewkimchew@HOTMAIL.COM)

9

Dear Irwin: Since virtually no prescriber of T-gels has seen such a case, myself included, why don’t you put on your investigative journalist’s hat and research how this warning came about; then write your own story.

Joel Kaufman (JoelK1123@COMCAST.NET)

10

I have never seen it but always mention it to the patients; about intimate physical contact to the application site within 1 hour. I suggest that they wear a t-shirt if there is going to be contact.
Same idea as women handling the 5ARI meds.

                                                                             Jack Barkin (j.barkin@ROGERS.COM)