Testosterone Replacement Therapy and Blood Donations

Testosterone Replacement Therapy (TRT) is a medically supervised hormone replacement therapy used to alleviate symptoms associated with low testosterone. Low testosterone has been linked to an increased risk of cardiovascular disease and mortality as well as associated with symptoms such as depression, decreased sex drive, fatigue, irritability, and decreased muscle mass. FDA approved testosterone therapies include topical gel, transdermal patch, buccal system, and injection. Androgel and Testim are examples of prescription topical testosterone and are FDA approved for TRT.

While on TRT patients need to be monitored very closely due to the increased the risk of thrombosis and stroke. Increased testosterone has also been shown to cause polycythemia, an increase in red blood cells, resulting in an increase in blood viscosity. If this occurs patients on the therapy need to lower their dosage or discontinue treatment. However, another option is to donate blood on a regular basis. This donation would be categorized as a therapeutic phlebotomy and is a special donation that requires physician approval.

A variance is listed under Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 to “Allow individuals on prescription testosterone to donate blood and blood components more frequently than every eight weeks without examination or certification of health by physician at time of donation, provided the donor is referred with a prescription by a physician containing instructions regarding frequency of phlebotomy and hematocrit/hemoglobin limits and to be exempt from placing special labeling about the donor’s disorder on the blood components. This approval is granted under the condition that only the Red Blood Cells collected from these individuals may be distributed; the plasma and platelet components from these individuals should not be distributed for transfusion.”

In these therapeutic phlebotomies in which a variance is obtained by the blood center, the red blood cells are used and the plasma or platelets are discarded.   Have blood centers seen an increase in therapeutic donors due to TRT therapy? Obtaining a variance for TRT donors may be an opportunity for a blood center looking to increase their available donors. Is this something your blood center has considered or implemented? Should TRT donors be handled any differently in comparison to other therapeutic phlebotomies?

Blog author: Jacqueline Ensley, MLS(ASCP)SBB – Kentucky Blood Center

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15 Responses

  1. Testosterone Donors – A Real Shot in the Arm for Our Blood Supply

    Our experience with testosterone replacement therapy (TRT) started approximately 3 years ago when we began seeing an increased number of male donors arriving at fixed and mobile sites proclaiming that their doctor had advised them to donate blood. This statement naturally raised a “red flag”. Upon further questioning we discovered these donors were on TRT. Since testosterone was not listed as a medication of concern – we initially handled these donors as allogeneic donors without physician orders. During a FDA Liaison meeting in May 2013 a FDA representative when asked how blood centers should manage these donors he replied – therapeutic phlebotomy discards. We quickly revised our SOPs to comply and just as expeditiously applied to the FDA for a variance to allow us to manage these donors as allogeneic if they met the criteria or no-charge therapeutic discards if they did not meet criteria.

    We used our hemochromatosis FDA variance, we had obtained in April 2001, as a model for the TRT variance submission. We were pleasantly surprised when the FDA approved our variance request within 6 months of submission. The approved variance did have some caveats – no plasma/platelets and 16 weeks between double RBC donations. We lost a few loyal male apheresis platelets donors as a result. When informed of their ineligible status for apheresis platelet donation, donors naturally asked what they had to do become eligible again. When told that that they would have to stop TRT most shook their head and stayed on therapy.

    With variance in hand we quickly revised our SOP, pre-donation donor information and computer systems and went “live” with TRT donors in June 2014. Critical control points were identified frequent audits were performed to assure compliance. To support seamless access to TRT donors we developed a TRT Physician Order Form to facilitate orders. With the donor’s approval, our donor staff does the “leg work” to get the MD orders. Orders are good for one year. Documentation of MD orders are inputted into our computer system to allow for TRT collections at both fixed and mobile operations.
    We are now on pace to collect 1,400 units of transfusable RBCs from TRT donors this year. I expect that number to increase as the word gets out to our prescribing physicians and TRT patients.

    Not to be complacent, on July-21-15 we applied to the FDA for a modification to our TRT variance which would allow us to collect, manufacture and transfuse plasma and platelets from these donors. Stay tuned – we’ll let you know what happens.

  2. Mike Smith says:

    My blood bank (one blood in Melbourne FL) turned me away when I talked about my TRT. I do not understand the reason for this. I donate blood on a normal schedule and do not need to give blood more frequently. What is the risk of using blood from someone on TRT?

  3. J. Ensley says:

    @Mike Smith- sorry for the delay in response.

    There has been some confusion surrounding this topic and it is a fairly recent issue. Blood Centers must follow FDA guidelines and currently men presenting to have blood drawn due to polycythemia from TRT cannot donate as a regular donor but they may be able to as a therapeutic donor if they meet certain requirements at certain blood centers. It sounds like @David Gremillion’s blood center is doing a great job managing and helping those on TRT therapy.

    The FDA has set in place these guidelines for men on TRT because plasma testosterone levels in men with testosterone-induced polycythemia have not been fully studied – it is not clear whether they have normal testosterone levels or their levels are high. High testosterone levels could potentially affect some patient populations that receive transfusions, such as neonates. Until additional data is obtained, the FDA will keep these restrictions in place. Regulations are continually changing as new data is presented and the FDA is interested in keeping blood donors as well as patients safe.

    Also, blood centers may make individual decisions regarding donors on TRT. They must at the minimum follow the FDA’s general guidelines but may be more restrictive at the Medical Director’s decision (i.e. some blood centers may choose to defer all donors on TRT).

  4. Randi McKissick says:

    What is the issue with donating while on TRT, @ J. Ensley, I see that you say it’s not clear whether or not they have normal testosterone, but if they had normal testosterone, why would they be on TRT? I definitely agree with taking the most conservative route because patient safety should always come first, but perhaps this topic needs some more attention.

  5. Kelly says:

    My sister continues to have VERY high testosterone for a woman – naturally – which helps to protect her from the pain of our inherited gene of Ehlers-Danlos syndrome. I used to have high T (TWICE what I have now, though in the 60s or 70s, and hers had been more that DOUBLE that at points!), and with that, I was nearly asymptomatic…but Fluoroquinole antibiotics activated the EDs gene, which also comes along with many co-morbid conditions. I’ve seen T help patients with the pain of fibromyalgia and other chronic pain disorders (in studies), and have asked both fellow PCOSers and FTM trans men with EDS if they have seen their pain and other symptoms improve with increased T – the answer was a resounding yes!!
    Unfortunately, I’ve gotten worse as I’ve had to start taking medications for my chronic pain…I’ve been getting sicker and weaker (estrogen is worse for my vascular system, and I’ve suddenly gotten MUCH MORE involved problems…and progesterone increases my joint laxity, which makes me more likely to dislocate or sublux joints (yea…EDS is NOT a fun disease!).
    Does anyone know if my sister, with her EXTREMELY HIGH T levels, would be able to donate blood to me? Would her INCREASED T be able to help to increase mine, via a directed blood donation? And if so, would it be something that I would even get a doctor to DO? I’ve done a great bit of study on this…and believe that it will help me. But no idea where to even start.
    Would even be happy to know which supplements, foods, vegetables, etc could help me to increase T, if I’m not able to get a small amount of gel to help me.

  6. Kelly says:

    To make my previous comment clearer, the medication decreasing my T, has made me more susceptible to E and P damage, and the medications’ dropping of my T levels also causes the meds to not work as well…double whammy

  7. testosterone says:

    Will. Any opinion on the new T booster been pushed by Joe Rogan for He’s a reputable guy right???!

  8. Darin Mason says:

    Testosterone Replacement Therapy can prevent or reduce the likelihood of developing Diabetes, Cardiovascular Disease, Obesity, Osteoporosis, as well as Depression and Anxiety. Other studies have shown that long-term use of testosterone (7-10 years) was effective in maintaining bone density and muscle mass. What I consider the “Holy Grail’ of testosterone research came out in 2015, involving over 83,00 European veterans with low testosterone. Results showed that patients with low testosterone who underwent Testosterone Replacement Therapy (TRT) and whose testosterone levels were normalized were 56% less likely to die from any cause compared to those patients with low testosterone who were not treated. They were also 36% less likely to suffer from a stroke and 24% less likely to have a heart attack. The bottom line is; if you suffer from low testosterone and you want to live a long life, you are more likely to do that if you are on testosterone.

  9. says:

    thanks for the info

  10. Gabe says:

    I recently started a TRT program. I went to a Red Cross donation center to donate blood a week or so ago. because of my blood type, they really pushed the Power Red on me. I did the Power Red donation, it made sense to me…..

    Is this sufficient for donating blood on TRT? Has anyone else done this or doing this?

    Thank you in advance!

  11. jamie says:

    hi your site is really awesome

  12. DOCJP says:

    @Gabe, now you will need to do a whole blood transfusion, now you will need to wait approximately 120 days before donating again. You should see your doc about this.

  13. Ron erue says:

    I live in Washington state, and i have, lets say a less than competent endo doc. That 2 years ago took away my TRT due high rbc levels. When asked how to lower them he had no idea. Well after researching it i found that donation was key. So now i donate every 56 days or so with the Red Cross. I have been told by the Red Cross and blood works nw that if i were to go to therapeutic blood draws this would cause a charge and the blood would be discarded. I have AB- so that would be bad on multiple levels. From your article i get the impression that there may be a way to donate more frequently and still have it be no charge (i dont have insurance) and still use the donation for others. Can you help with info?

  14. total tclinic says:

    good site thanks for sharing

  15. total tclinic says:

    hi there thanks for the information

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