FDA Calls for New Warnings on GnRH Agonist Labels

[Guest guest]

Hi Chuck,

I agree with you that physicians should absolutely tell patients about the potential dangers of LHRH/GnRH, and I'm glad that you are bringing the new FDA warning to the attention of the readers.

I'd like to raise an even more fundamental question.  Are patients being informed that the FDA ruling is: " GnRH agonists are indicated for the palliative treatment of symptoms of advanced prostate cancer. "   When an oncologist or urologist prescribes LHRH/GnRH to the patient who does not have symptoms of advanced prostate

cancer, does the patient realize that this is actually off label use not recommended by the FDA as a standard of care treatment?

So giving primary hormonal blockade indiscriminately or giving it to patients after failure of primary treatment is actually not the FDA approved usage.  That does not mean that I think that no one should get hormonal blockade for situations not approved by the FDA; in some cases it is called for.  All I am saying that we should avoid overtreating patients that do not need it and exposing them to potential side effects. In the case of LHRH/GnRH, these potential side effects, particularly the cardiac side effects, can be quite significant. To combine the question that you raised with the question I raised, I will summarize our discussion points this way.First,

all doctors should tell their patients whether hormonal blockade is indicated in their case in line with FDA recommendations.  Patients should understand it may be off label use and still experimental by definition.

Second, all doctors should tell their patients about all the potential side effects and weigh risk versus benefit with the patient.Our

goal should be to become more discriminating with patient selection and

not over treat with combined hormonal blockade.  When we say that prostate cancer patients are overtreated, we should not look only at surgery and radiation, but we should look more intelligently at how we are treating with LHRH/GnRH as well.

 

Chuck, thank you again for raising the flag and opening the discussion, and I wish you many more years of good health.  We need good men like you leading the prostate cancer cancer community. 

 

Coach Barken (Israel Barken, M.D.)   -- Coaching with Dr Barken --- http://www.pcref.org/per.coaching.phpTo listen to previous recording of Ask Dr Barken Show  go to-- http://www.pcref.org/call_past.php

To open your own Medical Smart Chart go to -- www.pcref.org/MedSmartChartMaterial posted here is for general education purposes only and does not take the place of medical advice from your treating physician.  No patient-doctor relationship is created or implied.

Israel Barken, M.D. Medical Director Prostate Cancer Research and Eduction Foundation (PC-REF) 501©3 non profit organization 6823 Deer Hollow PlSan Diego, CA 92120www.pcref.org

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