What Your Doctor Doesn’t Tell You About…Lupron Depot

What your doctor hasn’t told you about LupronÃ?® may be influencing your decision to take the drug, without having all the information you need to make an informed and empowered choice about your health treatment options. For the purposes of this article, the focus will be on the use of Lupron DepotÃ?® specifically as a treatment for the disease, Endometriosis.

LupronÃ?®, manufactured by Takeda Abbott Pharmaceuticals [TAP] is a member of the class of medications known as gonadotropin-releasing hormone [GnRH] agonists. It works by suppressing the body’s production of certain hormones, thereby allowing it is be used as a treatment in specific hormone-dependant disorders in men, women, and children. LupronÃ?® is *only* FDA-approved to treat Endometriosis, Prostate Cancer, Central Precocious Puberty, and Fibroids. All other uses of the LupronÃ?® – including long term therapies – are considered “off-label.”

GnRH agonists work to manage Endometriosis specifically by stimulating the pituitary GnRH receptors, causing the ovaries to produce more estradiol (the most potent form of estrogen). In the second phase of the drug’s therapeutic action, after approximately 7 to 21 days of constant stimulation, it shuts down the “messenger” hormones sent from the pituitary gland to the ovaries. This results in decreased pituitary secretion of hormones, including luteinizing hormone (LH) and follicle stimulating hormone (FSH). The patient ceases to ovulate or menstruate; a condition similar to that of menopause. What your doctor may not have told you is that LupronÃ?® induces what is referred to as Clinical Flare. This exacerbation of your symptoms and side effects will occur, on average, during the first 2 injections. Simply put: you will feel worse before you get better. Addback therapy, often [mistakenly] touted as the cure for all side effects of LupronÃ?®, in reality does little to mitigate the effects of Clinical Flare and side effects for many users.

LupronÃ?® is not a cure for Endometriosis, nor does it have any impact on adhesions and scar tissue so prevalent in the disease. It is merely a temporarily suppressive hormonal medication that relieves symptoms in some users, for some time. What your doctor may not have told you is that Endometriosis recurrence is absolute, the question is only of when. Recurrence rates of disease within 5 years after treatment with a GnRH drug are more than half; in women with severe disease, the rate was much higher – 74.4%.[1]

Off label usage of any drug is, for all intents and purposes, a “try at your own risk” scenario that is unsupported in the scientific and prescribing literature of both the manufacturer and governing agencies. This does not mean such therapies cannot be done; it simply means the therapy involves using the drug in for a length of time or in a manner for which it was not intended or further studied. In their article earlier this year, Forbes Magazine estimated that approximately one in every five prescriptions is used in an off-label manner, but confirmed the expert consensus that “unfortunately, the practice is potentially risky, since three-quarters of these off-label uses lack solid scientific support.”[2] Off-label uses of LupronÃ?® include the use of the drug in post-hysterectomy patients, in adolescents with Endometriosis, in IVF protocols, and in extended dosing regimens.

Your doctor may not have told you that there is no data as to the efficacy – or long term effects – of LupronÃ?® in patients who have previously undergone removal of the uterus, or that the *only* FDA-approved pediatric use is in the treatment of central precocious puberty. You may also not know that there is no data as to the efficacy – or long term effects – of LupronÃ?® in younger patients for Endometriosis. Your doctor may not have told you that the use of GnRH agonists is not new to infertility, and many providers choose to use LupronÃ?® a couple of weeks before starting other fertility meds in order to induce Clinical Flare and stimulate the pituitary gland, thereby causing an increase in the luteinizing and follicle stimulating hormones. As stated by TAP, there is no evidence that pregnancy rates are either enhanced or adversely affected by LupronÃ?® [http://pitap.abbott.com/lupron3_75mg.pdf?noCache=]. Patients also need to understand that though they do not – or should not – experience menses during LupronÃ?® therapy, there still exists a small chance that they can become pregnant. As a Category X drug, LupronÃ?® is 100% contraindicated in pregnancy and may cause fetal harm. Women should take barrier methods of precaution to prevent pregnancy during LupronÃ?® usage. Finally, and perhaps most importantly, your doctor may not have told you that LupronÃ?® is FDA approved for the treatment of Endometriosis – and the prescribing information is based on – 2 total courses in a lifetime. That means, if a patient is doing the 3 month injection regimen, she can go on it again for another 3 months; if she is doing the standard 6 month therapy, she can be retreated for another 6 months, and then only under the FDA approval guidelines that the patient *MUST* be given addback therapy in the form of 5 mg. of norethindrone acetate (AygestinÃ?®). That is the *maximum* recommended and FDA *approved* dosing schedule for an Endometriosis patient’s lifetime. Retreatment beyond the approved dosing guidelines is not recommended, as borne out in the manufacturer’s prescribing literature itself, and there is no long-term clinical research on the effects of LupronÃ?® in extended dosing regimens.

Your doctor may also not have told you that LupronÃ?® is not a diagnostic tool for Endometriosis, though many physicians don’t take the time to look past the one small study put out by *TAP’s own paid advisors,* which concluded that LupronÃ?® was a “safe, cost-effective” way of diagnosing and treating Endometriosis in lieu of surgery. This conclusion comes as no surprise, however, as is it not a secret that industry-sponsored research tends to draw pro-industry conclusions.[3] For more information on LupronÃ?® usage prior to a confirmed diagnosis, visit http://www.endocenter.org/pdf/PreDiagnosisGnRH.pdf. Pursuant to this consensus statement that GnRH agonists should be used as a first line diagnostic and therapeutic choice in Endometriosis, there also exists a growing body of practitioners who are opting to forgo surgery altogether. “Surgical complications” and purported equality of diagnostic reliability when comparing GnRH usage versus surgery are cited as the basis for such recommendations.[4] Again, it is not surprising that many of the stronger supporters of such usage are affiliated with the pharmaceutical manufacturers [verifiable via the Takeda Abbott Pharmaceuticals Advisors website, http://www.endofacts.com/support/advisors.htm]. The fact remains, GnRH therapy was not intended, nor should it used, as a diagnostic method or first line therapy. There is a significant lack of comparative analysis to confirm that GnRH therapy is indeed as effective as a diagnostic tool, or as efficacious in long term symptom relief with less or the same degree of negative side effects, as surgery. Therefore, assertions to utilize GnRH agonists as first line therapies are unsubstantiated. Patients who undergo surgery with an expert practitioner – one who accurately understands how to diagnose and concomitantly excise the disease are not only offered a valid diagnosis confirmed by pathology, but also longer lasting therapeutic benefits with less negative side effects.[5]

The most common side effects mentioned by prescribing physician are bone density loss and hot flashes associated with the menopausal state the drug induces. Your doctor may not have told you that there are, however, many other potential side effects [not all of which every patient will experience]. The concept that LupronÃ?® is virtually without side effects – and that any such side effects are basically reversible – is a falsehood. There are countless patients in the Endometriosis community who have been off LupronÃ?® for years and are continuing to experience negative effects from the drug. Extensive side effects have been documented by the manufacturer itself, up to and including – but not limited to:

Asthenia, General pain, Headache, Hot flashes/sweats, Nausea/vomiting, GI disturbances, Edema, Weight gain/loss, Acne, Hirsutism, Joint disorder, Myalgia, Decreased libido, Depression/emotional lability, Dizziness, Nervousness, Neuromuscular disorders, Paresthesias, Skin reactions at injection site, Breast changes/tenderness/pain, Vaginitis, Flu-like symptoms, Heart palpitations, Syncope, Tachycardia, Appetite changes, Dry mouth, Thirst, Ecchymosis, Lymphadenopathy, Anxiety, Insomnia/Sleep disorders, Delusions, Memory disorder, Personality disorders, Rhinitis, Alopecia, Hair disorder, Nail disorder, Conjunctivitis, Ophthalmologic disorders, Taste perversion, and Dysuria. Your doctor may not have told you that LupronÃ?® was also “black boxed” by the FDA in 2005 to include the following in the prescribing literature: “Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour.” [http://www.fda.gov/medwatch/SAFETY/2005/sep05.htm#LupronInj]

This is only a partial listing of side effects, the source of which is TAP itself – not those who “dislike” the drug. It is unfortunate that the many patients suffering long-term negative effects of this drug are disbelieved by society and the medical industry. This may be due largely to the fact that LupronÃ?® is among the most widely promoted drugs. The PR and marketing giant known as Takeda Abbott Pharmaceuticals spends billions of dollars advertising and promoting this drug every year, as well as providing enticing incentives to physician to prescribe it to their patients. The “EndoKnow” and “Lupron1” websites masquerade as communication tools on “how to talk to your doctor” and “effectively treat your disease,” but they are little more than thinly disguised direct-to-consumer marketing tools paid for by TAP, which take your private contact info and disseminate them to the manufacturer along with other “third parties” [see TAP’s privacy policy at http://www.tap.com/privacy.asp]. Beware also any editorial materials bought and paid for by TAP, such as those featured by patient associations to which TAP “donates.”

Of greater concern is the practice by which the drug is peddled. Your doctor may not have told you that in a recent federal lawsuit, TAP pleaded guilty and paid out over a staggering *$875 million* in criminal fines, restitution and civil penalties for their illegal marketing, pricing manipulations, and unethical sales practices to induce doctors to prescribe LupronÃ?®. The suit, brought under the federal Racketeer Influenced & Corrupt Organizations Act (RICO) represents the largest pharmaceutical fine in history. For details, visit your state’s Department of Justice website or start researching the matter by visiting http://www.findarticles.com/p/articles/mi_m3257/is_12_55/ai_82481865.

Lupron�® is not a cure for Endometriosis, nor is it even necessarily a viable treatment option for some women. There is no absolute cure for the disease, but working with physicians who specialize in Endometriosis and treat the illness through the use of modern concepts instead of outdated myths and biased literature from the manufacturer have higher and longer-term success rates than those who put their patients on potentially risky and possibly off label treatment protocols.

See also:

http://groups.yahoo.com/group/erc
http://www.geocities.com/lupronfacts/facts.html
http://www.redflagsweekly.com/letters/letters5.htm
http://health.groups.yahoo.com/group/lupron/
http://groups.yahoo.com/group/LupronVictims/
http://www.endocenter.org/pdf/surgery%20vs.%20gnrh.pdf
http://www.endocenter.org/pdf/PreDiagnosisGnRH.pdf

What your doctor may not have told you is that you DO have a choice in treatments for Endometriosis�make yours an educated one.

[1] Moore J, Kennedy S, Prentice A. Modern combined oral contraceptives for the treatment of painful symptoms associated with Endometriosis (Cochrane Review). The Cochrane Library 1999, Issue 3. Oxford:Update Software.
[2] “Off-Label’ Prescription Drug Use Common.” Forbes Magazine, 05.08.06. Website: http://www.forbes.com/forbeslife/health/feeds/hscout/2006/05/08/hscout532598.html].
[3] “Financial Conflicts of Interest in Research.” Lindsay Hampson, Department of Clinical Bioethics, National Institutes of Health. Website: http://www.bioethics.nih.gov/slides04/hampson.ppt.
[4] Winkel, Craig A. Evaluation and Management of Women with Endometriosis. Obstet Gynecol 2003 Aug;102(2):397-408.
[5] “Surgery vs. GnRH.” Endometriosis Research Center study collection. Website: http://www.endocenter.org/pdf/surgery%20vs.%20gnrh.pdf.

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