Lupron, Thyroid Disease, and the Broken Scales of Justice

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lupron, thyroid and broken scales of justice
Even though women being prescribed Lupron (leuprolide) have (understandably) no clue about its adverse thyroid effects, it is no secret that Lupron adversely affects the thyroid gland. (The same could be said for adverse effects from Lupron on many other organs and bodily systems, but the focus here will be on the thyroid.) For decades, a wide variety of adverse thyroid effects during or following this drug have been reported to the FDA: according to RxISK.org’s compilation of Lupron FDA Adverse Event Reports (‘AERS’, for the years 2004 – 2014), Thyroid cancer, Hypothyroidism, Thyroid disorder, Thyroidectomy, Hyperthyroidism, Thyroid neoplasm, Thyroid function test abnormal, Autoimmune thyroiditis, Thyroid cyst, Blood thyroid stimulating hormone increased, Blood thyroid stimulating hormone abnormal, Blood thyroid stimulating hormone decreased, Anti-thyroid antibody positive, Thyroid cancer metastatic, Biopsy thyroid gland abnormal, Follicular thyroid cancer, Thyroiditis, and Thyroiditis subacute have all been reported (search “thyroid” in “Side effects reported” here; also Open Vigil, which contains FDA AERS for the years 2003 – 2013, can be searched.)

Different Warnings for Different Countries

For decades foreign labels for Lupron have identified “thyroid enlargement” as an adverse event ( i.e. 1998 Australian label for “Lucrin [Lupron]”, MIMS Annual 1998, Australian Edition, page 9-804; also 2010 Danish label – Danish Medicines Agency, Product Resume for “Procren [Lupron] Depot”). As early as 1986 the US product label for the initial formulation of Lupron (5 mg/mL vial, administered as 1 mg daily subcutaneous injections) identified “thyroid enlargement” as an adverse event (1986 Package Insert No. 3626, “Lupron/leuprolide acetate 5 mg/mL. Manufactured for TAP Pharmaceuticals by Abbott Laboratories, Rev[ised] Nov. 1986”; 1992 Physicians’ Desk Reference [PDR] , “Lupron/leuprolide acetate 5 mg/mL”, p. 2310). The US product label for the intramuscular injection of monthly Lupron Depot 3.75 mg (and other depot dosages) likewise identified warnings for thyroid enlargement (i.e., 1995 PDR, “Lupron Depot 3.75 mg.”, p. 2506; 1996 PDR – “Lupron Depot 3.75 mg”, p. 2558.) Between 2004 and 2012, there were 22 reported cases of thyroid cancer, and Lupron was considered “highly suspect” by a number of physician opinions, and according to RxISK.org’s FDA AERS database, there’s been 6 more cases (search “thyroid cancer” in “Side effects reported” here).

But, despite this history, all thyroid adverse events have been removed from the current labels of US Depot formulations of Lupron, and no thyroid warnings have been identified since the mid-2000’s – i.e., the current Lupron 3.75 mgs product label as well as the current labels for other depot dosages no longer contain any mention of thyroid adverse effects. The daily 1 mg formulation of leuprolide continues to identify warnings of thyroid enlargement and thyroid nodule, and foreign labels for Lupron continue to identify adverse thyroid effects, but the labels for US Lupron Depot formulations (which are prescribed the most for women with endo and fibroids) are devoid of any warning.

In the Courts

It is worthwhile here to revisit the atrocities committed during the only Lupron lawsuit to make it to trial (Karin Klein v. TAP/Abbott, Case 2:08-cv-00681-RLH-RJJ, 2011) – many prior lawsuits having been quietly settled with secrecy agreements. Karin Klein, at age 17, was prescribed Lupron Depot 3.75 mgs in 2005 when Lupron’s label no longer contained the prior-listed warnings about adverse thyroid events. Karin developed, among others, chronic autoimmune Hashimoto’s thyroiditis. Belatedly learning of Lupron Depot 3.75 mgs’ prior US label warnings of adverse thyroid effects, as well as the prior and current similar warnings in foreign labels, Klein sued for failure to warn.

The judge at trial refused to allow the jury to learn of Lupron Depot’s pre-2005 US labels warning of adverse thyroid effects; the judge refused to allow the jury to learn of Lupron’s past and current foreign labels identifying adverse thyroid events; and the judge refused to allow the jury to learn of published medical literature identifying Lupron’s adverse thyroid effects (See Judge’s rulings, “Document 265, filed 07/25/11, page 13 of 40”, which can be found on p. 101 in this document). The judge would only allow the jury to learn of the 2005 US label. Moreover, Abbott’s mendacious defense medical “expert” stated under oath that “it was absolutely biologically impossible for Lupron to affect the thyroid gland. No textbook, no article has ever supported that contention. It’s simply biologically impossible.” (See “Page 20 of 131” here). A simple PubMed search shows this “expert statement” to be absolutely false – and this is without-a-doubt perjury (here, here, here and here). The first published report that “demonstrate[d] the association of thyroid disorder with leuprolide” occurred in 2000 – five years prior to Klein’s Lupron Depot prescription. Rhetorically speaking, exactly how does a paid “medical expert” get away with outright perjury concerning Lupron Depot’s – or any other drug’s – known risks?

This court’s curious restriction of limiting disclosure to only the 2005 Lupron Depot label (devoid of any thyroid warning) created the illusion for the jury that there were NO thyroid adverse effects from Lupron Depot for Klein to have been warned about — and so by a legal sleight of hand, Klein’s claim of “failure to warn” was made to disappear. The jury, unknowingly dis-informed and ‘educated’ in misinformation only, believed that it was ‘biologically impossible for Lupron to affect the thyroid gland’, and the jury found against Klein and found in favor of the drug company.

An appeal – bewilderingly – resulted in the Circuit Court making false statements and misstating facts. As argued on appeal by Klein’s attorneys:

“[Klein was] entirely shackled in the evidence she was allowed to present. It is particularly galling to have qualified (and expensive) expert witnesses on hand to testify, only for them to be shut down before the jury and precluded from offering competing expert opinions. The pattern shown by the record [of the Klein trial] is deeply disturbing. Virtually every discovery and evidentiary ruling, and other orders of significance, went for one party [TAP/Abbott and never for Klein]. … Such a one-sided proceeding was not the fair trial our system demands.” The multitude of rulings against Klein’s request for admission of evidence can be found delineated the afore-mentioned in “Document 265, filed 7-25-11”.

But the Circuit Court, in a 2-day deliberation, concluded: “… The district court did not abuse its discretion in excluding the challenged Lupron labels because they all contained information regarding the side effects of different formulations of Lupron, rendering them insufficiently relevant, unduly prejudicial, and likely to confuse the jury.” Here the Circuit Court misstates facts and conveys the opinion that “the pre-2005 US Lupron Depot 3.75 mg label for endometriosis” is a “different formulation” from “the 2005 US Lupron Depot 3.75 mg label for endometriosis”. This is utter hogwash from a high court – “Lupron Depot 3.75 mgs” is identical to “Lupron Depot 3.75 mgs” regardless of the year of the label. And it should not be terribly difficult for anyone (including the Court) to comprehend that the drug comprising the initial 1 mg. daily-injected subcutaneous Lupron was subsequently put into a “depot” (“long-acting”) ‘delivery form’, allowing one intramuscular injection to slowly deliver the same drug — Lupron – over the course of one (or three) month(s). The courts had access to the 2010 Danish label (Klein v. TAP/Abbott, Document 175, filed 06/12/11) in which it is stated “Leuprorelin [leuprolide] acetate is released at a constant rate over a period of 4 weeks (3.75 mg) or 12 weeks (11.25 mg) … which is equivalent with what is seen with a daily injection of 1 mg leuprorelin acetate.” (To date, I have not located that same statement in a US Lupron label.) This appellate court concludes that “Klein has not even remotely established that the district court exhibited such a high degree of favoritism or antagonism as to make fair judgment impossible.”

Denied her right to a fair trial a second time, Klein petitioned the US Supreme Court. One would (and should) assume the Supreme Court would inherently recognize the serious ramifications and public health impact of a case (any case) where perjury of the known dangers of a drug was committed by a defense expert (effectively hiding this information from the jury and ensuring a defense ‘win’), and where a Circuit Court completely misstated facts (upon which it had relied to deny Klein’s appeal). But, in fact, the denial of a plaintiff’s right to a fair trial, the denial of a jury’s right to truthful and accurate expert medical testimony, and the denial of society’s right to expect that court rulings will be based on authentic factual information were all issues the US Supreme Court deemed unworthy of review.

Broken Justice: Precedent for Medication Adverse Events Cases

These circumstances resulted in a devastating miscarriage of justice – not just for Karin Klein, but for all Lupron victims – and to society at large as well. What kind of precedence could this Klein verdict have upon future litigation – with this or any other drug? In fact, lawyers throughout the US, with potential plaintiffs seeking redress post-Lupron, were closely following the Klein case, and had Klein prevailed the floodgates of litigation were poised to spring open. But by securing a defense ‘win’ via, in my opinion, a multitude of highly questionable actions, those floodgates were slammed shut. (In May 2015 an RN disabled post-Lupron filed a lawsuit, and this case is presently making its way through the court system.) At least a few ethical and powerful legal experts should be examining the events in the Klein case – it could (and should) become renowned as a classic case of injustice personified. (Links to additional court documents and further details on the Klein case can be found at bottom of page, left column).

What does it mean when a young woman’s health and life are irreparably damaged and there is no recourse? How does a disabled victim fight against a system that has clearly indicated it is obfuscating and is the antithesis of justice? How does a society ensure that truth prevails, and harmful effects of drugs are exposed rather than shielded?

Recently, in attempts to achieve transparency in clinical trial data, many drug companies have put their clinical trial data online. The endometriosis clinical trial data for Lupron 3.75 mgs remains under a court seal – ensuring this data will never see the light of day.

There are many, many questions, and many, many victims, but as of yet – there are no substantive answers.

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13 Comments

  1. It makes me sick to think that the makers of Lupron continue to get away with everything. I made the mistake of listening to my doctor who insisted that Lupron was much safer for me to take than to have a hysterectomy. I had a history of endometriosis and fibroids. I took the series of shots and after the first one immediately started having chest pain and my blood pressure increased. The gynecologist said it was not related of course even though it was IMMEDIATELY after the first shot. I went through a complete workup and all was fine. From that point I started having bone pain, especially in my lower legs bilaterally and in my back. That was over 15 years ago and today I am completely disabled by it. Prior to Lupron I simply had gynecological issues that would have resolved with a hysterectomy which I ultimately had. Instead I developed severe osteoporosis and had many broken bones. This was before they prescribed anything to piggy back with the lupron. Guess they learned that was a mistake. I try to warn people about how dangerous Lupron is. I tell my doctors, but they all just say, hm ok.

  2. I was prescribed Lupron to help me with my severe endometriosis. My doctor told me ‘not to Google Lupron and stay away from those Lupron websites, they’ll just scare you’. I took the shot for four months but I didn’t like the way it was making me feel. Two months later, I was dx with hyperthyroidism. (I’ve never had anything other than a healthy thyroid. I am 51 years old.) The cause of my hyperthyroidism was because I had developed Graves Disease. My GP says that for every 100 patients, he will see 1 with hyperthyroidism….people with HYPOthyroidism are very common. I am now on Tapazole. After two months, my TSH has gone from 0.01 to 1.4. It used to be 5.0 when it was healthy. The only doctor who would acknowledge that there MIGHT be a connection (because really, I develop Graves RIGHT AFTER taking Lupron?? Kind of a coinky dink, I think) was my GP. My endocrinolgist acts like she’s never heard of that before. My gynecologist doesn’t even know yet. I’ll be sending him this article and taking copies to my other doctors. They can’t deny it now. It’s been a difficult and stressful time.

    1. Tracey,

      After sending and giving copies of this article to your gynecologist and other doctors, please consider leaving another comment describing their response to the information. (Presentation of negative Lupron information to prescribers and other doctors is something that can be quite difficult and stressful to them!) And unfortunately it *is* possible to deny Lupron’s role in causing problems.

      You and other readers may be interested in reading the comments by Dr. Abend in her expert testimony on behalf of my 1992 lawsuit (medical malpractice). While these comments were written in 1997, and there is now considerable acknowledgment about Lupron’s role in causing memory loss, the essence of the statement is still very relevant. The following are pertinent excerpts (and entire testimony can be found @ http://lupronvictimshub.com/home/AbendsExpertNote.pdf ):

      ” … Doctors who prescribe Lupron are denying people the accurate information they need in order to make an informed decision. Once people become ill on Lupron, these physicians are denying the temporal relationship between Lupron and the onset of symptoms. They even deny information in respected peer-reviewed medical journals. For example, two studies reported memory loss with Lupron occurring in 72% and 75% of the studied populations. Both studies were published in the Journal of Assisted Reproduction and Genetics, and Fertility & Sterility respectively. The percentages reported are quite high. In fact, if an individual does not experience memory loss with Lupron that individual is in the minority. Yet, doctors who prescribe Lupron are continuing to deny that Lupron causes memory loss. Doctors who prescribe Lupron are also denying that Lupron can cause other side-effects that have already been acknowledged in the medical literature and printed in the package insert. They deny the correlation of side-effects while on Lupron. They deny the correlation when one stops taking Lupron and the side-effects persist….”

  3. Oh Mon Dieu. I think I have FINALLY found the answer to my demise after finding this website. I was diagnosed with Endometriosis in 2011, given the Lupron shot in February of 2012. Starting in 2014, I started to feel absolutely lousy. The list started off with fatigue, sudden weight gain and puffy eye lids after waking and now has turned into a laundry list of symptoms. My gut told me it was the birth control shot and told myself to stop treatments (last shot administered January 2015) and it took until May 2016 for my first period to start again. I bled nonstop from May- August, and now nothing again for the last 5 months. During these past 5 months my symptoms grew far worse, leading to blackouts. Tests results are now pointing to some sort of Endocrine Dysfunction, possibly secondary hypothyroidism or something of the like; waiting on more test results. Wow. Just wow. Everything I have read reinforces that I am not crazy!

  4. Gynecologists have to stop prescribing this poison. After I slowly deteriorated in front of my doctor’s eyes month after month, complaining of pain in my body, then my inability to walk unassisted, and finally explaining to my doctor that my life had totally been turned upside down by the never-ending pain, she didn’t believe it was the Lupron. Only several months prior I was a strong, healthy woman in my early 30s.. I turned into a lump of cells begging for relief. My doctor knew exactly what was wrong with me. But if she admitted it, she couldn’t ethically give it to any other patient. So she turned her back on me. Doctors must stop this charade and recognize that this drug is permanently ruining lives. They responsibility is on them as much as on AbbVie and the FDA.

  5. I would love to know more about the RN and her case. Especially that it is going thru the court system. I am also a lupron victim. I had problems right away. I was diagnosed hyperthroid in 2010. Had lupron injection 2006. I am still suffering the irreversible effects. I don’t know if you have looked at the petition sites but there are several women saying the same thing.

    Not only do I want them to stop giving lupron
    I want them to give us a diagnosis. Not fibromyalgia so Drs know that we are suffering due to this chemo drug. I’m not a baby with pain. I don’t have a low pain tolerance. I hurt from this injection. But I have really enjoyed this website. It’s nice to know that I’m not crazy. However, my pain management dr said he has seen several women in his office with a history with being given lupron. It was the first dr I’ve ever heard actually say something against lupron. He is a spine, back guy but treats fibromyalgia but also spinal stenosis, bulging discs and degenerative disc disease. I also have osteopenia. I am 38. I’m told I’m too young for all these issues but I know it’s from lupron.

    I am really concerned because now several gynecologists think not only is it a cure for endometriosis but now given without a diagnostic laparoscopy. Also many insurance companies and doctors won’t do a hysterectomy without at least 2-3 rounds of lupron. I had to fight to prove I wasn’t doing another round. It ruined my body. It’s poison. Even in prepping the doctors were threatening to cancel surgery and give me lupron. I was also worried they would give me lupron post surgery. I wrote on a piece of paper refusing lupron. I refuse it and signed and gave to hospital and took a pic with phone. Because that happens too. I actually think that not only do we fight courts but it’s time to start advocacy with our lawmakers. I am learning about advocacy and the best way to speak to legislature. But we need to do this as well.

    I have learned from some anti (anti depressants and psychotics) proving that drug companies not only pay Drs to change studies but also the metadata and that they believe it’s happening in other drugs.

    Not only have I gone thru the hell from lupron but lyrica as well. It’s the same thing. Look up Scott Rubein to see that mess. I think that’s what they need to do is prove the doctors are lying under oath, under research. FDA doesn’t work like we think it does. We need a better check and balance system. I know I sound conspiracy theory crazy lady but it happens over and over again. Look up the antibiotics florequines and cipro. I ask myself why aren’t their lawsuits against lupron? Not only aren’t there lawsuits however are for zofran but we are looked at like we are crazy or worst drug seekers. Not only do we need help with lupron but endometriosis needs help. We need to have it recognized as a disability. Like I said I am learning about advocacy because this has to change.

    1. Hi Jen, you’re absolutely correct, this has to change and because so few docs recognize the side effects of Lupron, it’s still given out readily. Having said that, one way to force the change is via advocacy and more specifically, speaking out, telling your story. Would you be interested in sharing your personal experience with Lupron in the form of a blog post? That way, other women will see it and perhaps think twice before accepting the drug. For those who are already suffering, telling your story will help them know that they are not crazy, add to the body of case studies, and allow researchers and other women to identify patterns. Here’s the link to contact us if you are interested. http://www.hormonesmatter.com/write-for-hormones-matter/

      1. I wish I knew about all this evidence in 2005 after taking Lupron for 6 months and then a green 11 years later to retake it for two doses at the age of 38 this stuff is killing me it’s nice to know I’m not alone and not crazy

  6. A deliberately misinformed, bamboozled jury found against an individual, and in favor of a multibillion-dollar pharmaceutical company? Unheard of!
    Surely Karin Klein had better things to do with her precious resources than to kick this hornet’s nest, facing further insult to injury, unless she felt compelled to defend her fundamental human rights. Undoubtedly these results aimed not only to teach her how helpless she really is, but also send this message to the multitude of other injured parties seeking remedy, so that they may all crawl under a rock together. If only all Lupron victims’ permanent disabilities could be made to disappear as easily as Karin’s claims of failure to warn.

    Pussyfooting around the wording of labels, be they in English or any other language from countries where the systems support their citizens efficiently, drew attention away from an important issue: Karin Klein did not suffer from chronic autoimmune Hashimoto’s thyroiditis, among other debilitating complications, before taking Lupron Depot 3.75 mgs, but she does now. She is now permanently disabled. Had she known this drug might harm her, she would never have taken it: No reasonable person would take Lupron or any other GnRH-a, if they were adequately informed of their short- and long-term consequences, no matter what the “potential” benefits.

    Is the market really an appropriate testing ground to identify at which dose Lupron’s active agent will generate adverse thyroid events, among others, disregarding its specific delivery mode, direct or slow release? What possessed TAP/Abbott to remove their prior warnings of adverse thyroid events, among the long list of life-altering complications this drug is known to cause, declared and undeclared alike? What evidence did they have to conclude the particular concern of adverse thyroid events was no longer worth warning of? Moreover, will TAP/Abbott see their way clear to reinstate this warning now that Ms. Klein provided proof to the contra?

    Do TAP/Abbott really possess the capabilities to let adverse events reports or related claims for compensation disappear, simply by denying them indefinitely? Perhaps even their shareholders would object to Ms. Klein’s treatment, if not on ethical grounds, then certainly because this approach cannot be sustained over the long term, no matter how shrewd their increasingly expensive legal defenses. Hopefully this singular example among a multitude of claimants did not shut the floodgates of litigation at all, but merely put another wedge into a crack that was already wide open. Legal teams worldwide must tailor their approach accordingly, rather than being deterred by these results.

    Perhaps shareholders in pharmaceutical companies will recognize the wisdom in publishing clinical trial data online to mitigate their own potential losses. After all, companies that deceive their customers are dishonest across the board, with all their stakeholders. Should shareholders demand transparency in clinical trial data where they currently invest or should they aptly look for safer long-term returns on their investment elsewhere; in companies who apply this strategy autonomously?
    Scrutinizing clinical trial data independently might be the way of the future to assure drug safety, if we reached a new level of standards, where FDA approval really waves a red flag to signify ‘caution’, rather than the red tick to signify the safety that we have all come to expect? Or must we translate all drug labels in all available languages to be convinced?

    At least not all of Ms. Klein’s brave efforts went astray, and not all of her claims disappeared entirely, as we can read about them here. Hopefully this information will reach some unsuspecting patients in time; before they too join the long queue of devastated Lupron victims, who claim this GnRH-a has permanently ruined their health and taken everything they valued. For now, at least, they are warned to expect the unexpected, and that the law will not protect them.

  7. How many more lives will be ruined, how many more people killed with this horrible drug? It is sad what is allowed to FDA and Abbott in USA. Money is the only important thing, our pain, destroyed families and lives mean nothing. I wish with all my heart that all doctors who took part and approved this poison for any use could be given Lupron. Maybe than they would understand the hell that all of us who were given Lupron are going through.

  8. ” foreign labels for Lupron continue to identify adverse thyroid effects”
    Are they identifying adverse effects for the same slow release formulation that Klein had taken?

    “which is equivalent with what is seen with a daily injection of 1 mg leuprorelin acetate.”
    Equivalent amount or the exact same drug?

    1. Caryn,

      The statement “which is equivalent with what is seen with a daily injection of 1 mg. leuprorelin acetate” is taken from the 2010 Denmark label. Lupron is also called “leuprolide acetate” (US) and “leuprorelin acetate” (Europe) – and whether you are prescribed the daily Lupron (“leuprolide/leuprorelin acetate”) or Lupron Depot (“leuprolide/leuprorelin acetate”), the drug you receive is “leuprolide/leuprorelin acetate”. What this statement implies is that if one were to receive injections of the daily Lupron 1 mg. for 30 days, serum (blood) concentrations of leuprolide/leuprorelin acetate would be the same as if that patient had rec’d only one injection of the monthly (3.75 mg) or one injection of the 3-month (11.25 mg.). The daily Lupron (“leuprolide/leuprorelin acetate”) was put into “microspheres” to create the long-acting “Depot” formulations (“leuprolide/leuprorelin acetate”), and these microspheres are alleged to dissolve slowly and evenly throughout the month (or 3 months). There are some differences in the ‘additives’ to the 2 types of formulations – i.e., daily Lupron contains “benzyl alcohol” which the Depot does not, and Lupron Depot contains “D-mannitol” which the daily Lupron does not, however the drug itself is the same in the daily and Depot. (Drugs having differing ‘additives’ but the same drug can be readily seen in any pharmacy isle when comparing a brand drug’s list of ingredients to a generic version – the drug itself is the same, but the excipients or additives can and do differ.)

      It is not terribly easy to obtain foreign labels, so all adverse events (past and/or present) from all countries cannot be definitively addressed at this time. A HormonesMatter poster (Karen) reported that in November 2015: “In Europe the patient information leaflets changed. It now includes thyroiditis as a common side effect for women. …” (http://www.hormonesmatter.com/lupron-estradiol-mitochondria-adverse-reactions/). The statement “foreign labels for Lupron continue to identify adverse thyroid effects” is based upon this latter comment, and in addition, a Denmark label (2010) and Australian label (1996) list adverse thyroid events – and these latter 2 labels detailed the long-acting Depot formulations.

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