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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This article was published originally on January 20, 2016.
I was given (3) shots of Lupron, 3 weeks apart because heavy periods were misdiagnosed.
I ended up reading an article in “SELF” magazine titled “medical mishaps.”
I took it to my OBGYN and a specialist.
They finally ordered a TSH test and it was dead.
Lupron threw me into early menopause at 40.
It’s NOT for Hashimoto’s thyroiditis which I now take Synthroid for.
My entire pregnancy I had undiagnosed Hashimotos and now my son has ADHD. (It’s 💯 connected)
Judge would not allow the article to be in the courtroom and blocked every piece of evidence while defense entered “doctored message,” with no objection from my “obviously paid off attorney.”
I had an all male jury on an OBGYN malpractice.
To this day, my uterus is so shrunk, it’s all stuck together.
They put me through hell and now my son.
There’s no justice when it comes to Connecticut corrupt medical society and health dept.
I diagnosed my own Hashimotos and Lupron isn’t any part of addressing it.
It’s a malpractice that this test is denied during pregnancy.
Like you, at the age of 38 my body was thrown into menopause after my second monthly injection of Lupron. I was on this protocol for a year (2005-2006) after receiving a diagnosis (and being hospitalized for a ruptured ovary) of stage IV endometriosis. The monthly injection was advised to me in an effort to repair and maintain my reproductive organs with the anticipation of achieving fertility and ultimately a successful pregnancy. In 2005, there was very little information available on Lupron nor was the practice of “Google-ing” for information, observations, insights and opinions a common one. Now at 54 years of age, infertility was never acheived, hysterectomy at 45 years of age brought no physical relief and my body can feel like it’s a 100 years of age at 54. I have found fasting (specifically “dry” fasting) for 48 to 72 hours to be the ONLY thing to relieve most of my symptoms (muscle fatigue, achy joints, GI issues, autoimmune disorders, etc.). Its a desperate measure, I know, but it is by far the most effective at relieving symptoms QUICKLY and without additional medications. I’m amazed that you found an attorney willing to take your case. No attorney in the state of Arizona will touch Lupron. I’ve been advised to wait until other cases that are currently in the legal pipeline (not sure if there is any truth to that) to win before pursuing legal action. If more men that were treated with Lupron (for prostate cancer) would come forward (and they are out there) to discuss their conditions related to this drug (especially when the jury is an all male jury), I’m convinced more cases would be awarded in our favor. I’m not holding my breath though.
I suffered from heavy bleeding from a fibroid and was told while at the doctor I would be given a Lupron shot. Since I didn’t even know what a fibroid was or a thing about Lupron I said I needed time to do some research. I had known of a handful of women who had a similar sounding birth control shot and all had bled for months and was concerned. I soon received a letter from same doctor I had been dropped for non-compliance. It was clear they expected me to trust their recommendation but no one knows my body better than me and I had reservations, plus I expect to have an opinion in my own health care. My choices were drugs and surgery, surgery and drugs. Long story short I had the fibroid embolized against medical advice and have been dropped for non- compliance more than 10 times. Interestingly, the fibroid shrank by almost 90%, bleeding immediately stopped and without any hormone therapy. To this day I have my uterus. Had I listened to the recommendations I would be surgically altered and suffering results of irreversible hormone treatment. I was appalled at women’s healthcare and it’s doctors at the helm. Far different than in my child bearing years. One must be very, very careful. Now I question every recommended procedure. Be it from a dentist or a doctor. It seems their financial interests are more important than my good health. Sad, but true.
Glad I found this site and article. Does anyone have any resources for people who have experienced this “damage”. Either legal or medical? I always assumed my thyroid issues were the result of either a decade of birth control or perhaps radiation during a period of a lot of dental work in a short amount if time. I never thought that my six, monthly Lupron injections at age 31 could have been the culprit. I’m so angry with myself for the unsuspecting patient I once was. Has anyone healed themselves from this? Or even know where to start to detox?
For what it’s worth, a petition is still be circulated, receiving signatures and countless testimonies from women and men. Thank you Lynn for all your years of dedication to this. It’s greatly appreciated.
Reading this is so difficulting knowing all this drug has taken from me .
The rebellion comes when the injustice is perceived …. The biggest mistake rulers can make in this country, whether they have robes … money or executive suites, is to think that these injustices are not being registered in the minds of people. — Ralph Nader
We live in a society where corporations of every ilk have rights over the majority. Binding Arbitration laws (sic) keep consumers, AKA citizens, from going after the junkyard science and engineering in almost every service and product produced by the Titans of Toxicity: US businesses, from Dow, to Monsanto, from Unilever to Pepsi, from Ford to Home Depot, et al.
Finally, consumer arbitration is a strong and effective dispute resolution tool if both sides knowingly and voluntarily agree to it after a dispute has arisen or when equal bargaining over terms is present. If the knowing and voluntary use of ADR provides consumers and businesses with quicker and less expensive methods for resolving disputes, true justice will have been achieved. Justice does not follow from
a situation where consumers are forced to adhere to an arbitral forum and process that they would not have chosen once the dispute arose. A coerced forum fosters the perception, which may be reality in some instances, that consumers are being treated unfairly. Even those who actively promote the
use of ADR may one day see the negative consequences of the coercion, through an exploitation of the goals and purposes of the ADR movement, of individuals in consumer transactions.
–end quote —
Let’s not even get into jury nullification laws, our rights as jurors to nullify wrong and hateful judges foisting unjust sentences on individuals and giving a green light to the corporate junkyard felons.
One of my go-to environmental heroes is Tim Christopher, and his trial highlights our rights as citizens to have the higher moral hand when confronting bad judges, bad government and the prostitutes of corporate fraud, greed and toxicity:
The trial and sentencing of Tim DeChristopher highlights the conflict between the people of the United States and the corporate-government that protects the privileged. In his pre-sentencing statement (republished below) Tim told Judge Dee Benson that the judge was making a choice: “The choice you are making today is what side are you on.”
Tim brought out the corruption of leases of public lands by the Bureau of Land Management, an agency with an ugly history of corruption, and how in this bidding the oil companies expected to get the land at the cost of pennies on the dollar. For the lands Tim did not bid on the average price was $12 an acre, for the one’s he did bid on they were $125. That number rose to the higher levels because oil companies knew that even at the higher price they would make tremendous profits. These public land leases occur for a wide range of corporations and are another example of massive corporate welfare that robs the American people of their public resources, while causing tremendous environmental damage and funneling wealth to the wealthiest 1%.
The connection between corporations and government was highlighted to Tim early in this prosecution. One day before he was indicted the Associated Press called him to tell Tim he would be indicted. The AP reporter had known about it for weeks because an oil and gas industry lobbyist had told him. Evidently the prosecutor’s office was keeping his colleagues in the corporate world well informed about their plans to punish DeChristopher for spoiling the illegal lease auction.
Tim also brings out the twisted nature of the rule of law in a government corrupted by corporatism, saying: “The rule of law is dependent upon a government that is willing to abide by the law. Disrespect for the rule of law begins when the government believes itself and its corporate sponsors to be above the law.” The rule of law is twisted by government often working hand in glove with corporate interests in foreign and domestic policy. When Judge Benson ruled early in the trial that Tim could not show the jury how his actions prevented a greater harm, i.e. preventing an illegal auction and preventing environmental destruction, the judge essentially ruled that the violation of the rule of law by the government in cahoots with the oil companies was not something the jury should know about. Tim told the judge at sentencing: “I agree with the founding fathers that juries should be the conscience of the community and a defense against legislative tyranny.” The judge did not want the jury to have that power.
On civil disobedience Tim said: “the rule of law was created through acts of civil disobedience. Since those bedrock acts of civil disobedience by our founding fathers, the rule of law in this country has continued to grow closer to our shared higher moral code through the civil disobedience that drew attention to legalized injustice. The authority of the government exists to the degree that the rule of law reflects the higher moral code of the citizens, and throughout American history, it has been civil disobedience that has bound them together.” Civil disobedience has always challenged the unjust status quo – whether it was slavery, Jim Crow, women not voting or the crony capitalism Americans confront today.
So, we have given up our power of the people by not participating in our government, in our own governance. Participatory democracy is the only way we can put fire to the feet of the court system and the Abbott’s and Merc’ks and Exxon’s and Monsanto’s and Dow’s of the world.
I was on 30mg of Lupron for 16 years. Many symptoms but the bottom line is I now cannot walk. My legs have atrophied and I have lost all muscle in them.
Why for so long?
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.
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.
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….”
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!
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.
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.
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/
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
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.
Jacqueline, what a fantastic and prescient comment. You seem to know a lot about this case. Would you consider writing a post for us about this and/or any other topic that you find interesting. We rely entirely on volunteer writers and are always in need of smart folks to write for us. You can reach me here: http://www.hormonesmatter.com/write-for-hormones-matter/
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.
” 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?
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.