13 Investigates


More women come forward with complaints about Lupron side effects

Posted at 11:13 PM, Feb 11, 2019
and last updated 2019-02-12 02:23:28-05

LAS VEGAS (KTNV) — A debilitating disease that affects in one every ten women is still without a cure.

13 Investigates launched a series of reports 10 years ago about a medication many women say does more harm than good. Now, new women with new stories of devastating side effects wonder how many more will suffer before the government takes action.

"I was diagnosed with endometriosis officially in November of 2017."

Becky Noback's doctor told her surgery was the best option to deal with her disease.

"And I was prescribed Lupron post-surgery to sort of shut everything down following the surgery to make sure that everything healed properly."

Lupron is a hormone-altering drug that in women essentially throws the body into menopause. But Becky says it was that and much, much more.

"If I had known that it was between the side effects of Lupron or endometriosis pain, I definitely would have preferred the endometriosis pain because the side effects from that medication were just absolutely awful," Becky explains.

RELATED: Are you suffering from Lupron side effects?

Side effects like pain in her joints that's so bad, some days the 28-year-old can't get out of bed.

"It's in my hip one minute and then it shoots down to my knee," says Becky. "It's just this whole upper thigh pain. It's just terrible."

Becky was prescribed Lupron just over one year ago.

But I've been hearing from patients with the same issues for more than a decade.

"I have pain in my chest and in my ribs, the bone pain." said Rachelle Fenner. "I have severe pain in my neck and shoulder," said Mary Orseno.
Lupron was originally approved in the 1980s to help men with advanced prostate cancer live longer. But it doesn't work for dying men, and it has significant side effects. That's according to two studies published years ago in the journal of the American Medical Association.

In 1990 the FDA approved it as a pain reliever for women with endometriosis. But it's so toxic it's not recommended for more than 12 months in a lifetime.

I spoke to renowned endometriosis expert Dr. David Redwine in 2009.

"Lupron does not make endometriosis go away so the cure rate with Lupron is zero," Dr. Redwine explains. "So if you take the rate of essentially 100% side effects and compare that with a zero-percent cure rate, I think it's clear that the risks and side effects far outweigh the benefits."

The FDA currently has over 25,000 adverse event reports for Lupron products including more than 1500 deaths. Reactions include suicidal thoughts, stroke, muscle atrophy and debilitating bone and joint pain.

But just like the patients I talked to a decade ago, Becky says she wasn't warned.

Darcy: "What was told to you as a patient?"Becky: "I was expecting sort of regular birth control side effects. Like acne, maybe a little bit of weight gain, mood swings. But it was all of those things just tenfold." AbbVie, the company behind Lupron, said in a statement Lupron's "...safety profile is well documented in the prescribing information and understood by prescribing physicians."

Amy Courtney says that was not her experience.

"I never wore glasses before Lupron," says Amy.

Vision loss is a known side effect of Lupron but Amy, who took it was she was just 13 years-old, was never told of that risk.

"As soon as the first round of injections, within the first 6 months, I needed glasses," says Amy.

To this day, she still suffers. She's created a support group here in Las Vegas for others like her.

"I fell into a really bad depression. And bone issues, joint pain, and this has been going on for 20 years. It has not stopped."

Several changes were made to Lupron's label after our 2009 investigation--such as warnings about risk of thromboembolism, loss of bone density and convulsions.

All that was news to Becky.

"I think that it's absolutely abysmal and frankly horrific that nothing has been done," says Becky.

AbbVie continues to stand by Lupron pointing to clinical studies published in medical journals. And the company provided the following statement:

Lupron has been available in the U.S. for more than 30 years. Its safety profile is well documented in the prescribing information and understood by prescribing physicians. AbbVie regularly monitors and reports to appropriate regulatory agencies new safety information on an ongoing basis to ensure that our label contains accurate and up-to-date information to assist physicians and patients.

Orilissa’s clinical trial program is the largest endometriosis Phase 3 study program conducted to date. Data demonstrated Orilissa significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex. (see data publications - NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa1700089 and Obstetrics & Gynecology - https://journals.lww.com/greenjournal/Abstract/2018/07000/Long_Term_Outcomes_of_Elagolix_in_Women_With.22.aspx).

The FDA approved Orilissa under priority review, which is granted to medicines with the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.

Orilissa works in a different way than Lupron. As a GnRH agonist, Lupron completely suppresses ovarian sex hormones in the body. As a GnRH antagonist, Orilissa partially lowers the level of ovarian sex hormones in the body in a dose-dependent manner.

The FDA provided the following statement:

Information on the risk of psychiatric events and convulsions was added to the prescribing information for the leuprolide products indicated for central precocious puberty in May 2017.
The FDA is committed to making sure FDA-approved drugs are safe and effective. The FDA bases approval decisions on a benefit-risk assessment of the totality of the data presented in each marketing application. Important safety information is presented in the drug label to inform prescribers and their patients of the drug’s side effects to inform whether the drug is appropriate treatment for the patient. After approval, FDA monitors the safety of drug products, including the frequency and severity of reported adverse reactions, through a variety of sources, including its MedWatch [fda.gov] program. Regulations require manufacturers to report adverse experiences to the FDA, and the FDA also relies on the voluntary submission of MedWatch reports from health care professionals and consumers to help detect problems with marketed drug products. The information received from reports of adverse drug experiences is added to existing data in our FDA Adverse Event Reporting System (FAERS) database, and the collected reports are continually monitored for emerging safety patterns.

FDA has monitored the safety of Lupron since its original approval in 1985 and subsequent approval for use in women for treatment of endometriosis in 1990. We continue to review reported adverse events associated with Lupron in men and women, as well as children with precocious puberty, and take actions as needed. For example, in 2001, we approved changes to labeling concerning concomitant use of norethindrone acetate in women using Lupron for treatment of endometriosis, based on reviews of safety data. Between 2010 and 2013, the Lupron drug label was updated to include new safety information on the risk of thromboembolism, loss of bone density and convulsions, respectively. FDA continues to monitor the safety of Lupron and will take any necessary regulatory actions as appropriate. Based on the available data, FDA’s determination is that the benefits of Lupron outweigh its risks when used according to its approved labeling.

Lupron and Orilissa are different classes of medications. Orilissa was approved based on its own trials and marketing application that showed its benefits outweigh the risks for the treatment of endometriosis. As with all medications, FDA continues to monitor the safety of Orilissa in the postmarketing setting and encourages health care professionals and consumers to report any adverse experiences with Orilissa to the MedWatch program.


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