A pharmaceutical drug prescribed for endometriosis is being accused of causing debilitating physical and mental damage to thousands of people. Many former users say they’ve had to go on disability services at a young age. Many others blame the drug for the deaths of their sick loved ones. And yet Lupron continues to be offered as a treatment for many conditions.

Along with endometriosis, Lupron (its generic name is leuprolide) is used to treat prostate cancer, precocious puberty, and a long list of other off-label applications. More than 15 Facebook anti-Lupron groups currently exist, some with thousands of members sharing stories of how this drug (a Gonadotropin-Releasing Hormone analog/agonists or GnRHa) altered their lives in a major way.

Lupron was approved to treat endometriosis by the FDA in 1990, with the recommendation of using it for six months, maximum. Endometriosis is a chronic inflammatory disease that occurs when the endometrium grows outside the uterus, where it doesn’t belong. The disease affects one out of every 10 women between the ages of 15 to 49, though there are cases where it happens to younger patients. Finding a diagnosis is challenging, with the average time being six to 10 years. Treatment options offer little in the way of long-term relief, and some of them, like Lupron, make the disease even more unmanageable.

Because of this, many Endometriosis patients are looking to cannabis as a safer alternative and finding the many applications of the plant lifesaving. Stephanie Kerns was told that Lupron was her only non-surgical choice at the age of 19, after her first failed laparoscopy.

“I had my first failed laparoscopy at 17. This surgery promised to make me better. By 19, I was beside myself. I was a college dropout and I couldn’t hold a job,” Kerns says, pointing out that Lupron is the worst thing she tried. “I started Lupron at 19. Doctors wanted to try a second surgery, but said Lupron would work better and shrink the disease down to nothing. I did four long months of this brutal ‘treatment’, but the effects have lasted a lifetime.”

Kerns says that Lupron was the cause of gaining 95 pounds in three months, and that she still experiences structural pain all over because of the intensity of such a quick weight change. She lost the weight once she stopped taking Lupron, but her joints hurt just as much as they did when she quit treatment 20 years ago. She says her bone structure has changed so drastically since Lupron that her face even looks different.

Hot flashes, depression, kidney, bladder, and respiratory infections are just some of the adverse effects Kerns attributes to Lupron. She says that her migraines are much more intense, she craves sugar insatiably, and her immune system has never been the same. If she knew that Lupron was originally used as a chemotherapy drug for prostate cancer, she wouldn’t have tried it, but research surrounding the drug was limited at the time.

“If doctors could have recommended cannabis to begin with, it would have saved me infinite suffering and complications.”

After exhausting all other treatment options, she became a medical cannabis patient, and finds that the plant helps with pain, hot flashes, immunity, and appetite. “If doctors could have recommended cannabis to begin with it would have saved me infinite suffering and complications,” says Kerns. Considering the controversy surrounding the plant, doctors still prescribe it regularly in gynecology. Some critics believe it has something to do with the drug’s recent history of shady dealings and kickbacks.

In 2001, TAP Pharmaceutical Products (a joint venture between Abbott Laboratories and Takeda Chemical Industries that manufactures Lupron) paid $875 million to settle civil and criminal charges for illegally abusing Medicare and Medicaid programs. Sales representatives from TAP would give doctors free samples of Lupron and then help them extract hundreds of dollars per dose from government programs. Employees of TAP were also prosecuted for giving kickbacks to doctors for prescribing Lupron.

Between the years 2013-16 AbbVie (the other manufacturer of Lupron) paid $18 million to over 28,000 doctors in relation to Lupron. The second highest paid doctor on the list is a consultant for AbbVie who conducted trials on children being treated with Lupron for precocious puberty and subsequently concluded that five out of seven of the serious adverse events (including one death) observed in subjects were not related to the drug. Instances of reported bribing and subsequent lawsuits regarding fraudulent marketing practices are carefully detailed on Lupron Victims Hub, a panacea of Lupron information, which was created by Lynne Millican.

Millican, a registered nurse and paralegal, lives with disabilities she holds Lupron responsible for. Now, she devotes her life to educating the world about the potential negative impacts of the drug. Not only does she document every single aspect of their business dealings, she catalogs and provides commentary about the failed class action lawsuits, the disregard of proper drug administration, and tracks all deaths that are GnRH-related. She began writing the FDA in 1992, imploring them to investigate the off-label use of Lupron.

Her letters to the FDA also ask what type of surveillance is being done for women who are given Lupron, citing that their database doesn’t include related deaths. She points to a report that says the FDA was deceived with fraudulent clinical trial data when they approved Lupron for treatment of endometriosis. “Once the FDA was notified by Dr. David Redwine’s 2011 report detailing that Lupron’s manufacturer supplied to the FDA fraudulent data from its endometriosis clinical trials, one would presume the FDA would take immediate and severe action,” Millican says.

“After all, Redwine’s analysis of the trials’ data revealed (among others) that 62.5 percent of women one year after halting Lupron treatment had not returned to baseline estrogen levels, indicating ovarian damage. This is a very serious consequence to women (and to families, and to society), and an issue that needs to be addressed.”

When reached for comment, Lyndsay Meyer, the FDA’s media relations director, says they have a commitment to making sure that all FDA-approved drugs are safe and effective. Using a benefit-risk assessment, they balance the data presented in each marketing application. Drug labels include important safety information that inform prescribers and patients if a drug is appropriate for treatment, and they monitor the safety of drug products after approval.

The FDA relies on voluntary reports from healthcare providers and consumers to help add to the FDA Adverse Event Reporting System (FAERS) database. “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,” says Meyer.

“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.”

She continues, “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.”

Former users, meanwhile, continue joining online forums. Just last year, a three-part investigative story broke on a local news station. Within 24 hours, the station’s Facebook page was flooded with hundreds of stories from Lupron victims. The response was so overwhelming that the station created a separate Facebook page and extended their coverage of the topic.

Patients in other ex-Lupron user Facebook groups are desperate for anything that will make the situation better. For Nichole Malo, resisting the treatment has been a lifelong struggle. Originally prescribed for precocious puberty, Malo was given Lupron at the age of 10. When Lupron was presented as her only option for treatment of endometriosis as an adult, she refused. “I have been diagnosed over the years with fibromyalgia, arthritis, pancreatitis, hypokalemia, osteoarthritis of the cervical spine, sciatica, cervical radiculopathy. Palpitations, anxiety, tremors, teeth decay, eyesight problems, persistent nerve pain shooting all over my body,” Malo says.

As a completely healthy child, without any family history of such conditions, Malo says she only found some peace of mind when she found a Facebook group for “Lupron victims.” To this day, her hormones are out of whack she says, and her anxiety severe. “I feel like there’s so much more I could blame the Lupron for but I can’t prove it, and the Lupron makers will not release what they actually know out of good faith… we need to somehow and some way go through the courts, I believe, before we get real answers,” she says.

“Cannabis is a great gift… using it is really helpful for me on my medical journey. It’s a small win at some hard moments for me.”

Malo is on 25 medications today, in order to stabilize her health problems, and many of those prescriptions cause horrible side effects like nausea and chronic pain. She says that using cannabis helps with the pain, and replaces some of the stronger opiates, allowing her to better evaluate if the prescriptions are working.

“Taking my edibles or oils gives me the chance to do that internal check to see if I’m OK or if I need to pay closer attention to a certain area of my body that giving off a different pain or maybe not giving off pain anymore,” she says. “Cannabis is a great gift the earth has given to us, and using it is really helpful for me on my medical journey. It’s a small win at some hard moments for me.”

Because sufferers of endometriosis are believed to have fewer CB1 receptors in their endometrial tissue, the disease can spread and symptoms can be exasperated. Activating CB1 receptors in the reproductive organs through THC or CBD can alleviate pain. Additionally, terpenes like Beta-caryophyllene (BCP) activate the CB2 receptors, which are found mainly in the brain, immune system, and in female reproductive organs. In one scientific study, BCP reduced the growth of endometriosis in rodents by 50 percent.

CBD and THC are powerful anti-inflammatory agents, helping to reduce pain in endometriosis patients. Hemp is also said to help replenish ceramides in hair after suffering hair loss from Lupron. THC can alleviate nausea and increase appetite, both of which can be symptoms of endo (as it’s often called) and a side effect of Lupron.

Using cannabis not only helps with the many side effects of Lupron, it can replace other medications prescribed to combat those effects, says Eloise Theisen, president elect of the American Cannabis Nurse Association, and founder of the Radicle Health Clinician Network. Theisen works with a lot of patients who suffer from the side effects of Lupron.

“Cannabis can help alleviate some of the side effects associated with the prescription drug such as hot flashes, mood swings, insomnia, headaches, depression, and nausea,” she says. “Patients may be able to reduce these side effects using cannabis alone and avoid having to take multiple other medications to address all of the side effects that can occur with Lupron.”

By Diana-Ashley Krach

September 19, 2019

Diana-Ashley Krach is a full-time freelance writer, author, and journalist, writing for Cosmopolitan, XOJane, Playboy, and more.