Dozens of people are bringing forth lawsuits against GLP-1 RA drug manufacturers over adverse events
Plaintiffs suggest that they have not been properly warned regarding side effects such as gastroparesis, ileus, and other complications.
This month a hearing is underway regarding lawsuits tied to GLP-1 RA drug makers Eli Lilly and Novo Nordisk and dozens of patients, in which it is alleged that patients were not properly warned of serious risks regarding these medications.
Talk of lawsuits have been going on the past few years, but it’s this month where a federal judge in Philadelphia is hearing the lawsuits. Although the lawsuit covers plaintiffs from various states the lawsuits were collected together due to common elements.
The allegations are things that we have heard before such as incidences of gastroparesis (stomach paralysis), ileus (intestinal blockage/paralysis), pancreatitis and even gallbladder removal in some patients.
Those interested in the lawsuits and legalese can read it for themselves through a document contributed by Law&Crime.
I have not read through anything but the first few paragraphs, although to reiterate note again that plaintiffs are alleging that they have not been properly warned of more serious side effects, only being told of minor gastrointestinal issues such as nausea, vomiting and diarrhea, and stomach pain:
In some of these cases plaintiffs allege that their gastrointestinal issues persist even after discontinuing the medications, likely meaning permanent harms related to these medications.
Some of these stories can be found in a recent USA Today article, which includes a woman named Monica Church who began feeling nauseated while using Ozempic. But after her dosage was increased she couldn’t keep food and drinks down even after discontinuing the medication, eventually having to be hospitalized because of gastroparesis.
There’s also a man named Bob Tuttle who seemed to have taken the medication for two years for his diabetes, eventually suffering a severe case of gastroparesis that still persists with morning nausea.
What’s rather striking is the apparent lack of knowledge from many of these doctors, with it appearing that several doctors even continued prescribing these medications and even at higher doses to their patients even though they were experiencing some gastrointestinal-related issues.
Another plaintiff Debbie Kirtz who alleges an H. pylori infection, gastroparesis, and pancreatitis comments that her doctors never warned her of serious side effects in an interview provided by CBS Philadelphia (journalist Stephani Stahl):
Stahl: Did you read the warning label that comes with the drug?
Kirtz: Yeah, I just know that I was going to go through some symptoms, but not halfway die.
Kirtz said the doctor who prescribed Ozempic only talked about the potential for minor side effects.
"The only thing they would say is you might get nauseous, nauseated or constipation," Kirtz said.
Novo Nordisk and Eli Lilly are, of course, defending themselves against these claims suggesting that the drugs are safe and with known risks and benefits provided on the drug label.
Here’s one response provided to Law&Crime from Novo Nordisk:
Novo Nordisk said in a statement to Law&Crime via email on Friday that the lawsuits “are without merit” and the company intends to “vigorously defend against these claims,” though it was pleased with the decision to coordinate all of the litigation before U.S. District Judge Gene E.K. Pratter. Pratter was appointed by former President George W. Bush.
“Patient safety is our top priority at Novo Nordisk and we work closely with the U.S. Food and Drug Administration to continuously monitor the safety profile of our medicines,” a spokesperson for Novo Nordisk said. “GLP-1 medicines have been used to treat type 2 diabetes (T2D) for more than 18 years, and for the treatment of obesity for 8 years. This includes Novo Nordisk GLP-1 products such as semaglutide and liraglutide that have been on the market for more than 13 years. Semaglutide has been extensively examined in robust clinical development programs, large real world evidence studies and has cumulatively over 9.5 million patient years of exposure. The known risks and benefits of semaglutide and liraglutide medicines are described in their FDA-approved product labeling. Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”
But note that gastroparesis, ileus, and other serious gastrointestinal complications are not noted on Ozempic’s label.
For instance, a 2020-dated label for Ozempic notes the following warnings and precautions, which does include pancreatitis but nothing regarding the gallbladder:
However, a 2022-dated label for Ozempic includes various postmarketing experiences which includes issues regarding the gallbladder including acute gallbladder disease:
And it was only last year that ileus was included on the drug label as another postmarketing experience:
FDA updates Ozempic label to include intestinal paralysis as an adverse reaction
On September 22nd the FDA added an additional warning to Ozempic’s label, this time noting ileus, or intestinal paralysis, as a post-marketing adverse reaction, suggesting that these adverse reaction…
All this to say, it’s very disingenuous for Novo Nordisk to claim that these possible adverse events are listed on their drug label when most of these warnings are recent additions due to patients experiencing them. How would any of these plaintiffs and their doctors be aware of these possible side effects if they were never featured on the label until just two years ago at the very least?
Although these adverse events seem relatively rare it’s important to remember that this isn’t about the frequency of these rare events but whether patients are being properly informed about side effects and what to take heed of when taking these medications.
It’s rather concerning that many doctors appear to continue prescribing these drugs, and at increasing doses even when patients are experiencing side effects, almost as if patients are supposed to just forget about the side effects and to persevere until they go away.
Again, it’s informed consent that is at play here.
And it’s even more shocking that this lawsuit is likely to be overshadowed by Oprah Winfrey’s new special praising these drugs as removing stigma and shame:
So while dozens of people bring forward their lawsuits against these multibillion dollar companies Oprah is parading around touting how great these drugs are and why her thoughts on them have changed (seemingly as Weight Watchers buys a telehealth company to start their own GLP-1 program). Pardon me if this all seems a little too coincidental…
Remember that my intent is not to completely dissuade people from taking these medications, but it’s having an understanding of what they are. Again, it’s informed consent that matters, and one has to ask him/herself how much s/he knows about these medications, and quite frankly how much doctors know about these medications as well.
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Just because a medical deity writes on their holy prescription pad does NOT require one to fill or take the medication. There is such a thing as personal ACCOUNTABILITY. Read the damn inserts.
Snowball effect. When people lose respect and trust of pharma, they're more likely to be litigious. Lawyers are salivating.