Woman sues drug makers of Ozempic and Mounjaro over severe gastrointestinal issues

SHORTAGE OF GAME OFFICIALS. MILLIONS OF PEOPLE ARE USING INJECTABLE MEDICATION TO TRY AND LOSE WEIGHT. HERE TO TALK ABOUT THAT IS DOCTOR TODD ELLERIN ACTING CHIEF OF MEDICINE AT SOUTH SHORE HEALTH. GOOD TO SEE YOU, DOCTOR. HEY, DR. T, IT’S GREAT TO SEE YOU SO IF I PUT YOU THE NAMES, HELP ME HERE. BUT THE THREE MOST COMMON BRAND NAMES ARE OZEMPIC, WHERE V AND MAGARO. BUT THEY AREN’T ACTUALLY MEANT FOR WEIGHT LOSS. THEY’RE MEANT TO TREAT DIABETES. SO HOW ARE PEOPLE WHO AREN’T DIABETIC GETTING IT ALL RIGHT, SO LET ME JUST TWEAK THAT A LITTLE BIT. SO OZEMPIC AND MUNJAL ARE DIABETIC MEDICATIONS. OKAY. WE’RE GOVI IS A WEIGHT LOSS MEDICATION NOW, THE DIFFERENCE BETWEEN OZEMPIC AND GOVI IS REALLY JUST THE DOSAGE. OKAY, WE’LL GO TO THESE HIGHER DOSAGE. SO WHAT THEY FOUND IS THESE TYPE OF MEDICAL ACTIONS THAT ARE VERY ACTIVE AND EFFECTIVE AT HELPING DIABETICS. WHAT SCIENTISTS AND CLINICIANS HAVE SEEN IS THERE’S ALSO WEIGHT LOSS. OKAY. AND SO THE PHARMACEUTICAL COMPANIES HAVE TAKEN ADVANTAGE OF THAT. AND ARE NOW LOOKING AT THESE FOR CHRONIC WEIGHT LOSS AND WHAT WAS THE FIRST FDA APPROVED MEDICATION ABOUT TWO YEARS AGO NOW. AND AND MUJURU, WHICH YOU HAD MENTIONED, THAT’S ACTUALLY THE FDA IS TRYING TO FAST TRACK THAT FOR APPROVAL. GOT IT. BUT HOW ARE PEOPLE GETTING IT? YEAH, WELL, REMEMBER, IF YOU’RE USING GOVI, THAT’S BEEN APPROVED FOR PATIENTS WHO ARE OBESE, THAT MEANS A BMI, A BODY MASS INDEX OF 30 OR MORE, OR THOSE WHO ARE OVERWEIGHT, BUT ALSO HAVE ADDITIONAL RISK FACTORS LIKE HIGH BLOOD PRESSURE AND DIABETES. SO YOU CAN GET IT THROUGH INSURANCE. OF COURSE, SOME PEOPLE, SOME CLINICIANS ARE ARE PRESCRIBED IT WHAT WE CALL OFF LABEL. SO IT MAY NOT BE FOR A DIABETIC. AND AND THAT’S WHEN WE HAVE TO REALLY JUST BE CAREFUL BECAUSE WE WANT TO MAKE SURE THAT THESE MEDICATIONS ARE THERE FOR THE DIABETICS AND WE WANT TO MAKE SURE THOSE THE MEDICATIONS ARE THERE FOR THE OBESE PATIENTS. SO IF YOU JUST WANT TO LOSE A FEW POUNDS, THIS IS NOT THE RIGHT MEDICATION BECAUSE THEN THAT HURTS THE EQUITY PIECE. RIGHT. BECAUSE SOME OF THE PEOPLE THAT ARE THE MOST OBESE ARE ALSO THE POOREST, DON’T HAVE ACCESS TO GYMS, DON’T NECESSARILY HAVE ACCESS TO THAT HEALTHY FOOD. SO THESE ARE SUPPOSED TO BE USED IN CONJUNCTION. SO THE MEDICATIONS. DR. T WORK BY SUPPRESSING A PERSON’S APPETITE, RIGHT? MAKING THEM FEEL FULL. IF, YOU KNOW, JUST A BASIC QUESTION, IS THAT A SAFE WAY TO LOSE WEIGHT? YEAH, IT’S A IT’S A FAIR OBSERVATION. I WILL SAY IN GENERAL, I’LL SAY YES. NOW, REMEMBER A FEW THINGS. WEIGHT LOSS OF ABOUT 5 TO 10% OF TOTAL WEIGHT CAN GREATLY REDUCE YOUR RISK OF DIABETES. IF YOU’RE PRE-DIABETIC. IT CAN REDUCE YOUR BLOOD PRESSURE. IT CAN REDUCE YOUR RISK OF CARDIOVASCULAR DISEASE. SO THESE ARE REALLY IMPORTANT. BUT IT’S TRUE THAT, YOU KNOW, YOU WANT TO MAKE SURE THAT YOU’RE GETTING THIS TO THE RIGHT PERSON. AND AND THERE ALSO CAN BE SIDE EFFECTS AS WELL. AND I THINK AND WE’LL TALK ABOUT THAT. WELL, LET’S TALK ABOUT THAT. YEAH. WHAT KIND OF SIDE EFFECTS RIGHT. SO SO NAUSEA AND VOMITING OR GASTROINTESTINAL SIDE EFFECTS ARE COMMON. THERE ARE CONTRAINDICATED ACTIONS TO THESE. IF YOU HAVE A HISTORY OF PANCREATIC TITUS, OR IF YOU HAVE A HISTORY OF THYROID CANCER, A SPECIFIC TYPE OF THYROID CANCER, THEN YOU DON’T WANT TO USE THESE MEDICATIONS. I THINK OVERALL, WHAT I WANT TO EMPHASIZE AT THIS IS ONE AT ADJUNCT TO WEIGHT LOSS. WEIGHT LOSS INCLUDES HEALTHY FOOD IS THE MOST IPORTANT. PHYSICAL ACTIVITY IS IMPORTANT BEHAVIOR MODIFICATION AS WELL. THIS THIS IS USED IN CONJUNCTION. AND REMEMBER ONCE YOU START THESE INJECTIONS AND THESE ARE INJECTIONS, THAT’S ANOTHER, YOU KNOW, SIDE EFFECT. YOU CAN SAY IS INJECTION SITE REACTIONS. BUT ONCE YOU START IT, YOU YOU YOU CAN LOSE UP TO A CERTAIN AMOUNT OF WEIGHT. ONCE YOU’VE ACHIEVED THAT MAXIMAL AMOUNT, THEN YOU PLATEAU. IT DOESN’T MEAN IT DOESN’T IT DOESN’T MEAN IT STOPPED WORKING. IT JUST MEANS YOU’RE NOT GOING TO LOSE ANY MORE WEIGHT. BUT REMEMBER, PEOPLE WHO STOP THESE MEDICATIONS ABOUT YOU GAIN ABOUT TWO THIRDS OF THE WEIGHT. YOU LOST BACK AT ABOUT ONE YEAR. SO IT’S LIKE ANYTHING ELSE, WE HAVE TO KEEP ON IT FOR IT TO CONTINUE TO WORK. ALL RI

In a lawsuit filed on Wednesday, a Louisiana woman is claiming she has suffered severe injuries due to her use of Ozempic and Mounjaro, which were prescribed by her doctor. The two injectable medications, developed to manage diabetes, have gained popularity for weight loss. Attorneys for Jaclyn Bjorklund claim that the 44-year-old woman used Ozempic for more than a year until around July 2023 and then began using Mounjaro. She is suing the makers of both drugs, Novo Nordisk and Eli Lilly, for failing to warn of the risk of severe gastrointestinal events that could be caused by taking the medications."As a result of using Defendants' Ozempic and Mounjaro, Plaintiff was caused to suffer from severe gastrointestinal events, and as a result sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses," the lawsuit alleges.Bjorklund has suffered from "severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating," it adds. The lawsuit claims that the two companies, Novo Nordisk and Eli Lilly, "knew of the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis."Their "failure to disclose information that they possessed regarding the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis, rendered the warnings for this medication inadequate," it continues. Vomiting and abdominal pain are both listed as possible adverse events on prescribing information for Ozempic and Mounjaro, and the lawsuit does not say whether Bjorklund was diagnosed with gastroparesis — stomach paralysis. The lawsuit is seeking compensatory and punitive damages for past and future pain and suffering Bjorklund will have including health care costs and medical monitoring as well as her attorney's fees and court costs. Novo's Ozempic and a similar drug, Wegovy, utilize the same medication, semaglutide. Eli Lilly's Mounjaro uses tirzepatide. These and other drugs in this family, which includes medications like liraglutide, work by mimicking a hormone that's naturally made by the body, GLP-1, that slows the passage of food through the stomach, which helps people feel fuller longer.Separately from the new lawsuit, CNN has reported on warnings from patients and doctors of gastroparesis and other side effects after taking Wegovy and Ozempic for weight loss or diabetes.Stomach paralysis, or the slowing of the stomach from emptying, may lead to nausea and vomiting in some patients. It can have many causes, including diabetes, which is a reason many people take drugs. Women are known to be at higher risk for the condition. Doctors told CNN that more cases are coming to light as the popularity of the drugs has soared. In a statement before the lawsuit, the U.S. Food and Drug Administration told CNN it had "received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report." Video below: Everything you need to know about new breakthrough weight loss drugsOzempic's prescribing information says the most common adverse events related to the drug are nausea, vomiting, diarrhea, abdominal pain and constipation. Under a section on drug interactions, it says that Ozempic delays gastric emptying, which may impact absorption of oral medications. Mounjaro's prescribing information also says nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain are the most common adverse events, and that Mounjaro delays gastric emptying, which may impact medication absorption. In a statement to CNN responding to stomach paralysis concerns prior to the lawsuit, Novo Nordisk, the maker of Ozempic and Wegovy, said, "Gastrointestinal (GI) events are well-known side effects of the GLP-1 class. For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration. GLP-1's are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects."Responding to the new lawsuit, a spokesperson for Novo Nordisk told The Hill, "Patient safety is of utmost importance to Novo Nordisk. "We are continuously monitoring the safety profile of our products and collaborate closely with authorities to ensure patient safety, including adequate information on gastrointestinal side effects in the label."In a statement obtained by The Hill, a spokesperson for Eli Lilly, maker of Mounjaro, said that patient safety is the company's "top priority," and that they "actively engage in monitoring, evaluating and reporting safety information for all our medicines," the news outlet reported.CNN has reached out to both Novo Nordisk and Eli Lilly for comment on the lawsuit.

Attorneys for Jaclyn Bjorklund claim that the 44-year-old woman used Ozempic for more than a year until around July 2023 and then began using Mounjaro. She is suing the makers of both drugs, Novo Nordisk and Eli Lilly, for failing to warn of the risk of severe gastrointestinal events that could be caused by taking the medications.

"As a result of using Defendants' Ozempic and Mounjaro, Plaintiff was caused to suffer from severe gastrointestinal events, and as a result sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses," the lawsuit alleges.

Bjorklund has suffered from "severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating," it adds.

The lawsuit claims that the two companies, Novo Nordisk and Eli Lilly, "knew of the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis."

Their "failure to disclose information that they possessed regarding the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis, rendered the warnings for this medication inadequate," it continues.

Vomiting and abdominal pain are both listed as possible adverse events on prescribing information for Ozempic and Mounjaro, and the lawsuit does not say whether Bjorklund was diagnosed with gastroparesis — stomach paralysis.

The lawsuit is seeking compensatory and punitive damages for past and future pain and suffering Bjorklund will have including health care costs and medical monitoring as well as her attorney's fees and court costs.

Novo's Ozempic and a similar drug, Wegovy, utilize the same medication, semaglutide. Eli Lilly's Mounjaro uses tirzepatide. These and other drugs in this family, which includes medications like liraglutide, work by mimicking a hormone that's naturally made by the body, GLP-1, that slows the passage of food through the stomach, which helps people feel fuller longer.

Separately from the new lawsuit, CNN has reported on warnings from patients and doctors of gastroparesis and other side effects after taking Wegovy and Ozempic for weight loss or diabetes.

Stomach paralysis, or the slowing of the stomach from emptying, may lead to nausea and vomiting in some patients. It can have many causes, including diabetes, which is a reason many people take drugs. Women are known to be at higher risk for the condition.

Doctors told CNN that more cases are coming to light as the popularity of the drugs has soared. In a statement before the lawsuit, the U.S. Food and Drug Administration told CNN it had "received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report."

Video below: Everything you need to know about new breakthrough weight loss drugs

Ozempic's prescribing information says the most common adverse events related to the drug are nausea, vomiting, diarrhea, abdominal pain and constipation. Under a section on drug interactions, it says that Ozempic delays gastric emptying, which may impact absorption of oral medications.

Mounjaro's prescribing information also says nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain are the most common adverse events, and that Mounjaro delays gastric emptying, which may impact medication absorption.

In a statement to CNN responding to stomach paralysis concerns prior to the lawsuit, Novo Nordisk, the maker of Ozempic and Wegovy, said, "Gastrointestinal (GI) events are well-known side effects of the GLP-1 class. For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration. GLP-1's are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects."

Responding to the new lawsuit, a spokesperson for Novo Nordisk told The Hill, "Patient safety is of utmost importance to Novo Nordisk. "We are continuously monitoring the safety profile of our products and collaborate closely with authorities to ensure patient safety, including adequate information on gastrointestinal side effects in the label."

In a statement obtained by The Hill, a spokesperson for Eli Lilly, maker of Mounjaro, said that patient safety is the company's "top priority," and that they "actively engage in monitoring, evaluating and reporting safety information for all our medicines," the news outlet reported.

CNN has reached out to both Novo Nordisk and Eli Lilly for comment on the lawsuit.

Woman sues drug makers of Ozempic and Mounjaro over severe gastrointestinal issues

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