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Tuesday, 12 November, 2024
HomeMedico-LegalNovo, Lilly sued by patients for gastroparesis

Novo, Lilly sued by patients for gastroparesis

Swedish drugmaker Novo Nordisk has denied that its diabetic drug Ozempic is responsible for causing stomach paralysis in patients, and has vowed to “vigorously defend” itself against any such claims – by thousands of Americans – which it says are “without merit”.

The plaintiffs, from across the US, are claiming in a federal lawsuit that Ozempic, Mounjaro and other popular drugs prescribed for diabetes and obesity harmed their health, and that the pharmaceutical companies that manufactured them failed to warn patients of their risks.

USA Today reports that the lawsuit against Novo, as well as Eli Lilly, was filed this year. It’s in the discovery process and may go to trial in 2025.

Central to the lawsuit is the claim that Ozempic caused plaintiffs’ gastroparesis.

“We represent more than 3 000 people from all walks of life,” said Andrew Van Arsdale, founding attorney of the AVA Law Group, the firm representing them.

Novo spokesperson Jamie Bennett said the company would defend itself against the claims.

Devastating

One of the claimants is Ohio’s Dana Filmore (55), who was initially terrified of taking Ozempic, as she had a chronic fear of needles.

Yet the anti-diabetic pills she was taking weren’t enough to bring her blood sugar down to a healthy level. Her doctor said Ozempic, approved for Type 2 diabetes, could help.

So Filmore bit the bullet – but now, three years later, her doctor has diagnosed her with gastroparesis, or stomach paralysis, a potential side effect of the drug. Six months after stopping the injections, Filmore still can’t keep food down.

Normally, the stomach contracts to propel food through the digestive tract. With gastroparesis, the stomach muscles are paralysed, so food lingers in the stomach for longer than it should, which results in vomiting or diarrhoea.

“You never know what will set it off,” said Filmore, who has to run to the bathroom within minutes of starting a meal.

‘Scared to eat’

Filmore said her nausea and lack of bowel control, which began in the last six months that she was on Ozempic, forced her to burn through her vacation time to try to recover.

Though she has since been able to return to her job, where she manages over a dozen technicians at a mechanical company, her 35-minute commute poses a daily struggle.

Filmore’s stomach has her scared to eat, so her diet now mostly consists of broth, soup, jelly and protein shakes. She doesn’t feel she’s getting the nutrients she needs, but not having a full meal is the only way she can avoid running to the bathroom.

Denials

Novo Nordisk representatives are adamant that Ozempic is not responsible for causing gastroparesis in Filmore and other plaintiffs.

The known risks and benefits of semaglutide and liraglutide − the active ingredients in weight loss drugs – “are described in their FDA-approved product labelling”, Bennett said.

The FDA’s most up-to-date warning label for Ozempic notes that clinical trials for the drug caused some participants to experience gastrointestinal reactions, like nausea and diarrhoea. However, it does not list gastroparesis, a condition that is often permanent and incurable, as a potential side effect.

“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,” said Bennett.

Eli Lilly, also named in the lawsuit for failing to warn patients about the risks of Mounjaro, specifically developed to manage Type 2 diabetes by slowing digestion and reducing appetite, said it would also defend itself against the claims.

“Patient safety is Lilly’s top priority,” said company spokesperson Jared Shapiro. “Our FDA-approved label clearly warns that Mounjaro may be associated with gastrointestinal adverse reactions, sometimes severe.”

Unlike Ozempic, Mounjaro’s FDA warning label mentions that the drug has not been studied in those with severe gastrointestinal disease and is not recommended for those patients.

Still, according to Shapiro, the company is “vigorously defending” against the claim that the drug caused gastroparesis.

In a 2023 study of drugs including Ozempic and Mounjaro, Canadian researchers found that they were associated with a higher risk of serious conditions like gastroparesis and pancreatitis.

Dr Mohit Sodhi, first author for the study, published by the Journal of the American Medical Association, said the medication may have caused gastroparesis in the patients represented in the lawsuit.

“One of the ways Ozempic helps with weight loss is that it delays gastric emptying and decreases intestinal motility,” he said. “It is possible that in some patients this side effect is so severe that it causes gastroparesis.”

While further research is needed to validate his findings, Sodhi said his study found that the rate of gastroparesis in patients using drugs like Ozempic was around 1%. Still, with millions of Americans on these medications, 1% could translate to hundreds of thousands of patients being affected by gastroparesis, he said.

Dr Sun Kim, a board-certified endocrinologist at Stanford Health Care who treats patients with Type 2 diabetes and obesity, said she always mentions the risk of developing gastroparesis to her patients before prescribing a drug like Ozempic.

Determining the cause of gastroparesis is difficult, she added, because it’s also a side effect of Type 2 diabetes, especially for patients who’ve had diabetes for a while.

In her practice, a patient’s side effects usually cease after they stop the drug, which hasn’t been the case with patients like Dana Filmore.

“The lingering question is, could it cause more permanent effects?” Kim said. “There’s no definitive answer on this.”

Side effects reported to FDA: 20 000 cases

More than 21 638 cases of side effects of Ozempic have been reported to the FDA since 2018, according to the agency’s Adverse Event Reporting System.

That’s higher than usual for a treatment that’s only recently reached the market, said Sodhi, but given the medication’s status as a household name, he thinks people are more likely to report side effects than they are for other drugs.

Gastrointestinal conditions like gastroparesis make up 43% of reports – though symptoms like nausea were more commonly reported than severe gastrointestinal illness like gastroparesis. This isn't surprising, adds Kim, who says clinical trials of Ozempic showed that the top side effect was gastrointestinal.

FDA spokesperson Chanapa Tantibanchachai said the FDA is aware of the reports but awaiting evidence that shows whether the drug caused gastroparesis.

It’s unclear whether drugs like Ozempic contributed to gastroparesis when used in patients with Type 2 diabetes, she said.

“Gastroparesis can be a complication of diabetes that is related to long-standing or poorly controlled disease.”

 

JAMA Network article – Risk of Gastrointestinal Adverse Events Associated with Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss (Open access)

 

USA Today article – She took Ozempic, now she can't eat without vomiting. Lawsuit claims the drug made her ill (Open access)

 

See more from MedicalBrief archives:

 

Two diabetes drug firms sued over ‘stomach paralysis’ claim

 

US study finds serious side effects from weight-loss drugs

 

Patients felled by weight-loss drugs’ side effects

 

Women sues after weight-loss drugs lead to bowel surgery

 

 

 

 

 

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