April 20, 2024

A possible threat of ‘pulmonary aspiration’ for individuals taking Ozempic or associated medication is the newest potential security threat being flagged

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Abdomen “paralysis” and ideas of self-harm. Severe issues have been raised about immediately’s wildly standard weight-loss medication.

Now, American and Canadian anesthesiologists are flagging one other “sign of concern,” a probably life-threatening complication for individuals present process surgical procedure — particularly, the danger of them regurgitating abdomen contents whereas sedated and inhaling meals into their lungs.

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The complication — pulmonary aspiration — can result in pneumonia, respiratory misery and, within the worst-case state of affairs, loss of life.

The priority is predicated on a smattering of case stories and small observational research involving sufferers taking Ozempic, or associated medication, who nonetheless had important quantities of meals of their stomachs whereas underneath anesthesia, even after fasting for as much as 18 hours.

Sometimes given through as soon as weekly injections of a pre-filled pen, the medication partly work by delaying gastric emptying. Meals lingers within the abdomen longer earlier than it’s ferried to the intestines, making individuals really feel fuller longer.

Dr. Ion Hobai first reported a case final September involving a 42-year-old man present process a routine gastric endoscopic process, the place a versatile tube with a digital camera is handed down the throat and into the abdomen.

Docs have been alarmed to find that, though he’d had nothing to eat for 18 hours, he nonetheless had a “huge quantity” of undigested meals in his abdomen, mentioned Hobai, an anesthesiologist at Massachusetts Basic Hospital.

This was a probably critical, probably deadly complication

It was the affected person’s fifth endoscopic process over about two years. All had gone easily with none downside; his abdomen was empty. The distinction this time was that he’d began taking Ozempic for weight reduction two months earlier.

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It rapidly turned an emergency: “We needed to cease the process, put a respiratory tube in and one other instrument into his lungs to scrub the lungs from the meals that he inhaled and aspirated,” Hobai mentioned. The person spent the night time in intensive care. He was in a position to go house the next day.

“He was in good situation and stayed in good situation; however this was a probably critical, probably deadly complication,” Hobai mentioned.

“This might all be not an actual situation, however once you’re speaking about perioperative aspiration that may trigger loss of life, I feel we have to act out of an abundance of warning,” mentioned Dr. Philip Jones, a professor of anesthesiology on the Mayo Clinic and deputy editor-in-chief of the Canadian Journal of Anesthesia. “Pressing and prime quality analysis” must be accomplished to determine what the issue is, if any, he mentioned.

Within the meantime, in a just-published editorial, he and his co-authors advocate that folks taking the medication for weight reduction take into account stopping them for 3 weeks earlier than present process sedation. That’s how lengthy they anticipate it takes for the physique to clear 90 per cent of the medication.

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As their recognition grows, so, too, are stories of doable opposed reactions. Latest headline-grabbing tales have included a doable elevated threat of “gastroparesis,” a situation that impacts the nerves and muscle tissue of the abdomen, and suicidal ideation.

There isn’t any proof of cause-and-effect relationships, specialists mentioned. If there’s a “reliable” hyperlink between the burden loss medication and suicidal ideation — and Canada’s drug regulator is assessing whether or not there’s — “it’s undoubtedly uncommon,” Dr. Joe Schwarcz, director of McGill College’s Workplace for Science and Society lately mentioned on his standard YouTube channel. It “wouldn’t have been picked up within the research that led to approval,” he added.

Whereas the medication have led to important weight reduction for individuals who have lengthy struggled with weight problems, Schwarcz is anxious that the “vigorous promoting on U.S. tv that reveals Ozempic customers fortunately doing yoga or taking part in pickle ball” can obscure the truth that they’re “critical drugs with a wide range of doable unintended effects.”

“It’s not a miracle drug as so many social media websites declare,” Schwarcz mentioned in an interview with Nationwide Publish. “There are not any miracles in science.”

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Novo Nordisk, producers of Ozempic, its sibling drug Wegovy, and a associated product, Saxenda, mentioned it “stays assured within the profit threat profile” of its medication.

“Affected person security is of utmost significance to Novo Nordisk, and we take all stories about opposed occasions from use of our medicines very severely,” Kate Hanna, director of communications for Novo Nordisk Canada mentioned in a press release to Nationwide Publish.

“Our group is repeatedly monitoring the security profile of our merchandise and collaborating carefully with well being authorities to make sure affected person security data, together with satisfactory data on unintended effects, are included within the product monograph.”

The medication belong to a category formally identified by the considerably unwieldy identify, glucagon-like peptide-1 (GLP-1) receptor agonists. They mimic a pure hormone that delays the transit of meals by the abdomen.

Some of the used — and its use has exploded — is semaglutide, the lively ingredient in Ozempic and Wegovy.

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Semaglutide has been used for greater than 15 years to deal with diabetes. At increased doses the drug additionally decreases urge for food by engaged on the mind’s starvation centres and slowing “gastric emptying.”

The latter impact, Jones and colleagues wrote within the Canadian Journal of Anesthesia, suits with frequent complaints of nausea, diarrhea, vomiting and different gastro-related points.

However that delayed gastric emptying may additionally be sufficient to pose a critical menace to surgical procedure sufferers “by growing the danger of pulmonary aspiration of regurgitated gastric contents,” they mentioned.

“The explanation why individuals come to the working room fasted is for an necessary cause: we would like the abdomen to be empty to scale back the prospect of aspiration,” mentioned Jones, who lately joined the Mayo Clinic after 20 years at Western College.

When persons are given average or deep sedation, they lose their capacity to cough and shield their very own airway.

If the abdomen isn’t empty, individuals can find yourself regurgitating meals from the abdomen after which inhaling it into the lungs.

Usually, aspiration happens in a single in 3,000 to at least one in 5,000 procedures.

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It’s not a miracle drug as so many social media websites declare

Jones mentioned the medication are of “potential monumental public well being significance” given immediately’s staggering charges of weight problems and sort 2 diabetes.

However whereas the case stories and chatter in “docs’ lounges internationally” could also be nothing however “spurious associations” — which means no cause-and-effect relationship — it’s prudent to take a precautionary method till extra rigorous analysis is completed, he and his co-authors wrote.

Individuals taking the medication for diabetes must also take into account consulting with an endocrinologist in regards to the dangers and advantages of holding off for at the very least three weeks previous to surgical procedure, they mentioned.

Well being Canada, in the meantime, is assessing whether or not any potential affiliation exists between the GLP-1 class and an elevated threat of ideas of suicide or self-harm.

The European Medicines Company, in addition to drug regulators within the U.S. and U.Ok. have launched related probes. Final month, the European company mentioned it’s analyzing about 150 stories of doable instances of self-injury and suicidal ideas in individuals taking GLP-1 receptor antagonists, together with Ozempic, Wegovy and Saxenda.

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Well being Canada has obtained six stories of suicidal ideas with Ozempic. The stories haven’t been medically assessed or verified, “and the reported opposed occasions should not essentially brought about by means of these merchandise,” the division mentioned in a press release to the Nationwide Publish.

Hana mentioned security knowledge from giant scientific trials and post-marketing surveillance “haven’t demonstrated a causal affiliation” between the medication and suicidal and self-harming ideas.

Some stories have additionally surfaced about extreme gastroparesis — paralysis of the abdomen. The abdomen muscle tissue don’t transfer the conventional methods they need to. Contractions get weaker and slower than wanted to digest meals and propel it by the digestive tract.

In a lately launched lawsuit within the U.S., a Louisiana girl who mentioned she took Ozempic for a 12 months earlier than switching to Mounjaro, a more recent, associated drug in July, claims she suffered such extreme vomiting from gastroparesis that her enamel fell out.

“Gastrointestinal occasions” are well-known unintended effects of the GLP-1 class, Hana mentioned. Diabetes can also be a identified threat issue for gastroparesis, and different components akin to weight problems, gender (being feminine) and viral infections may additionally enhance the danger, she mentioned.

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Not like Wegovy, Ozempic hasn’t been formally authorized by Well being Canada for weight reduction, although docs can prescribe it “off label” for weight problems.

Greater than 3.5 million prescriptions value almost $1.2 billion have been distributed for Ozempic in Canada in 2022, in keeping with knowledge offered to Nationwide Publish from IQVIA CompuScript.

Novo Nordisk introduced Friday it’s anticipating a brief scarcity of its one milligram Ozempic injection pen for Canada, from late August to early October, as a consequence of world provide constraints and elevated demand.

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