Latest / Morning Medical with Dr. Chow / FDA Warning on Compounded Semaglutide, Disappearance of B/Yamagata, and Mental Health in Sports

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FDA Warning on Compounded Semaglutide, Disappearance of B/Yamagata, and Mental Health in Sports · Morning Medical with Dr. Chow

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Good morning and welcome to another episode of Morning Medical with Dr.
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Chow.
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I am your host, Dr.
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Chi-Ming Chow, and today we have some crucial updates to share with you.
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Let's dive right in.
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Today, we are discussing a critical warning from the Food and Drug Administration regarding
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compounded semaglutide.
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According to a recent alert from the agency, overdoses, some severe enough to require
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hospitalization, have been reported due to confusion among both patients and healthcare
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providers around compounded semaglutide.
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The adverse events reported to the Food and Drug Administration have ranged from
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gastrointestinal issues such as nausea, vomiting, and abdominal pain—common side
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effects with GLP-1 receptor agonists—to more severe complications like fainting, headache,
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migraine, dehydration, acute pancreatitis, and gallstones.
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While the Food and Drug Administration-approved injectable semaglutide, known by the brand
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names Ozempic and Wegovy, is dosed in milligrams and comes in prefilled pens,
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compounded semaglutide can come in varying concentrations and uses multiple-dose vials.
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This variability has led to problems in both patients’ self-administration and healthcare
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providers’ dose calculations.
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The Food and Drug Administration explained that many patients who received vials of compounded
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semaglutide lacked experience with self-injections.
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This unfamiliarity with withdrawing medication from a vial into a syringe, coupled with
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confusion between different units of measurement—such as milliliters, milligrams,
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and 'units'—may have contributed to dosing errors.
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In some alarming cases, patients have administered five to twenty times more than the
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intended dose of semaglutide after mistakenly drawing up too much from a multiple-dose vial.
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For instance, patients were sometimes instructed to use a U-100 insulin syringe to
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draw up small doses, like a 5-unit dose, but mistakenly administered 50 units instead.
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In one reported incident, a patient had difficulty obtaining clear dosing instructions
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from a telemedicine provider who prescribed the compounded semaglutide.
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This led the patient to search online for medical advice, ultimately resulting in them
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taking five times the intended dose.
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Other reports highlighted that healthcare providers were also responsible for dose
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miscalculations when converting from milligrams to units or milliliters.
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One healthcare provider intended to dose 0.25 milligrams (5 units) but mistakenly prescribed
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25 units instead, causing severe vomiting for the patient.
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In another case, a provider prescribed 20 units instead of 2 units to three patients, all of
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whom later experienced nausea and vomiting.
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Even healthcare providers who self-prescribed the drug have made errors.
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One provider tried to recalculate their dose in units and ended up administering a dose ten
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times higher than intended.
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The Food and Drug Administration advises healthcare providers to be vigilant when
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prescribing compounded semaglutide.
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They should contact the compounder for assistance with dose calculations if there is
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any uncertainty.
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Providers and compounders should also ensure that patients receive the appropriate syringe
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size for the intended dose and educate them on how to measure the dose correctly.
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Compounded semaglutide has grown in popularity over the past few years due to increased demand
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for GLP-1 receptor agonists, which led to supply and access issues.
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However, the Food and Drug Administration emphasizes that compounded drugs should only be
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used for patients whose medical needs cannot be met by an available FDA-approved drug.
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Unlike Novo Nordisk's branded semaglutide, compounded versions do not undergo the same
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Food and Drug Administration premarket review for safety, quality, or effectiveness.
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In fact, a review found high levels of known impurities and unknown impurities in some
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compounded semaglutide products.
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One product tested contained more than 24 percent impurities, including unknown ones.
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Once-weekly injectable semaglutide was first approved for type 2 diabetes under the brand
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name Ozempic in 2017.
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In 2021, it received approval for chronic weight management in adults with obesity or who
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are overweight with at least one weight-related condition under the brand name Wegovy.
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Most recently, it gained an indication to reduce the risk of cardiovascular death, heart
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attack, and stroke in adults with cardiovascular disease and either obesity or
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overweight.
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The Food and Drug Administration acknowledges the substantial interest in compounded
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semaglutide products marketed for weight loss.
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The agency is urging compounders, healthcare providers, and patients to report any adverse
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events and errors with compounded semaglutide to its MedWatch Adverse Event Reporting
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program.
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A new study suggests that there's a link between semaglutide use and lower rates of
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treatment for tobacco use disorder among people with type 2 diabetes.
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A growing set of evidence suggests that using semaglutide could lead to decreased substance
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use, and a large new study shows a promising link between the medication and tobacco use.
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But experts emphasize that much more research is needed before using the medications
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off-label for smoking cessation.
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In a study published Monday in the journal Annals of Internal Medicine, researchers
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tracked the medical records of more than two hundred thousand people who started medications
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to treat type 2 diabetes, including nearly six thousand people using semaglutide medications
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such as Ozempic.
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Over the course of a year, people who started using semaglutide were significantly less
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likely to have medical encounters for tobacco use disorders, prescriptions for medications
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for smoking cessation, or counseling for smoking cessation than those who started other
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diabetes medications such as insulin and metformin.
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The study authors note that the reasons individuals might be less likely to seek
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medical treatment for tobacco use disorder vary widely; it could suggest that their tobacco use
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decreased or that they have become less willing to seek help to quit smoking, for example.
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There might be a mix of medication-driven and patient-driven change, said Dr.
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Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health in
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Chicago, who was not involved in the new research.
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"If I have a patient with type 2 diabetes who is on one of these agents and they do have a
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history of smoking, oftentimes, our visits involve a conversation about tobacco
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cessation," she said.
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"These folks might start paying special attention to their long-term health and
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changing some habits because they are being treated for diabetes."
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Also, the new study did not measure the severity of tobacco use, such as the number of
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cigarettes consumed per day, cravings, or withdrawal.
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Understanding how semaglutide affects these factors is "crucial" to determining whether the
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medications could be used for smoking cessation, said Dr.
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Nora Volkow, director of the National Institute on Drug Abuse and a co-author of the new
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report.
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Also, more work would be needed to understand appropriate dosage and adverse effects before
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using the blockbuster drugs in a new way, she said.
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But other early research suggests that semaglutide and other GLP-1 medications could
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interact with the brain’s reward system in a way that helps modulate cravings, whether for
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food, nicotine, alcohol, or other drugs.
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"The main driver of why many of us overeat relates to those reinforcing positive responses
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that we get from eating certain foods.
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And it’s the same circuit for foods as for drugs," Volkow said.
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Although key questions remain, Volkow said she is struck by how consistent the findings have
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been when it comes to the relationship between semaglutide use and decreased substance use –
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across different substances and among different patient groups.
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The new study found similar links among those with and without obesity.
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"A signal like this one cannot be ignored, particularly because of how consequential it
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could be if, in fact, we can have now a new medication for treating smoking cessation," she
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said.
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"That could have a tremendous impact on health."
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Smoking rates in the United States have decreased over time, but cigarette smoking
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remains the leading cause of preventable disease and death, according to the United
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States Centers for Disease Control and Prevention.
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A recent study from the American Cancer Society found that smoking contributes to nearly one in
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five new cancer cases and nearly a third of cancer deaths each year.
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But fewer than one in ten adult cigarette smokers succeed in quitting each year,
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according to the new study, and options for smoking cessation treatment have not changed
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much in decades.
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A strain of seasonal influenza has completely vanished globally since March 2020, and due to
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its disappearance, health officials in Canada are changing up the annual flu vaccine.
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The B/Yamagata influenza strain, once a dominant force among influenza B viruses, may
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have vanished entirely due to the stringent measures imposed during the COVID-19 pandemic,
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according to the National Advisory Committee on Immunization (NACI).
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No cases have been confirmed across the globe since March 2020.
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Due to the strain’s disappearance, NACI announced on July 26 that expert groups have
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endorsed removing the B/Yamagata component from influenza vaccine formulations.
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As a result, Canada’s flu vaccine will shift from a quadrivalent to a trivalent formula.
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"As of March 2020, following the onset of the COVID-19 pandemic and implementation of
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measures to reduce the transmission of SARS-CoV-2, there have been no confirmed
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detections of naturally circulating B/Yamagata lineage viruses worldwide, including in
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Canada," NACI said in the statement.
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"Based on current epidemiological data, there is global expert consensus that B/Yamagata
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virus strains should be removed from influenza vaccine formulations and that manufacturing
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should transition to trivalent vaccines exclusively," it added.
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Before the strains disappeared, there were four strains of seasonal influenza circulating: two
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from influenza A (H1N1 and H3N2) and two from influenza B (B/Victoria and B/Yamagata).
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Since the 2014 to 2015 flu season, Canada has used quadrivalent influenza vaccines containing
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strains from both influenza B lineages (B/Victoria and B/Yamagata) to offer protection
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against circulating influenza B viruses.
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Although influenza A is usually the dominant strain, both influenza A and B contribute to
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seasonal epidemics.
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Despite its lower overall prevalence, influenza B can still pose a significant burden in
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Canada, accounting for up to 44 percent of reported laboratory detections in some seasons,
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according to NACI.
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"In November, December and into January, we mostly see influenza A.
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And then in the latter part of the season, January, February and tailing off through
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March, we’ll see a little bit more influenza B," explained infectious diseases specialist
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Dr.
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Isaac Bogoch.
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"If you look at the absolute number of cases, we usually have way more influenza A compared
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to influenza B, but B starts to show up a little bit later on in the season."
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He said that while the diagnosis, prevention, and treatment of influenza A and B are the
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same, what differs is their epidemiology.
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This difference in epidemiology might explain why B/Yamagata disappeared while other strains
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persisted.
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The B/Yamagata strain was first discovered in Japan in the late 1980s.
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It began spreading globally and became a predominant influenza strain in North America
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by the early 2000s.
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By the 2014 to 2015 flu season, Canada had added the B/Yamagata strain to its seasonal flu
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vaccine, making it a quadrivalent formula to protect against more influenza types.
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In Canada and globally, between 2012 and 2017, B/Yamagata viruses caused a larger proportion
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of influenza B infections than B/Victoria, NACI said.
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However, two years before the COVID-19 pandemic, the B/Yamagata lineage started
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becoming dominant.
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Then, in March 2020, it seemingly vanished.
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"During the darkest days of COVID, we stopped detecting one of the two influenza B strains
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and that was B/Yamagata," Bogoch said.
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"Was it hiding out somewhere or was it just circulating in lower levels?
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Was it going to somehow emerge later on?
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Those are questions that were asked at that time.
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But, it did not seem to come back."
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Although it has disappeared, Bogoch emphasized that this does not mean the strain is
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eradicated, as eliminating any virus is extremely challenging.
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But there are theories about what happened to it.
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The first theory relates to the public health measures implemented at the start of the
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pandemic.
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A 2022 study published in Nature argued that since April 2020, many countries have seen
14:08
historically low seasonal influenza virus circulation, attributable to quarantines,
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social distancing, school and workplace closures, mask-wearing, surface disinfection,
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and enhanced hand hygiene.
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Bogoch suggested that another factor contributing to the B/Yamagata strain’s
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disappearance could be the "massive drop in human mobility" during the pandemic.
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"If you look at international travel, passenger volumes and human mobility patterns during that
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time, they were a tiny fraction of what they are normally," he explained.
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"And when you look at how seasonal influenza is transmitted, it goes from the southern
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hemisphere and then it works up its way into the northern hemisphere during our winter
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months, and then back to the southern hemisphere during their winter months and
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ping-pongs back and forth."
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He believes that the near standstill in travel during the pandemic, along with tighter border
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restrictions, may have contributed to the decline of the strain.
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Another reason could be "viral interference," he said, meaning the COVID-19 strain may have
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helped suppress a weaker strain of influenza.
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However, he stressed that these are all theories, and a combination of these factors
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may have contributed to the disappearance of the B/Yamagata strain.
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These are just the early stages of transitioning from a quadrivalent to a
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trivalent seasonal influenza vaccine, so the new formula will not be available for the 2024
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to 2025 flu season, according to NACI.
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"For the 2024-2025 influenza season in Canada, vaccine availability is anticipated to remain
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unchanged.
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Quadrivalent formulations will continue to be supplied for public programs.
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No trivalent formulations will be available for standard dose or high dose inactivated
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influenza vaccines," it stated.
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NACI anticipates a gradual transition to trivalent influenza vaccines, acknowledging
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significant logistical challenges and potential regulatory complexities.
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More details about trivalent influenza vaccines will be included in the 2025 to 2026 Influenza
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Seasonal Statement.
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Both quadrivalent and trivalent influenza vaccine formulations are clinically safe and
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effective, according to NACI.
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While the updated vaccine may not be available in Canada this upcoming flu season, the United
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States has already adopted the trivalent formulation for the 2024 to 2025 season.
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The Centers for Disease Control and Prevention (CDC) has announced that flu vaccines will be
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trivalent in the United States for the 2024 to 2025 season.
16:57
"Because influenza B/Yamagata lineage viruses have not been detected after March 2020, the
17:03
World Health Organization (WHO) and FDA’s Vaccines and Related Biological Products
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Advisory Committee (VRBPAC) recommended that the influenza B/Yamagata lineage vaccine virus
17:16
component be excluded from flu vaccines as soon as possible," the CDC website states.
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Since there is no evidence that B/Yamagata is completely eradicated, NACI said it will
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continue to monitor each flu season.
17:30
"Continued epidemiological and virological monitoring of influenza virus, investigation of
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any reports of B/Yamagata detection, and continued assessment of programmatic factors
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remains important, as does clear and transparent communication of updated
17:45
recommendations," it said.
17:48
More than ten thousand elite athletes from around the globe are competing in the 2024
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Paris Olympics, where they face incredible pressures to perform in front of an audience of
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billions.
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For these Olympians, years of grueling preparation and training precede an event that
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leaves no room for error – mere seconds can mean the difference between a medal on the
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winner’s podium or being dropped from competition, retired Olympic speed skater Apolo
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Ohno told the PBS News Hour’s Amna Nawaz.
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And even for those who win gold over and over again, there’s always a day when it’s time to
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say goodbye to their sport at the highest level – a challenge that can be as hard as any race,
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match or routine.
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When Ohno was competing nearly fifteen years ago, the conversation about mental health among
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athletes was very different from the one today.
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“To be completely frank, we didn’t know what that even meant,” he said.
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“The words ‘mental health’ really was mental performance.
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That’s where we focused a lot of our time.”
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Athletes are increasingly weighing their own mental health against the demands of sport and
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pressure to perform, said Jessica Bartley, senior director for psychological services for
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the United States Olympic and Paralympic Committee.
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Postponing the 2020 Tokyo Olympics for a year during the COVID-19 pandemic was “one of the
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most notable times” in terms of athletes needing mental health services, Bartley said.
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That delay unleashed anxiety in many athletes, particularly more experienced competitors,
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because it allowed a new cohort of younger athletes to become eligible to compete against
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them, she noted.
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When the Tokyo Games returned in 2021, Olympic gymnast Simone Biles helped jumpstart a global
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conversation about the importance of mental health awareness as she withdrew from team
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competition.
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“We have to protect our mind and our body, rather than just go out there and do what the
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world wants us to do,” Biles told reporters then.
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When she participates at the Games this summer she does so on her terms and with a new honor –
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as the most decorated gymnast ever.
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Olympians face daunting expectations, Bartley said.
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To reach the Games, many athletes started training for their sport almost as soon as they
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learned how to walk, and have dedicated much of their lives to just one thing.
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Often, Bartley said, athletes have trained with the mentality that “you can’t take your eye off
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the ball or you won’t perform your best.” That can include not paying attention to your own
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mental health nor balancing the demands of your sport with the rest of your life.
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A 2019 meta-analysis of British Journal of Sports Medicine studies found at least a fifth
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of current elite athletes struggled with alcohol and as many as a quarter of former
20:46
athletes grappled with anxiety and depression.
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In response to Biles’ call for the need to prioritize the mental health of athletes, the
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International Olympic Committee in 2023 issued an action plan that highlighted how elite
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athletes are “at increased risk of mental health problems, such as depression, anxiety
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and eating disorders.”
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“While the global mental health burden is significant, we must recognize that mental
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health symptoms are treatable, and in many instances, preventable,” said professor Uğur
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Erdener, chair of the committee’s medical and scientific commission, in a statement when the
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plan was released.
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“By inspiring, encouraging and assisting stakeholders across the Olympic movement, we
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can help build a healthier world in and through sport.”
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The committee’s plan to address mental health challenges and boost well-being focuses on
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improving culture and leadership as well as using data and research, among other measures.
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When Bartley’s staff checks in with athletes from Team USA each year, she said they
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routinely ask about mental health as well physical health, including questions about
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sleep, vaccination status and nutrition, as well as disordered eating, trauma, substance
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use, and anxiety and depression.
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“We’ve really shifted to normalize us asking questions about mental health, checking in.
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We check before Olympic and Paralympic Games, and we’ll check in after,” Bartley said.
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“We’ll do a touchpoint with each of those athletes.”
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Ohno has been speaking out in recent years to raise awareness about mental health needs and
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resources, including with his book, “Hard Pivot,” and in the 2020 HBO documentary “The
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Weight of Gold.” The former speed skater stood up on the Olympic podium eight times, more than
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any other American winter athlete in history.
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But when he reflects upon the career he left behind at age twenty-seven, those moments of
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victory are fleeting.
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Instead, his most powerful memories happened without any spectators, “when it was me against
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myself, digging, striving, trying to find that extra 1 percent.”
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“While we might not always be able to control these outcomes, in that process is where the
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true prize can actually be,” he said.
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When late-career athletes reach out to Bartley and her staff for support, they usually mull
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the same questions.
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They wonder if they can commit to four more years until the next Olympic games convene.
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Many have postponed attending college or graduate school.
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Some have waited to have a family so they could more fully commit to training for their next
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chance to compete, or they are watching their own parents age and contemplating how to step
23:34
up for their caregivers.
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“‘Am I ready to give it up?’” Bartley said athletes often ask her.
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Change is inevitable.
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For Olympians, pivoting after sport comes relatively early in life, clinical and
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cognitive behavioral psychologist Jeff Brown of Harvard Medical School said.
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It may be out of their control, like when an accident completely alters their trajectory in
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a split-second.
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Or it can be a deliberate decision to quit sports and begin anew, which can also be
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traumatic.
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“Identity gets so wrapped up into performance,” Brown said.
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Growing up in Steamboat Springs, Colorado, Taylor Fletcher learned to glide down mountains
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on skis by age four.
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To this day, that’s one way he relieves stress.
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Fletcher’s parents, especially his mother, made sacrifices so he and his brother could join a
24:26
local ski team coached by former Olympians who had developed a pipeline to the Winter Games.
24:33
His journey to the Olympics was not a foregone conclusion, he said, but he worked his way up,
24:39
pushed by his desire to join the national team.
24:43
For years, Fletcher said, he focused on just one thing – “everything else took a step back.”
24:50
Looking back, having an athlete’s laser-like focus could mean “you can pigeonhole yourself
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into being stuck,” said the four-time former member of the United States Nordic Combined
25:01
team.
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“They can get back up, they can continue again.
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It’s not too late, and starting today is better than starting tomorrow.”
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When athletes are contemplating retirement, Bartley and her staff encourage them to reach
25:15
out to their support networks, including family, friends and peers in their sport, she
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said, but also to reflect on what they want.
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Over the years, Team USA developed its Pivot Program, designed to help athletes cope as they
25:30
transition into the next phase of their life.
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Experts talk to current and former athletes about job training skills and financial
25:37
literacy, preparation for higher education as well as mental health and well-being.
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“That’s one thing I wish I knew,” Fletcher said.
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“While the sport is a big deal, it is not everything.”
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In life after the Olympics, Ohno said he has failed countless times.
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What has helped him recover has been his desire to encourage people to “be open and receptive
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and vulnerable to listening with empathetic ears” and “to help others recognize and guide
26:06
them to their own inner truths.”
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“They can get back up, they can continue again,” he said.
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“It’s not too late, and starting today is better than starting tomorrow.”
26:17
As we head into the heart of summer, many of us are eager to get back into our favorite sports
26:22
and outdoor activities.
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But whether you are a seasoned athlete or just looking to join a friendly game of kickball,
26:28
avoiding injuries is key to enjoying the season.
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Today, we are sharing some expert tips from professional coaches that will help you stay
26:36
active and injury-free during your summer sports adventures.
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Jason Glass, a top performance coach who trains elite athletes on the PGA Tour, emphasizes the
26:48
importance of daily habits.
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He says, "Whether you are a professional athlete or a weekend warrior, you cannot
26:55
prepare for game day on game day.
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Proper preparation comes from your daily habits."
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Glass recommends creating a daily lifestyle checklist he calls his "Foundational Five":
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1.
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Sleep like it is your job: Quality sleep is essential for recovery and performance.
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Aim for consistent, restful sleep.
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2.
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Stay hydrated: Drink half your body weight in fluid ounces per day.
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For a 200-pound athlete, that is 100 ounces daily.
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3.
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Eat clean: Know what is in your food and how it affects your body.
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This awareness helps you make better choices on game day.
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4.
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Move beautifully: Engage in an activity every day that makes you feel great, whether it is
27:44
yoga or weight lifting.
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Listen to your body.
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5.
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Live with intention: Train with specific outcomes in mind.
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Even napping can be beneficial if done with the intention of resting up before a big game.
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Glass advises that you score yourself on each of these five foundations at the end of each
28:05
day, using a scale of zero to five.
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Aim for twenty or more total points at the end of each day.
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"Master these five foundations before adding any other performance-enhancing modalities," he
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suggested.
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Next, we have tips from Bill Burgos, the former head of strength and conditioning for three NBA
28:25
teams.
28:26
He offers advice for those returning to sports after a hiatus.
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"For someone who has not participated in any sporting activity for quite some time, it is
28:35
crucial to start safely and effectively," he noted.
28:39
Burgos' three tips are:
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1.
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Prepare your body for movement: Use foam rolling and dynamic stretching exercises such
28:48
as walking lunges with elbow-to-instep and walking knee hugs to enhance flexibility and
28:53
mobility.
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2.
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Gradually elevate your heart rate: Begin with low-intensity activities such as a slow jog and
29:01
progressively increase to a moderate intensity that mimics your sport.
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3.
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Listen to your body: Pay attention to how your body feels and adjust the intensity of your
29:11
workout accordingly.
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Paul Fournier, a strength and conditioning coach for the Los Angeles Dodgers who has
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worked in Major League Baseball for over thirty years, highlights the importance of strength
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and speed for longevity and injury prevention.
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"Maintaining strength and speed of movement is key to preventing chronic pain and injuries,"
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he asserted.
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Fournier recommends incorporating calisthenics, weight training, sprint work, and plyometrics
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into your routine.
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He suggests starting with twice-weekly sessions that include:
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1.
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Low-level plyometrics: Jump rope, step-ups, and light medicine ball work will build
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neurological and muscular endurance.
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2.
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Core strengthening: Perform exercises such as planks, dead bugs, and rollouts to enhance
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torso stability and protect your back.
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3.
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Strength training: Focus on compound movements for the lower body with exercises such as
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lunges and squats while incorporating more isolating upper-body exercises like chest
30:19
presses, rows, and curls.
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Matt Nichol, a coach with three decades of experience training professional and Olympic
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athletes, emphasizes the critical role of a proper warm-up.
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"The warm-up is as important as the workout," he said.
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Nichol offers these practical warm-up tips:
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1.
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Arrive early: Just like professional athletes who arrive at least three hours early on game
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days, give yourself extra time before your recreational activity or competition to warm
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up.
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2.
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Walk more: Park farther away to incorporate some light movement as you walk to your
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activity.
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3.
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Get warm: Avoid stretching cold muscles.
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Instead, perform sport-specific movements (i.e., running, dribbling, swinging a bat or
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racquet, etc.) at a lower intensity and gradually increase speed until you are at game
31:14
speed.
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4.
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Listen to your body’s cues: Pay attention to any aches and pains during your warm-up.
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These can be early warnings of injury potential.
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It is better to dial back your intensity for one game than to push too hard and miss the
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entire season.
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Dana Santas, a mobility coach in professional sports for more than twenty years, underscores
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the importance of sport-specific mobility.
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She encourages athletes to follow these three strategies:
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1.
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Have clear goals and a plan to achieve them: Your objectives should align with the needs of
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your sport and provide direction for your mobility program.
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For instance, if you want to get back into playing golf, tennis, or any other rotational
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sport, focus on mobility exercises that will improve rotation.
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2.
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Build strong, powerful movements: Enhanced movement that improves sports performance
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requires strength and power behind the movement.
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Core strengthening is essential for stabilizing the low back and preventing injury.
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Building core strength and stability also provides a foundation for expressing power
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through spine and limb movements.
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3.
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Train for controlled movement: Avoid solely relying on stretching to create passive ranges
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of motion that could lead to injury during activity.
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Instead, focus on targeted strength and mobility exercises that promote control in end
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ranges of motion.
32:44
For example, rather than doing seated toe touches as a passive hamstring stretch,
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practice single-leg Romanian dead lifts that lengthen and strengthen hamstrings while also
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promoting stable and mobile pelvic movement.
32:56
Before you jump into the next neighborhood pickup basketball game or sign up for the town
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softball league, take these practical insights to heart to enhance your performance and reduce
33:06
your risk of injury.
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That is all for today’s episode of Morning Medical with Dr.
33:11
Chow.
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Stay safe, stay active, and we will see you next time with more medical and health updates.
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Have a great day!