FDA requires updated warning about rare heart risk with COVID shots
WASHINGTON — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.
Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.
In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.
Specifically, the new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old. The label also notes that the problem has been most common among males ages 12 to 24. The previous label said the problem mostly occurs in 12- to 17-year-olds.
The FDA's labeling change appears to conflict with some prior findings of scientists elsewhere in the U.S. government.
The Centers for Disease Control and Prevention previously concluded there was no increased risk of myocarditis detected in government vaccine injury databases for COVID-19 shots dating back to 2022. Officials also noted that cases tend to resolve quickly and are less severe than those associated with COVID-19 infection itself, which can also cause myocarditis.
The FDA announcement came as new vaccine advisers appointed by Health Secretary Robert F. Kennedy Jr. met to debate the continuing use of COVID-19 vaccines for key groups, including pregnant women. It's the first meeting of the CDC advisory panel since Kennedy abruptly dismissed all 17 members of the group, naming a new panel that includes several members with a history of anti-vaccine statements.
The FDA's label update is the latest step by officials working under Kennedy to restrict or undercut use of vaccines. FDA Commissioner Marty Makary and a top deputy recently restricted annual COVID-19 shots to seniors and other Americans at higher risk from the virus. They've also suggested seasonal tweaks to match the latest circulating virus strains are new products that require extra testing.
Outside experts said the new warning is the wrong approach.
'They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution,' said Dr. Robert Morris, a public health specialist at the University of Washington. 'We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk.'
Makary and several other FDA officials gained prominence during the pandemic by suggesting the federal government exaggerated the benefits of COVID-19 boosters and downplayed serious side effects, including myocarditis.
Before joining the government, Makary and two of his current FDA deputies wrote a 2022 paper that said mandating booster shots in young people would cause more vaccine-related injuries than prevented hospitalizations from COVID-19 infections. The conclusion contradicted that of many leading vaccine and public health experts at the time, including at the CDC.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Washington Post
27 minutes ago
- Washington Post
FDA requires updated warning about rare heart risk with COVID shots
WASHINGTON — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men. Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.
Newsweek
an hour ago
- Newsweek
Chocolates Recall Map Shows States With New Warning
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Kilwins Quality Confections, LLC, is voluntarily recalling its Mocha Truffles due to fears the product may contain undeclared pecans. Newsweek reached out to the company via email for comment Wednesday night. Why It Matters Numerous recalls have been initiated in 2025 due to the potential of damaged products, foodborne illness, contamination and undeclared food allergens. Millions of Americans experience food sensitivities or allergies every year. According to the Food and Drug Administration (FDA), the nine "major" food allergens in the U.S. are eggs, milk, fish, wheat, soybeans, Crustacean shellfish, sesame, tree nuts and peanuts. The agency also warns that people with an allergy or severe sensitivity to pecans potentially "run the risk of serious or life-threatening allergic reaction if they consume these products." What To Know In the alert, the FDA says the mocha truffles may have been sold at nine Kilwins retail stores across seven states, including one in Orange Beach, Alabama, at 4751 Main St., Unit F113, along with three in Florida, in Winter Park, Coral Springs and Vero Beach. The additional sites include Thomasville, Georgia; Annapolis, Maryland; Portsmouth, New Hampshire; Alexandria, Virginia; and the 16 Market Street store in Wilmington, North Carolina. Below is a map highlighting the states with the potentially affected stores: The FDA alert says the recalled product may have been sold at these locations from April 28, 2025, until May 30, 2025, and the agency added that as of Wednesday, there have been no reported illnesses related to the recall. The recalled truffles were typically sold from the chocolate display cases inside stores and could be packaged in any of the following, the agency says: 4564 Family Assortment 9 oz 4565 Family Assortment 14 oz 4566 Family Assortment 28 oz 4567 Family Assortment 42 oz 4574 Truffle Assortment 5 oz 43109 Truffle Assortment 8 oz 43110 Mocha Truffles 75 oz 44121 Truffle Assortment 75 oz What People Are Saying The FDA alert, in part: "The recall was initiated after it was discovered that a product containing pecans was distributed in packaging that did not reveal the presence of pecans." In an email to Newsweek in January, the FDA said: "Most recalls in the U.S. are carried out voluntarily by the product manufacturer and when a company issues a public warning, typically via news release, to inform the public of a voluntary product recall, the FDA shares that release on our website as a public service. "The FDA's role during a voluntary, firm-initiated, recall is to review the recall strategy, evaluate the health hazard presented by the product, monitor the recall, and as appropriate alert the public and other companies in the supply chain about the recall," the FDA continued. It added: "The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, including the specific action taken by the recalling company. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled." Additional information on recalls can be found via the FDA's Recalls, Market Withdrawals, & Safety Alerts. What Happens Next Customers who have purchased the recalled mocha truffles in the mentioned time frame are urged to dispose of the product or return it to a Kilwins location for a full refund, the FDA notes. People with additional concerns may call the company at 231-347-3800 from 9 a.m. to 4:30 p.m. ET weekdays.
Associated Press
an hour ago
- Associated Press
In stressful times, our anxiety can rub off on pets. Causes and cures for pet anxiety
In this age of heightened anxiety, many of us turn to our pets for emotional support. But is our behavior increasing our furry friends' fears? The answer isn't simple, says Frankie Jackson, a veterinary nurse and animal behavior consultant, and the owner of Canine Counseling in Smyrna, Georgia. She said she's seen an increase in anxiety among her animal and human clients, but that it's hard to unwind the cause and effect. 'Dogs are incredibly responsive to our expressions, our body language and our scent,' she says. 'There is a feedback loop — the owners are nervous; the dog gets nervous. Our cortisol levels rise and fall in tandem.' Dr. Becky Peters, a veterinarian and owner of Bath Veterinary Hospital in Bath, New York, has also noticed a link between the anxiety of pets and their owners, particularly in the exam room. 'If owners try to over comfort them — lots of 'you're OK!'' in anxious voices, the animals do get more anxious. If we stay calm and quiet, they do too,' Peters says. Peters attributes much of the rise in pet anxiety to the social upheaval of the COVID years. Many animals who were acquired during the pandemic had limited opportunities to socialize with other people and pets during their peak developmental stages. After COVID, pets who were used to having their family at home experienced separation anxiety as their owners returned to work and school. 'A lot of pet anxiety comes from changes to their households,' Peters says. 'It can also occur from a lack of routine and structure and not enough physical activity.' Other components that could contribute to our pets' anxiety include unmet needs, past trauma and insufficient open spaces. 'We are asking our dogs to live in a world that isn't made for them,' she says. Try to get at the cause of your pet's anxiety Low-level stress responses in dogs, such as eating less and excessive self-grooming, are forms of communication that precede lunging and barking, Jackson says. Trying to solve reactive behaviors through obedience training without addressing the root cause can make dogs' anxiety worse. 'It's important to understand what the dogs are saying and why they're behaving the way they are. Manners and life skills are important, but it won't create happy dogs,' Jackson says. Anxiety in cats can be harder to spot, according to Jackson, because they're hard-wired to hide it. While dogs seek out their support people, cats don't feel safe expressing their vulnerability. Urinating in the house, scratching, hiding under the bed and overgrooming can be signs that your kitty is anxious. First, see a vet If your animal companion is suddenly acting out or on a licking binge, Jackson advises seeing a veterinarian to rule out a medical cause, such as pain or allergies. Veterinarians can also prescribe anti-anxiety medication and complementary treatments to promote sleep and relaxation. Peters recommends supplements for her canine clients including probiotics and the amino acids l-theanine and tryptophan (yes, the turkey coma one). For cats, she suggests using a product like Feliway that diffuses calming pheromones into the air. Learn about the breed A dog's breed might also play a part in developing anxiety. Peters says that while every dog is different, the more active herding and working breeds like shepherds and border collies can become anxious and destructive without an outlet for their energy. 'Herding breeds need space to run and jobs to do,' she says. When Tacoma, Washington, resident Shelani Vanniasinkam got her Australian shepherd puppy, Roo, she didn't know about the breed's reputation for anxiety. Her previous dog had been an easygoing husky who enjoyed pats from strangers and visits to the dog park. She quickly realized Roo was not that type of dog. 'He had a lot more needs than we anticipated,' Vanniasinkam says. 'We couldn't leave him alone for more than 30 minutes.' Vanniasinkam and her husband, Jesus Celaya, reached out to a local pet behavioralist, but it became clear that Roo's anxiety was so acute he needed medication before he could start behavior training. Should you consider meds for an anxious pet? Medication can be important in behavioral treatment, but it shouldn't be the only approach, says Peters. She usually suggests that her clients try training and routine modification first, unless their pet is causing harm to themselves or others. 'If I'm going to use meds, it's part of a greater process,' Peters says. Roo's veterinarian put him on Fluoxetine, or 'doggie Prozac,' an antidepressant commonly given to anxious pets. He also prescribed Trazodone, another antidepressant, for particularly stressful events, such as trips to the vet or a night of fireworks. After starting his medication, Roo received eight months of behavior training, during which Vanniasinkam and her husband not only changed their own approach to dog parenting but also set boundaries with friends and family. They limited Roo's interaction with other dogs, asked people to stop using their doorbell and requested that others ignore Roo when he barks. Now, when they want to take Roo for off-leash play, they book time at a local Sniffspot, which Vanniasinkam describes as 'an Airbnb for anxious and reactive dogs.' The company, which launched in 2016, allows homeowners to rent out their yards or property by the hour for solo, off-leash play or doggie playdates. 'It's sad when you can't take your dog to a dog park,' Vanniasinkam says. 'So, this option is really nice.' She says that while it was initially difficult to navigate Roo's anxiety, he is loving, family-oriented and worth the effort. 'It's hard having an anxious dog, but you can figure it out,' she says. 'It's just important to understand your dog, so you're set up for success.'
