A deadly E. coli outbreak hit 15 states, but the FDA chose not to publicize it
An E. coli outbreak linked to romaine lettuce ripped across 15 states in November, sickening dozens of people, including a 9-year-old boy in Indiana who nearly died of kidney failure and a 57-year-old Missouri woman who fell ill after attending a funeral lunch. One person died.
But chances are you haven't heard about it.
The Food and Drug Administration indicated in February that it had closed the investigation without publicly detailing what had happened — or which companies were responsible for growing and processing the contaminated lettuce.
According to an internal report obtained by NBC News, the FDA did not name the companies because no contaminated lettuce was left by the time investigators uncovered where the pathogen was coming from.
'There were no public communications related to this outbreak,' the FDA said in its report, which noted that there had been a death but provided no details about it.
Federal officials are not required by law to reveal detailed information about all known outbreaks of foodborne illnesses, and there are reasons the FDA may choose not to publicize an outbreak, including when the cause is unknown or when officials are still working behind the scenes with the companies responsible.
But the FDA had shifted in recent years toward greater transparency in the wake of large-scale outbreaks and heightened public concern about contaminated food, said Frank Yiannas, the former deputy commissioner of food policy and response at the agency.
'It is disturbing that FDA hasn't said anything more public or identified the name of a grower or processor,' said Yiannas, who was at the FDA from 2018 to 2023.
By declining to name the culprit, he said, the FDA was withholding critical information that consumers could use to make decisions about what they buy. It's also possible that someone could have been sickened during the outbreak and not have realized the cause, and serious bacterial illness can cause long-term damage.The FDA, which is a part of the Department of Health and Human Services, denied that its response to the recent E. coli outbreak marked any shift in policy.
'The FDA names firms when there is enough evidence linking an outbreak to a firm and there is actionable advice for consumers, as long as naming the firm is not legally prohibited,' a spokesperson said in a statement to NBC News. 'By the time investigators had confirmed the likely source, the outbreak had already ended and there was no actionable advice for consumers.'
Food safety advocates argue that disclosing such information is still critical to ensure that people will dispose of contaminated food they may have frozen and stored and to allow consumers to make informed choices.
'People have a right to know who's selling contaminated products,' said Sandra Eskin, a former official at the U.S. Agriculture Department who now works as a food safety advocate.
But much of the staff responsible for developing and distributing information to the public about foodborne illnesses was terminated this month as part of the Trump administration's sweeping effort to shrink the federal government.
'We no longer have all the mechanisms in place to learn from those situations and prevent the next outbreak from happening,' said Taryn Webb, who led the FDA's public engagement division for human foods until she was laid off during the mass firing this month.
And the administration has separately moved to delay a new federal rule requiring food companies and grocery stores to rapidly track down contaminated food and pull it off the shelves, though the FDA said the delay was meant to give time to ensure better compliance.
The FDA said its staff members 'continue to provide critical communications to consumers associated with foodborne outbreaks,' including information about recalls and investigations.
The morning the first cases of E. coli started coming in, Dr. Amanda Brzozowski sensed something was very wrong.
It was early November, and all three were E. coli 0157:H7 — an especially dangerous strain that can result in severe illness, organ damage and, in rare cases, death — and the people sickened were all high school students who lived in the same area of St. Louis County.
Brzozowski, a senior epidemiologist for the county, immediately reached out to the school they attended, and, within hours, more families were reporting symptoms of E. coli infection: bloody diarrhea, stomach cramps, vomiting and dehydration.
Ultimately, the county Public Health Department found 115 confirmed or probable E. coli cases linked to food served by a local catering company — and that the salads they ate were a likely culprit. The catering company has declined to comment.
'It was really scary,' Brzozowski told NBC News. 'This type of situation we've never seen before.'
The victims included 15-year-old Austin Carnaghi, who opted for more salad instead of a brownie at his marching band's annual banquet before he developed severe stomach pain and needed to be hospitalized, according to his mother, Kristiana Carnaghi. 'It was an unbelievable amount of cramping,' she said.
Miles away in Indiana, the same strain of E. coli had stricken another boy.
The morning after he played basketball, Colton George, 9, woke up and was doubled over in pain. His parents rushed him to the hospital, where testing confirmed the presence of E. coli 0157:H7.
He had developed hemolytic uremic syndrome, a life-threatening complication from the E. coli infection, and needed to be put on around-the-clock dialysis, without food or drink for days.
His parents, Christopher and Amber George, tried to prepare Colton for what was happening. 'Unfortunately, if we don't do this,' his mother said she told him, 'there is a chance you won't make it.'
Colton was on dialysis in a hospital bed for two weeks — including over his 10th birthday — before he was released. Months later, he is back to playing basketball but still experiences chronic stomach pain and fatigue because of the complications.
And his parents have been wrestling with the same question ever since the doctors told them that the E. coli must have come from something Colton had eaten.
'Where did he get this from?' his father said. 'Something must have gone wrong somewhere.'
Colton's parents say it wasn't just a coincidence their son had symptoms similar to those of the Missouri high-school students, around the same time and with the same diagnosis of E. coli 0157:H7.
The bacteria that infected them had the same genetic sequencing, according to a lawsuit by the Georges that alleges the tainted produce came from Taylor Farms, one of the country's largest producers of salads and fresh cut vegetables.
Public health officials use genetic fingerprints of bacteria to help pinpoint the source of foodborne illnesses. In late November, FDA officials were alerted to a cluster of E. coli O157:H7 cases after Missouri officials investigated the cases linked to the catering company, according to the FDA's report on the outbreak.
The genomic fingerprint of the pathogen was also posted to a national laboratory network for tracking foodborne illnesses.
That data was used to help connect 89 cases across 15 states: The youngest victim was 4, and the oldest was 90. They all first had symptoms in November; more than a third were hospitalized, and seven had developed hemolytic uremic syndrome, a disease that affects kidney function. But the number of probable cases local health officials tallied was significantly higher, since not all victims went to the hospital and had samples that were genetically sequenced, Brzozowski said.
Using the genetic analysis, local health surveys and other evidence, federal investigators came to a conclusion. 'Based on epidemiologic and traceback data, romaine lettuce was confirmed as the source of this outbreak,' according to the report, which noted the contaminated produce came from 'a sole processor' that had obtained the lettuce from a grower.
But the FDA redacted the name of the companies that processed and grew the lettuce before it released the report in response to a public records request filed by the Georges' attorney, Bill Marler.
As part of the lawsuit, Marler obtained receipts, also reviewed by NBC News, that he says show the salad linked to the outbreak originally came from Salinas, California-based Taylor Farms, which supplies major supermarkets and chain restaurants across the country.
The Georges, the Carnaghis and other victims have all accused Taylor Farms in nine different lawsuits, arguing in court papers that it sold 'defective and unreasonably dangerous' food products.
Taylor Farms denied that any of its products were responsible for the outbreak.
'We don't believe Taylor Farms was the source of the referenced recent E. coli outbreaks, based on information collected during thorough third-party investigations and robust food safety controls,' it said in a statement.
Asked whether Taylor Farms had produced the contaminated lettuce involved in the outbreak, the FDA said in a statement that it was restricted by federal law from disclosing 'confidential commercial information.'
The accusations against the company come on the heels of another deadly outbreak: In October, just weeks before the St. Louis cases surfaced, Taylor Farms had voluntarily recalled yellow onions linked to a separate E. coli outbreak — one that also infected more than 100 people and killed one.
In that case, though, the FDA issued an advisory notifying the public about the contaminated onions, which were served on McDonald's hamburgers, making headlines across the country.
Taylor Farms said it would always act out of an abundance of caution to protect consumers. It added that it had robust food safety and pathogen testing procedures and that onion samples that health officials had taken at McDonald's restaurants had tested negative for E. coli O157:H7.
On the romaine lettuce outbreak, the FDA said only that it was investigating an E. coli O157:H7 outbreak involving 89 cases.
In mid-January, the Centers for Disease Control and Prevention declared the outbreak was over, according to a letter sent to state health departments obtained by NBC News. And in February, the FDA moved its outbreak investigation from 'active' to 'closed,' without providing further details, according to archived versions of its website.
The full scope of the outbreak came to light only in response to the public records requests filed by the victims' attorneys.
Even in outbreaks without recalled products, Yiannas said, he pushed the FDA to publish more advisories describing the cases and where they occurred, the symptoms to watch for and the brands of contaminated food that were sold, as well as investigative reports detailing the FDA's findings.
In 2022, for instance, the FDA issued public health advisories in cases of hepatitis A in fresh strawberries and E. coli in packaged salad greens, even though they were not subject to recalls and were no longer sold.
The FDA told NBC News that it had issued such statements because 'consumers could have frozen product for later use' and the outbreaks were still ongoing when it pinpointed the source, unlike with the 2024 E. coli case linked to romaine lettuce.
Federal officials may also hold off on making public statements while they are privately pushing food growers and processors to change their safety practices and procedures or because elements are still under investigation, former FDA staff members said. Other times, the federal government may not have enough definite evidence to pinpoint the source of an outbreak.
It's especially challenging for FDA investigators to hunt down and identify foodborne illness linked to fresh produce, because the products have a short shelf life compared to canned goods, which can be stored for years. Highly perishable, fresh produce is often considered out of circulation once it is no longer available for sale.
But publicly identifying the source can help pressure companies to adopt and improve practices to prevent food from being contaminated in the first place, said Barbara Kowalcyk, a professor and food safety expert at George Washington University.
E. coli cases can stem in some cases from contamination between animal waste and produce while fruits and vegetables are still being grown in fields, because of runoff from livestock farms, the design of irrigation systems or even extreme weather that results in an unexpected flooding of contaminated water.
'The whole purpose of investigating these outbreaks is to stop the illnesses and to learn how to prevent future outbreaks,' Kowalcyk said. 'If you don't come out and talk about what happened, we've lost that opportunity.'
And the FDA's reticence about the romaine lettuce outbreak has angered families like the Georges, who say they are still struggling to pay off about $20,000 in medical bills while their son continues to recover. Even if that contaminated lettuce is no longer sold, they believe the public has a right to know.
'It's not fair for them to get off the hook,' Amber George said. 'People are still going out and buying their product every day and have no idea what happened.'
This article was originally published on NBCNews.com

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Associated Press
an hour ago
- Associated Press
Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 15, 2025-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. Sarepta is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for ELEVIDYS. This panel will evaluate data and assess our proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. Suspending Shipments of ELEVIDYS for Non-Ambulatory Patients: Sarepta is temporarily suspending shipments of ELEVIDYS for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after ELEVIDYS infusion, along with post-treatment monitoring, remains the same. ENVISION Study Paused: Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). FDA concurs with this action. The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume. ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating ELEVIDYS in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy. In the U.S., it serves as the confirmatory trial required under the FDA's accelerated approval pathway for non-ambulatory patients. 'Our paramount priority is the safety and well-being of the patients we serve. We are taking immediate, decisive steps to better understand and mitigate the risk of acute liver failure, including enhancing the immunosuppressive regimen, for those with Duchenne who are non-ambulatory,' said Louise Rodino-Klapac, Ph.D., chief scientific officer and head of research & development, Sarepta. 'We are deeply saddened by the loss of a second patient and extend our heartfelt condolences to the patient's family and his care team during this incredibly difficult time. Duchenne muscular dystrophy is a devastating disease that profoundly affects lives and often cuts them far too short. With more than 900 individuals treated to-date, we know how much hope families place in new treatment options like ELEVIDYS – and we are committed to honoring that hope by acting swiftly, guided by scientific rigor and the insights of leading experts, to strengthen safety for all future patients.' Commitment to Long-Term Safety and Understanding Sarepta remains committed to a thorough approach and the highest standards of patient safety and scientific rigor. The event has been reported to FDA and global health authorities and will inform ongoing discussions around a potential label update to reflect the risk of severe ALF and additional immune management strategies for non-ambulatory patients. While elevated liver enzymes are a known class effect of all AAV-based gene therapies, the exact mechanism behind AAV-related liver toxicity remains unclear. Current evidence suggests it is likely driven by an adaptive immune response. The Company will provide additional updates as appropriate. Investor Conference Call Details Sarepta will be hosting a conference call and webcast to discuss this update and provide an update on the Company's business on Monday, June 16, 2025, at 8:00 am Eastern time. The event will be webcast live under the investor relations section of Sarepta's website at: and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Acute Serious Liver Injury: Immune-mediated Myositis: Myocarditis: Preexisting Immunity against AAVrh74: Adverse Reactions: Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to source version on CONTACT: Investor Contact: Ian Estepan 617-274-4052 [email protected] Contacts: Tracy Sorrentino 617-301-8566 [email protected] Hoeger 617-710-3898 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: INFECTIOUS DISEASES HEALTH GENETICS PHARMACEUTICAL CLINICAL TRIALS SOURCE: Sarepta Therapeutics, Inc. Copyright Business Wire 2025. PUB: 06/15/2025 01:00 AM/DISC: 06/15/2025 01:01 AM


Business Wire
4 hours ago
- Business Wire
Sarepta Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. Sarepta is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for ELEVIDYS. This panel will evaluate data and assess our proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. Suspending Shipments of ELEVIDYS for Non-Ambulatory Patients: Sarepta is temporarily suspending shipments of ELEVIDYS for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after ELEVIDYS infusion, along with post-treatment monitoring, remains the same. ENVISION Study Paused: Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). FDA concurs with this action. The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume. ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating ELEVIDYS in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy. In the U.S., it serves as the confirmatory trial required under the FDA's accelerated approval pathway for non-ambulatory patients. 'Our paramount priority is the safety and well-being of the patients we serve. We are taking immediate, decisive steps to better understand and mitigate the risk of acute liver failure, including enhancing the immunosuppressive regimen, for those with Duchenne who are non-ambulatory,' said Louise Rodino-Klapac, Ph.D., chief scientific officer and head of research & development, Sarepta. 'We are deeply saddened by the loss of a second patient and extend our heartfelt condolences to the patient's family and his care team during this incredibly difficult time. Duchenne muscular dystrophy is a devastating disease that profoundly affects lives and often cuts them far too short. With more than 900 individuals treated to-date, we know how much hope families place in new treatment options like ELEVIDYS – and we are committed to honoring that hope by acting swiftly, guided by scientific rigor and the insights of leading experts, to strengthen safety for all future patients.' Commitment to Long-Term Safety and Understanding Sarepta remains committed to a thorough approach and the highest standards of patient safety and scientific rigor. The event has been reported to FDA and global health authorities and will inform ongoing discussions around a potential label update to reflect the risk of severe ALF and additional immune management strategies for non-ambulatory patients. While elevated liver enzymes are a known class effect of all AAV-based gene therapies, the exact mechanism behind AAV-related liver toxicity remains unclear. Current evidence suggests it is likely driven by an adaptive immune response. The Company will provide additional updates as appropriate. Investor Conference Call Details Sarepta will be hosting a conference call and webcast to discuss this update and provide an update on the Company's business on Monday, June 16, 2025, at 8:00 am Eastern time. The event will be webcast live under the investor relations section of Sarepta's website at: and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.


Newsweek
5 hours ago
- Newsweek
Vitamin Gummies Recalled Over Undeclared Peanut Allergen Risk
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. Vita Warehouse Corp. has voluntarily recalled three popular vitamin B12 gummy products due to potential undeclared peanut contamination, the U.S Food and Drug Administration (FDA) announced this week. Newsweek reached out to Vita Warehouse Corp. via email on Saturday for comment. Why It Matters Individuals who are allergic to peanuts have immune systems that react to peanuts, with symptoms that might include skin reactions, itching or tingling in the mouth or throat, digestive problems such as diarrhea, runny nose, tightening of the throat and shortness of breath. In severe cases, people with food allergies may go into anaphylaxis—and peanuts are the most common cause of anaphylactic allergic reactions. Anaphylaxis may involve difficulty breathing, swelling of the lips, tongue and throat, a drop in blood pressure, a rapid pulse, dizziness, lightheadedness or a loss of consciousness. June 12, 2025, Vita Warehouse Corp. is voluntarily recalling one lot of Welby® brand Vitamin B12 Energy Support gummy product 1000 mcg 140 gummies, Berkely Jensen® Vitamin B12 1000 mcg 250 Gummies, and VitaGlobe™ Vitamin... June 12, 2025, Vita Warehouse Corp. is voluntarily recalling one lot of Welby® brand Vitamin B12 Energy Support gummy product 1000 mcg 140 gummies, Berkely Jensen® Vitamin B12 1000 mcg 250 Gummies, and VitaGlobe™ Vitamin B12 Extra Strength 60 Gummies due to the potential presence of undeclared peanuts. More U.S. Food & Drug Administration/FDA What To Know The affected products include three distinct vitamin B12 formulations: Welby's 1000 mcg 140-count gummies in green, red, and white packaging (UPC: 4099100290868); Berkley Jensen's 1000 mcg 250-count gummies in red and pink labeling (UPC: 888670132487) VitaGlobe's Extra Strength 60-count gummies with white and red packaging (UPC: 850005214670) All products feature clear bottles with white caps, with lot codes and expiration dates printed on bottle bottoms. No illnesses or allergic reactions have been reported to date. Consumers should check these details before use, as only products with lot number 248046601 and October 2026 expiration dates are affected. The recall spans multiple distribution channels, including physical ALDI and BJ's locations nationwide, plus online sales through company websites and Amazon. Vita Warehouse Corp. emphasized that no other products under these brand names are affected by the recall. What People Are Saying Vita Warehouse Corp. Statement: "This voluntary recall was initiated out of an abundance of caution to ensure consumer safety and trust. We are committed to maintaining the highest product safety and quality standards." 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." June 12, 2025, Vita Warehouse Corp. is voluntarily recalling one lot of Welby® brand Vitamin B12 Energy Support gummy product 1000 mcg 140 gummies, Berkely Jensen® Vitamin B12 1000 mcg 250 Gummies, and VitaGlobe™... June 12, 2025, Vita Warehouse Corp. is voluntarily recalling one lot of Welby® brand Vitamin B12 Energy Support gummy product 1000 mcg 140 gummies, Berkely Jensen® Vitamin B12 1000 mcg 250 Gummies, and VitaGlobe™ Vitamin B12 Extra Strength 60 Gummies due to the potential presence of undeclared peanuts. More U.S. Food & Drug Administration/FDA What Happens Next Consumers who purchased affected products should immediately stop using them and return items to their place of purchase for full refunds or dispose of them safely. Those experiencing allergic reactions should seek immediate medical attention. Vita Warehouse Corp. has established a consumer hotline at 1-855-214-0100, operating Monday through Friday from 7:30 AM to 4:00 PM EST, to address customer questions and concerns.