Latest news with #non-FDA-approved
Yahoo
a day ago
- Health
- Yahoo
Botulism cases linked to Botox injections under investigation in Massachusetts
Massachusetts health officials are investigating four recent cases of suspected botulism connected to cosmetic injections of Botox. The outbreak on the South Shore prompted the Department of Public Health to warn health care providers to be alert about symptoms. consistent with botulism occurring after botulinum toxin injections. Botox is widely used for cosmetic purposes to reduce wrinkles and fine lines. 'While generally safe when administered by trained professionals, improper dosing, administration technique, or use of non-FDA-approved products may increase the risk of systemic botulism symptoms,' the DPH advisory said. Botulism, though rare, can be fatal. It occurs when botulinum toxin enters the bloodstream and can produce effects far from the injection site, according to the advisory. Initial botulism symptoms include double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing and breathing problems, according to state health officials. These symptoms may progress to muscle weakness that worsens over hours to days. Anybody who is experiencing any symptoms should go to an emergency room. 'This is very rare,' South Shore Hospital infectious disease specialist Dr. Todd Ellerin told WCVB. 'We call it iatrogenic botulism, which means you get it as a complication of an injection. It is very rare.' The DPH has not released details about the condition of the four individuals involved in the South Shore cases or information about the provider or facility where they received their injections. How pink heart shaped fentanyl led to Mass. father's 18-year prison sentence ICE deportation blocked by Boston judge: Migrants now in shipping container in Djibouti Mass. State Lottery winner: Father will take children to Disney with $100K prize Former police deputy chief, school resource officer convicted of child rape Mass. casino winner: $2.50 bet won gambler jackpot prize ``` Read the original article on MassLive.
Yahoo
3 days ago
- Health
- Yahoo
Four botulism cases linked to cosmetic Botox on South Shore, Mass. public health officials say
State public health officials are investigating four recent botulism cases that are linked to cosmetic Botox injections on the South Shore. In a clinical advisory to health care providers on Thursday, Department of Public Health officials urged providers to 'be alert' for symptoms consistent with botulism occurring after botulinum toxin injections. State officials did not disclose where the four cases were reported on the South Shore. 'These cases highlight the risk of iatrogenic botulism, a rare but serious adverse event resulting from the administration of botulinum toxin products,' the advisory states. 'DPH is advising healthcare providers to be alert for symptoms consistent with botulism occurring after botulinum toxin injections.' Botulinum toxin, known commonly as Botox, is widely used for cosmetic purposes to reduce wrinkles and fine lines. Experts say while generally safe when administered by trained professionals, improper dosing, administration technique, or use of non-FDA-approved products may increase the risk of systemic botulism symptoms. Botulism is the rare and sometimes fatal disease caused by botulinum toxin circulating in the blood and producing effects remotely from the injection site. There may be symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin, especially in the head and neck, and the early symptoms of botulism. 'Healthcare providers should be alert for symptoms consistent with botulism occurring after botulinum toxin injections,' state public health officials said in their advisory. Initial botulism symptoms may include double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and difficulty breathing, officials said. These symptoms may be followed by a descending, symmetric muscle weakness that progresses over hours to days. State officials said symptoms to watch out for include: Muscle weakness, especially in areas beyond the injection site. Note especially symmetric or bilateral weakness in distinction to localized weakness at or near the injection site, which is expected. Dysphagia (difficulty swallowing) Dysarthria (speech difficulties) Ptosis (drooping eyelids) Respiratory difficulty Other cranial nerve palsies Symptoms may develop hours to days post-injection. State officials offered the following guidance for clinicians: Maintain a high index of suspicion for botulism in patients presenting with compatible symptoms following cosmetic Botox or other botulinum toxin injections. Obtain a detailed history of recent botulinum toxin exposure, including the name and location of the injecting provider and any available information about the brand, lot and dose. Report suspected cases immediately to the Massachusetts Department of Public Health by calling 617-983-6800 (24/7) or to the local board of health Coordinate prompt clinical management, including supportive care and consideration of botulinum antitoxin administration when indicated. Early treatment can improve outcomes. Counsel patients who report using or being interested in using botulinum toxin about potential adverse effects. Advise patients to receive injections only from licensed providers who are trained in proper administration of FDA-approved botulinum toxin products, preferably in a licensed or accredited healthcare setting. 'MDPH is actively investigating these cases to identify the source and prevent further incidents,' the advisory states. 'Clinicians are urged to report any suspected cases promptly to facilitate timely public health response.' Anyone with additional information or questions is urged to contact the Massachusetts Department of Public Health at 617-983-6800. This is a developing story. Check back for updates as more information becomes available. Download the FREE Boston 25 News app for breaking news alerts. Follow Boston 25 News on Facebook and Twitter. | Watch Boston 25 News NOW
Yahoo
12-02-2025
- Health
- Yahoo
Hims & Hers Super Bowl ad sparks weight-loss drug backlash
(NewsNation) — Telehealth company Hims & Hers is being called out over its Super Bowl ad going after Big Pharma and popular weight-loss injections. The ad highlights compounded versions of the drugs, which are cheaper than brand-name alternatives like Novo Nordisk's Wegovy and Ozempic. It also touts a non-FDA-approved Hims & Hers weight-loss drug as the supreme and affordable solution to America's obesity epidemic and has sparked backlash for perceived fat-shaming and political pandering. Critics argue that while Hims & Hers criticizes the nation's food corporations and health care as greedy and broken, the company itself is part of the problem, leaving out crucial health risks and dangerous side effects. Dr. Heather Hirsch, a board-certified internist, warns that compounded medications can be risky and lack the rigorous FDA approval process of brand-name drugs. Flu activity highest in 15 years: Which states have it worst? 'When we start compounding things and we remove some of the regulation, it is a little bit of the wild, wild west. Now, we could say 95% of it is going to be safe and effective, but would you want to be the one person who gets the vial that's not? And there's been cases of meningitis. There's been cases of bacterial infections from compounded pharmacies because these medications don't carry the same approval or rigorous process that FDA-approved medications do,' Hirsch said. The Hims & Hers version of the weight-loss drug is a compounded drug, essentially a mixture of individual drugs that creates a near copy of the brand versions. It's currently allowed to skirt FDA regulations and avoid the strict approval processes that big-name drugs like Ozempic, Wegovy and Monjaro undergo. 'With every batch of semaglutide that they produce, there's something called the certificate of analysis CoA, and that CoA does somewhere between 10 and 15 tests,' Dr. Craig Primack, the head of weight management at Hims & Hers said. 'To give you confidence that what you're getting is the compounded drug and it does not have contaminants.' Hims & Hers stands by its safety protocols, emphasizing patient care and accessibility. A doctor from the company told NewsNation they defended its compounded drugs, claiming they undergo testing for safe concentration levels and viruses and bacteria. Nearly everyone in the world breathes bad air. How to lower your risk Hims & Hers said it is following the law, cares about its patients, and believes its drug is helping Americans with 'both access and affordability.' In response, Ozempic and Wegovy have published full-page ads questioning the safety of the compounded drugs. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
