Latest news with #non-FDA-approved
Axios
5 days ago
- Health
- Axios
Women drive Arkansas GLP-1 weight-loss surge
Women are being prescribed GLP-1 weight-loss drugs at higher rates than men, new data shows. Why it matters: This is another cultural moment when women, especially those approaching menopause, are paying more for their well-being. Between the lines: GLP-1 drugs like Ozempic and Mounjaro are usually covered by insurance when used to treat Type 2 diabetes — but many doctors also prescribe them off-label for overweight and obesity, which often isn't covered. Zoom in: In Arkansas, women have been prescribed GLP-1 drugs at higher rates than men since 2020, and the rate of women prescribed the drug has more rapidly increased, according to 2024 data from FAIR Health. The fine print: The data reflects insured adults who received medical care nationally, but doesn't include people buying non-FDA-approved versions of the drugs from compounding pharmacies. The big picture: Nationally, 18.6% of women prescribed GLP-1 drugs received them for weight loss (and not diabetes) — double the rate of men, at 9.3% — according to FAIR Health. Women between 40 and 64 have been the top recipients of GLP-1 prescriptions since 2019. For men, the top users in most years have been seniors. What we're hearing:"In my experience, thus far, it's been entirely women" — many of them approaching menopause — who ask to be on GLP-1 drugs to lose weight, says family physician Beth Oller, who practices in rural Kansas. At a certain age, "the things you used to do for weight loss aren't cutting it anymore," says Oller, who's 45 and tells Axios she has firsthand experience with this.
Axios
25-06-2025
- Health
- Axios
Women approaching menopause drive GLP-1 boom
Women are being prescribed GLP-1 weight-loss drugs at higher rates than men, new data shows. Why it matters: This is another cultural moment when women, especially those approaching menopause, are paying more for their well-being. Between the lines: GLP-1 drugs like Ozempic and Mounjaro are usually covered by insurance when used to treat Type 2 diabetes — but many doctors also prescribe them off-label for overweight and obesity, which often isn't covered. By the numbers: Women have been prescribed GLP-1 drugs at higher rates than men since 2021, according to 2024 data from FAIR Health. The fine print: The data reflects insured adults who received medical care nationally, but doesn't include people buying non-FDA-approved versions of the drugs from compounding pharmacies. Zoom in: 18.6% of women prescribed GLP-1 drugs received them for weight loss (and not diabetes) — double the rate of men, at 9.3% — according to FAIR Health. Women between 40 and 64 have been the top recipients of GLP-1 prescriptions since 2019. For men, the top users in most years have been seniors. What we're hearing:"In my experience, thus far, it's been entirely women" — many of them approaching menopause — who ask to be on GLP-1 drugs to lose weight, says family physician Beth Oller, who practices in rural Kansas. At a certain age, "the things you used to do for weight loss aren't cutting it anymore," says Oller, who's 45 and tells Axios she has firsthand experience with this.
Associated Press
24-06-2025
- Business
- Associated Press
ZEO ScientifiX Launches Physician-Focused Masterclass Ahead of Florida's SB-1768 Law Implementation
FORT LAUDERDALE, FL / ACCESS Newswire / June 24, 2025 / ZEO ScientifiX, Inc. ('ZEO' or the 'Company') (OTCQB:ZEOX), a clinical-stage biopharmaceutical company pioneering the research and development of innovative biological therapeutics, has announced their upcoming ZEO Masterclass - a physician-led initiative designed to educate Florida doctors on one of the most significant regulatory changes in recent healthcare history. The New Frontier in Regenerative Medicine With Florida's SB-1768 law ('Law') set to take effect on July 1, 2025, licensed MDs and DOs will, for the first time in accordance with the terms of the Law, be authorized to offer non-FDA-approved stem cell therapies directly to patients in defined medical indications and only if conducted under strict compliance protocols. This legislative breakthrough introduces transformative potential across multiple specialties, including: While this Law opens clinical and commercial doors to ZEO that, until now, have previously been unavailable unless such products were FDA approved, it also presents a complex and unfamiliar landscape for physicians who will be obligated to comply with the regulations outlined under the Law. That is why ZEO is stepping in to serve as a bridge between this groundbreaking legislation and responsible, compliant medical practice. 'As a company with deep roots in Florida, a strong research foundation and an FDA-registered facility, we are uniquely positioned to be the state's most trusted source for safe, high-quality stem cell products that are within the guidelines of the new law,' said Ian Bothwell, interim chief executive officer of ZEO ScientifiX. 'We're proud to support physicians in their desire to incorporate innovative solutions that meet the highest standards of science, ethics and patient care.' The ZEO Masterclass: Designed for Today's Physician-Pioneers Unlike any other offering in the field, the ZEO Masterclass is a four-hour intensive training created specifically for physicians ready to lead this new era of regenerative medicine. From legal compliance to clinical integration, the curriculum delivers: Attendees will receive direct instruction from leading experts in biologics and compliance - equipping them to implement regenerative therapies responsibly and confidently. Upcoming Event Details ZEO Masterclass on Stem Cells & Exosomes Date: Friday June 27th Time: 9:00 AM - 2:00 PM (Lunch Included) Location: Alvin Sherman Library, 5th Floor Address: 3100 Ray Ferrero Jr Blvd, Davie, FL 33314 Hosted at NOVA Southeastern University, South Florida Physicians ready to lead the future of healthcare can register now at ZEO's website or contact [email protected] for more information. About ZEO ScientifiX, Inc. ZEO is not just keeping pace with regulatory change - we're setting the standard. As a clinical-stage biopharmaceutical company focused on the development of biological therapeutic platforms, we believe that when physicians are educated, patients are better served - and innovation thrives. We are driven by a commitment to advance the frontiers of regenerative medicine and biologic therapeutics, delivering meaningful solutions for patients and providers worldwide. Our proprietary products, including (a) Zofin™, which are derived from perinatal sources and manufactured to retain the naturally occurring extracellular vesicles, proteins and cell secreted nanoparticles and (b) Patient Pure X™ ('PPX™"), an autologous biologic containing a nanoparticle fraction that is precipitated from a patient's own peripheral blood. During November 2024, the Company announced that it was launching the first planned collaborative product with Exotropin; 'ZEO HAIR GROW™ Powered By Exotropin™", a proprietary topical physician formulated hair regrow system. The Company's proprietary products are manufactured in an FDA-registered, cGMP-compliant laboratory. To learn more, please visit Forward-Looking Statements Certain statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the 'Securities Act'), the Securities Exchange Act of 1934, as amended (the 'Exchange Act'), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as 'will,' 'believes,' 'expects,' 'potential,' or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks, and uncertainties, and these expectations may prove to be incorrect. No assurances can be given that the Florida Stem Cell Law will be beneficial to the Company or any initiatives related to this new law will increase the price of our common stock to a level that is attractive to brokerage houses and institutional investors. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations, including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally, and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website ( You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. ZEO has no intention and specifically disclaims any duty to update the information in this press release. Contact Information Chloe Detrick Plus4 Public Relations [email protected] SOURCE: Zeo ScientifiX, Inc. press release
Yahoo
07-06-2025
- 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
05-06-2025
- 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
