Latest news with #non-FDA
Business Insider
4 days ago
- Health
- Business Insider
Teva announces results from a study of treatment patterns of tardive dyskinesia
Teva (TEVA) Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced results from a study of treatment patterns among patients with tardive dyskinesia residing in long-term care facilities, highlighting a critical gap in TD diagnosis and treatment. Key results from the study revealed: Of the residents being treated with antipsychotic drugs, 5.6% had a diagnosis of extrapyramidal syndrome, – a broad term used to describe any drug-induced movement disorder with no wide-treating therapeutic option – while 1.1% had a specific diagnosis of TD. The most common comorbidities observed in residents on APDs at risk for TD included dementia, chronic pulmonary disease and congestive heart failure. Moderate or severe liver disease was observed in less than1% of residents on APDs. Less than half of patients diagnosed with TD residing in LTC settings received the standard of care treatment recommended by the American Psychiatric Association – a vesicular monoamine transporter 2 inhibitor. The majority were treated with a non-FDA approved treatment, primarily benztropine, and a quarter were not treated at all. Confident Investing Starts Here:
Yahoo
6 days ago
- Business
- Yahoo
New Data from Teva Shows Substantial Rates of Undertreated Tardive Dyskinesia in Long-Term Care Settings at Psych Congress Elevate 2025
PARSIPPANY, N.J. and TEL AVIV, Israel, May 30, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a study of treatment patterns among patients with tardive dyskinesia (TD) residing in long-term care (LTC) facilities, highlighting a critical gap in TD diagnosis and treatment. "These results underscore the need for accurate diagnosis and timely treatment initiation for patients living with tardive dyskinesia in a long-term care setting,' said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "At Teva, we are committed to better understand and raise awareness of the gaps in TD care in all patients.' Key results from the study revealed: Of the residents being treated with antipsychotic drugs (APDs), 5.6% had a diagnosis of extrapyramidal syndrome (EPS), – a broad term used to describe any drug-induced movement disorder with no wide-treating therapeutic option – while 1.1% had a specific diagnosis of TD. The most common comorbidities observed in residents on APDs at risk for TD included dementia, chronic pulmonary disease and congestive heart failure. Moderate or severe liver disease was observed in <1% of residents on APDs. Less than half of patients diagnosed with TD residing in LTC settings received the standard of care treatment recommended by the American Psychiatric Association – a vesicular monoamine transporter 2 inhibitor (VMAT2i). The majority were treated with a non-FDA approved treatment, primarily benztropine, and a quarter were not treated at all. 'Tardive dyskinesia remains a challenge to identify and is often mistaken for other conditions resulting in undertreatment or inappropriate treatment, often because of confusion about the symptoms a patient is having and also around appropriate treatment options,' said Amita Patel, MD, CMD, MHA, CPE. 'These findings underscore the need to better understand and address the gaps in care that exist for residents in long-term care. Ultimately, it's imperative that residents work with their healthcare providers to seek appropriate diagnoses and learn about potential treatments for TD.' This study retrospectively analyzed a database of residents at risk for TD – those on an APD for ≥30 days and/or metoclopramide (Reglan®) for >12 weeks. Of the ~700,000 residents on an APD and ~35,000 on Reglan®, the most common underlying psychiatric diagnosis was a mood disorder (68% and 54%, respectively). These findings illustrate that a substantial portion of individuals with TD residing in LTC facilities are at risk of not receiving an appropriate diagnosis or proper standard of care, highlighting the need for more intensive evaluation of residents in LTC for TD, to improve the accuracy of diagnoses and the provision of proper treatments. Full results from the study were presented at Psych Congress Elevate on May 30, 2025, with additional data expected later this year. Use of Trademarks Reglan® is a registered trademark of UCB. About Tardive Dyskinesia (TD)Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3 About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Teva Cautionary Note Regarding Forward Looking StatementsThis Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned 'Risk Factors and 'Forward Looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. References Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258. Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. Tardive dyskinesia. National Alliance on Mental Illness website. Accessed May 4, 2023. Teva Media Inquiries:TevaCommunicationsNorthAmerica@ Investor Relations Inquires:TevaIR@ in to access your portfolio
Yahoo
11-03-2025
- Health
- Yahoo
Tennessee should curb youth vaping but avoid preventing legal access to adults
Tennessee decisionmakers are considering universal carding and other policies to curb youth vaping. Good. While e-cigarettes represent a viable alternative to traditional smoking, they are still not safe for the state's teenage population, 22% of which vape, according to the Tennessee Advisory Commission on Intergovernmental Relations (TACIR). Especially when considering that the vast majority of them smoke non-FDA approved vapes in kid-friendly flavored like candy apple and gummy bear, which are illegally imported from China. Many of these devices lack any semblance of quality control and contain harmful chemicals that pose severe risks to users. A study from Johns Hopkins University found that some of them contain toxic metals like lead and chromium, likely from poorly constructed heating coils. Tennessee has already felt the consequences of these illegal imports in a big way. In 2019, the Tennessee Department of Health reported the first death of a patient with respiratory disease from using an e-cigarette. Two weeks later, another person died from a vaping-related injury. A 30-year-old Newport, Tennessee resident disclosed that doctors informed her that she had lungs 'like an 80-year-old' from vaping. All told, in 2019, a total of 78 cases of severe lung injury related to vaping were reported to the state health department and plenty have been reported in the years since. While these Chinese, kid-friendly vapes are illegal under federal law, and all vaping remains illegal for minors, Tennessee does not have enough vetting protocols in place to keep them away from our children. Late last year, for instance, McMinn County Sheriff Joe Guy ran a sting operation that found 34 of the 47 vape stores located in the county sold illegal vaping devices or did not check the IDs of purchasers. Universal carding will solve this problem, and the state should implement it without delay. But there's another concern that could worsen the state's vaping crisis. A federal agency known as the U.S. International Trade Commission is currently attempting to ban FDA-approved vaping products in the U.S. This would not positively impact the public health. It would only drive more Tennessee smokers toward unregulated black market of Chinese vaping products or back to cigarettes, both of which carry significant health risks. As of Jan. 30, a 60-day clock began for President Donald Trump to override the ITC's recommendation. The Department of Commerce and the U.S. Trade Representative should recommend he do so because, for adult smokers trying to quit traditional cigarettes, a leading cause of preventable death in Tennessee, vaping offers a potentially safer alternative. Only three states in the nation vape more than the residents of Tennessee. For these individuals, access to regulated vaping products remains a critical tool to help them quit nicotine. Even as illicit and harmful vaping products flood the market, the U.S. Food and Drug Administration acknowledges that vaping can play a legitimate role in smoking cessation programs. The FDA has even gone so far as to approve certain vaping products to help adult smokers transition away from traditional tobacco. Ensuring that adult smokers have access to safe, effective alternatives to cheap, illegal Chinese products should be a priority, not an afterthought. Tennessee has already seen the devastating impact that illegal vaping has had on our state. Lawmakers and regulators must strike a balance − cracking down on illicit products and youth smoking while preserving access to safe, FDA-approved options. Giving China a blank check to flood the U.S. market with contraband devices would only make things worse. Tennessee Rep. Mark Green, R- Clarksville, is the chairman of the U.S. Homeland Security Committee in Congress. He, a longtime China hawk, needs to act to ensure this doesn't happen. I have every confidence that he will. And I have every confidence that Tennessee will soon pass its measures to curb youth vaping instate, too. With their strong leadership, our communities will become safer and healthier with the stroke of just a couple of pens. Monica Farrow serves as secretary and treasurer on the Tennessee Polk County Industrial Economic Development Board, is a macroeconomics adjunct professor and political science adjunct professor at Georgia Military College, and is president of Society Hill, which advises companies regarding corporate and policy issues. This article originally appeared on Nashville Tennessean: Tennessee youth use vaping products above national average | Opinion
