Empagliflozin

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Cleveland Clinic-led study finds Twin Health's precision AI and hyper-personalized care outperforms standard diabetes treatment—reducing A1C, unhealthy weight, and medication use MOUNTAIN VIEW, Calif., Aug. 20, 2025 /PRNewswire/ -- Today, Twin Health announced the publication of results from a Cleveland Clinic-led study in the New England Journal of Medicine Catalyst, evaluating its Twin Precision Treatment for the management of type 2 diabetes. The program features technology-driven interventions that leverage artificial intelligence to deliver personalized insights and lifestyle recommendations aimed at improving glycemic control and metabolic health in adults with type 2 diabetes. The findings, published today, showed that 71% of study participants using the Twin Precision Treatment system met the primary endpoint of achieving an A1C below 6.5% while eliminating most blood sugar-lowering medications, including glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose cotransporter-2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, and insulin. Continue Reading 71% of study participants in the Twin Health group lowered A1C below 6.5% without high-cost glucose-lowering medications. Type 2 diabetes affects nearly 1 in 10 Americans, and prolonged elevated blood sugar levels increase the risk of serious complications like heart disease, kidney failure, and stroke. Twin Precision Treatment System Uses Artificial Intelligence, Machine Learning and Wearable Sensors for Sustainable Results Developed by Twin Health, the Twin Precision Treatment combines digital twin AI with personalized clinical care, including licensed providers, nurses, and coaches. Using data from wearable sensors, the system continuously tracks real-time health metrics such as blood glucose levels, weight, blood pressure, stress, physical activity, and sleep. Users access these insights through a smartphone app, offering personalized nutrition and exercise guidance, encouraging patients to achieve their goals and sustainable health improvements. The specific app-generated dietary recommendations were based on AI-enabled predictions of each patient's blood glucose responses to specific meals. "The study demonstrates that AI-driven precision medicine is the key to metabolic healing," said Dr. Lisa Shah, chief medical officer and executive vice president of Twin Health. "We're committed to our mission of producing real results for real people. This study is an important milestone on that journey and a glimpse into what's ahead for the future of metabolic care." Kevin M. Pantalone, D.O., Director of Diabetes Initiatives at the Cleveland Clinic and a professor of medicine at the Cleveland Clinic Lerner College of Medicine, served as the primary investigator for this study. For the clinical trial (NCT05181449), researchers aimed to determine whether Twin Health's Twin Precision Treatment system could help individuals with type 2 diabetes, managed in a primary care setting, achieve their blood sugar goals while also eliminating glucose-lowering medications. "In routine clinical practice, type 2 diabetes is often treated with a one-size-fits-all approach where individuals are prescribed medications and told to 'watch their diet and stay active," said Dr. Pantalone. "Our study demonstrated the AI-enabled system of sensors to understand each patient's unique metabolic profile, and AI-enabled human care team coaching facilitated significant improvements in glycemic control, weight loss, and quality of life versus usual care, while allowing marked de-escalation of glucose-lowering medications. Interventions like this system can help patients make informed, lasting lifestyle changes to control their blood sugar and sustain weight loss." Dr. Pantalone collaborated with a team of 13 primary care physicians to recruit 150 patients from the Cleveland Clinic Twinsburg Family Health Center located in Twinsburg, Ohio. Of these, 100 were assigned to the Twin Precision Treatment group and 50 to the standard of care group. On average, patients were 58.5 years old, had been living with type 2 diabetes for about nine years, and presented with a mean body mass index (BMI) of 35.1 and an average A1C level of 7.2%. The primary endpoint was to see how many participants reached an A1C below 6.5% after 12 months without needing any glucose-lowering medications except for metformin, a common low-cost diabetes medication. After one year, a majority of study participants in the Twin intervention group achieved an A1C below 6.5% After one year, 71% of participants enrolled in the intervention group lowered their A1C levels below the 6.5% threshold, while taking only metformin. By comparison, only 2.4% of participants receiving standard care achieved the same result. Participants in the Twin intervention group also lost more weight (8.6% vs 4.6% of body weight) while significantly reducing their reliance on medications: GLP-1 Receptor Agonist medication use decreased from 41% to 6% among participants SGLT-2 Inhibitor use decreased from 27% to 1% of participants Dipeptidyl peptidase-4 (DPP-4) inhibitor use decreased from 33% to 3% in participants Insulin use decreased from 24% to 13% among participants The quality of life scores and treatment satisfaction were notably better for those using the Twin Precision Treatment, highlighting its potential as a highly effective and sustainable option for diabetes management. Real-World Reduction in GLP-1 Use In the Cleveland Clinic-led study, 85% of participants in the Twin Health program eliminated GLP-1s, demonstrating that many individuals can sustain clinical goals without long-term dependence. Translating Clinical Success into Cost Savings Twin Health is proven effective for diabetes, weight loss and metabolic health comorbidities, including hypertension. Twin Health's real-world results echo the RCT findings, delivering over $8,000 in average first-year savings per member. These savings result from reducing reliance on high-cost medications, such as GLP-1s, and avoiding unnecessary care utilization, making Twin a scalable and cost-effective solution for employers and health plans seeking to address the growing burden of metabolic disease. About Twin Health Twin Health's AI digital twin technology creates a real-time model of each individual's unique metabolism using data from smart devices, lab results, and meal logs. This model provides personalized guidance on nutrition, activity, sleep, and more, supported by a compassionate clinical team. Twin's AI digital twin and human care work in synergy, providing a continuous new standard of care for metabolic health. For employers and health plans, Twin delivers $8.0K+ in annualized savings per member by safely reducing reliance on high-cost medications and lowering avoidable medical utilization. Twin's clinical results for diabetes, weight loss and metabolic health co-morbidities, including hypertension, are peer-reviewed and published in top journals, including the New England Journal of Medicine Catalyst and those of the American Heart Association, American Diabetes Association, and American College of Cardiology. Learn more at . Press Contact Alex McKechnie AOX3 for Twin Health [email protected] 475.399.4056 SOURCE Twin Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED