Hydrochlorothiazide/Olmesartan Medoxomil

精彩内容 第十一批国采将于10月21日开标，6个心脑血管系统药物在列，11亿大品种领跑。米内网数据显示，近年来中国公立医疗机构终端心脑血管系统化药市场承压，2023年至今已“三连跌”。在2025年上半年TOP20集团中，信立泰、扬子江、新和成首次登榜；销售额TOP20品牌中原研药霸榜，“一哥”易主，独家品种大涨128.6%；销售量TOP20品牌中国采中标品种霸榜，京新药业、南京正大天晴等有多个品牌上榜。 市场3连跌！信立泰、扬子江首次登榜 近年来，随着国家集采及省级集采的持续推进，心脑血管系统化药在医疗机构的市场格局发生着巨大变化。 米内网数据显示，2024年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端心脑血管系统化药销售规模跌破千亿后，2025年上半年以约8%的幅度继续下跌，2023年至今已“三连跌”，且下跌幅度呈逐年递增态势。 近年来中国公立医疗机构终端心脑血管系统化药销售情况（单位：万元） 来源：米内网中国公立医疗机构药品终端竞争格局 从治疗亚类看，心脑血管系统化药以高血压用药为主，2025年上半年占比超过50%；心脏病治疗用药以约18%的占比紧接其后，销售额同比下滑接近23%；血脂调节剂有“回暖”迹象，以约18%的占比排位第三；排位第四的脑血管治疗用药“承压”，销售额同比下滑超过30%。 在已落地执行的九批十轮化药集采中，共有63个心脑血管系统药物（不含落标品种）被纳入，其中高血压用药首当其冲，占比超过58%。 随着国家集采的常态化推进，已纳入国采的心脑血管系统化药销售额下滑明显，由2019年超810亿元下滑至2024年的约540亿元，预计2025年或跌破500亿元，占比上基本与非国采品种“平分秋色”。 近年来中国公立医疗机构终端心脑血管系统化药国采品种与非国采品种销售额占比 来源：米内网中国公立医疗机构药品终端竞争格局 在一级集团TOP20中，晖致、诺华、阿斯利康稳居前三，2025年上半年销售额分别超过35亿元、31亿元、18亿元；与2024年相比，浙江海正药业、欧加农制药均提升7个位次，正大制药提升4个位次，信立泰、扬子江药业、新和成首次登榜。 2025H1中国公立医疗机构终端心脑血管系统化药TOP20集团 注：标红为销售额增速达两位数 来源：米内网中国公立医疗机构药品终端竞争格局 2025年上半年，信立泰、扬子江药业、新和成分别有6个、19个、18个心脑血管系统化药在销。其中，信立泰的国产1类创新药阿利沙坦酯片销售额超过5亿元，同比增长超过17%；扬子江药业的苯磺酸左氨氯地平片、氨氯地平贝那普利片(Ⅰ)销售额均超过2亿元，注射用尼可地尔、盐酸法舒地尔注射液、奥美沙坦酯氨氯地平片等同比增长均超300%；新和成的奥美沙坦酯片、替米沙坦片、依折麦布片均销售过亿，奥美沙坦酯氢氯噻嗪片同比增长超300%等。 “一哥”易主！独家品种大涨128.6% 从销售额排名看，2025年上半年心脑血管系统化药TOP20品牌中，诺华的沙库巴曲缬沙坦钠片、晖致的阿托伐他汀钙片、阿斯利康的瑞舒伐他汀钙片依次位列前三，销售额均超过10亿元，其中诺华的沙库巴曲缬沙坦钠片首次“称王”；拜耳的硝苯地平控释片、晖致的苯磺酸氨氯地平片位列第四、第五，销售额均超过9亿元。 2025H1中国公立医疗机构终端心脑血管系统化药销售额TOP20品牌 注：标*为增速低于5% 来源：米内网中国公立医疗机构药品终端竞争格局 20个品牌中有13个为进口品牌，其中有12个为原研药（含原研地产化），7个已被纳入国家集采；国产品牌中，4个为国采品种，1个为国产1类新药等；从企业层面上看，诺华、晖致、阿斯利康、拜耳均有2个品种上榜，悦康药业、信立泰、南京正大天晴、齐鲁制药等国内企业亦有品种上榜。 13个品牌销售额实现正增长，其中有7个涨逾10%，拜耳的独家品种非奈利酮片暴涨128.63%、辉瑞的甲磺酸多沙唑嗪缓释片大涨23.88%；受第十批国采执行影响，远大医药(中国)的重酒石酸去甲肾上腺素注射液、齐鲁制药的盐酸艾司洛尔注射液分别大跌56.15%、39.77%。 从销售量排名看，2025年上半年心脑血管系统化药TOP20品牌中，齐鲁制药及乐普制药的阿托伐他汀钙片、浙江京新药业的苯磺酸氨氯地平片依次位列前三，销售量均超过10亿片；浙江华海药业的厄贝沙坦片以超9亿片的销售量排位第四，卫材的甲磺酸倍他司汀片以超8亿片的销售量排位第五。 2025H1中国公立医疗机构终端心脑血管系统化药销售量TOP20品牌 注：标*为增速低于5% 来源：米内网中国公立医疗机构药品终端竞争格局 国采中标品种霸榜，20个品牌中有15个为国采中标品种，4个为进口原研药（2个未纳入国采），1个为非国采国产品种；从企业层面上看，浙江京新药业、南京正大天晴制药、东瑞制药均有2个品种上榜。 从销售量增长情况看，8个品牌涨逾10%，其中重庆药友制药的苯磺酸氨氯地平片暴涨111.33%、福建东瑞制药的阿托伐他汀钙片大涨42.08%、浙江京新药业的苯磺酸氨氯地平片大涨31.84%等。 11亿明星药承压！6大品种迎战第十一批国采 截至9月19日，190个心脑血管系统化药已有企业过评或视同过评。21个品种遭“哄抢”，过评企业数达20家及以上，其中苯磺酸氨氯地平片以64家企业领跑，己酮可可碱注射液、盐酸多巴胺注射液、盐酸乌拉地尔注射液、缬沙坦氨氯地平片(Ⅰ)、瑞舒伐他汀钙片、注射用尼可地尔、阿托伐他汀钙片、盐酸多巴酚丁胺注射液均达30家以上。 从企业过评情况看，上海医药、石家庄四药、华海药业、福元医药、远大健康、倍特药业、复星医药、华润医药、鲁南制药等药企（以集团计）已过评品种数均达20个及以上，其中上海医药以35个品种领跑，石家庄四药以31个品种紧接其后。 近日，第十一批国采标书正式出炉，将于10月21日开标。6个为心脑血管系统药物在列，包括3个心脏病治疗用药、1个血脂调节剂、1个高血压用药、1个脑血管治疗用药。 纳入第十一批国采的心脑血管疾病药物 来源：米内网综合数据库 从市场规模看，6个药品2024年在中国公立医疗机构终端的销售额合计超过36亿元，其中普伐他汀口服常释剂型以超11亿元领跑，尼可地尔口服常释剂型、贝尼地平口服常释剂型销售额均超过7亿元。 从竞争情况看，5个品种符合申报资格企业数超过10家，其中尼可地尔口服常释剂型、去氧肾上腺素注射剂（1ml:10mg）、贝尼地平口服常释剂型均达15家及以上。 从过评企业看，石家庄四药以4个过评品种领跑，北京福元医药以3个过评品种紧接其后，百诚医药、倍特药业、成都瑞尔医药、浙江诺得药业、远大健康等8家企业均有2个过评品种在列。 此外，4个心脑血管系统药物满足充分竞争条件但未纳入第十一批国采，其中有2个因各省医药集中采购平台统计的2024年采购金额小于1亿元而被排除；1个因存在专利侵权高风险而被排除，1个品种因“跨医保目录”品种区分医保性质，各品规均不满足充分竞争格局而被排除。 满足条件但未纳入第十一批国采的心脑血管系统药 注：销售额低于1亿元用*代替 4个药品中，沙库巴曲缬沙坦口服常释剂型2024年在中国公立医疗机构终端的销售额超过38亿元，其中原研厂家主导市场，占比超过98%，该药目前符合申报资格企业数已达28家。 资料来源：米内网数据库、上海阳光医药采购网等 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至9月19日，如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

CLOZARIL (clozapine) NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records Descriptive study In FDA’s review of the effectiveness of the clozapine REMS, FDA conducted several analyses of clozapine registry patients, describing adherence to absolute neutrophil count monitoring, as specified by the clozapine REMS, and estimating the cumulative risk of severe neutropenia. The study results were included in the November 19 Joint Meeting of the Drug Safety and Risk Management and Psychopharmacologic Drugs Advisory Committee briefing package, where the committee voted to remove the clozapine REMS. Based on the advice from the Advisory Committee and the Agency’s re-evaluation, the Agency removed the clozapine REMS and issued a DSC. DSC August 27,2025 FDA Drug Safety Communication: FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine (REMS release, labeling changes) Toprol-XL and Lopressor (Metoprolol), Inderal LA (propranolol), [beta blockers] Multiple NDAs Multiple sponsors Sentinel System Retrospective cohort study The results from a retrospective cohort study in Sentinel indicated an association between beta blocker use and hypoglycemia in pediatric populations. FDA approved safety labeling changes to describe the risk for hypoglycemia in pediatrics or individuals unable to communicate signs of hypoglycemia. This resulted in a labeling change. Beta Blockers Safety Communications & Labeling Changes (Sentinel Initiative), July. 25, 2025. FDA Labeling Change: Additional Language to Mitigate the Risk of Hypoglycemia Associated with Beta Blockers in Children Beta blockers | Sentinel Initiative Entyvio (vedolizumab) BLA 761359 Takeda Pharmaceuticals Sentinel System Descriptive study The results from a descriptive Sentinel study did not indicate an increased risk for Interstitial lung disease (ILD) in patients treated with vedolizumab or natalizumab for inflammatory bowel disease. However, there were other data from case reports from the medical literature and FDA FAERS. This resulted in FDA adding “interstitial lung disease, pneumonitis” to the Postmarketing Experience subsection of labeling. Entyvio Safety Communications & Labeling Changes (Sentinel Initiative), April 18, 2024. FDA Labeling Change: Vedolizumab & Interstitial Lung Disease (ILD) Prolia (Denosumab) BLA 125320 Amgen Medicare claims data Retrospective cohort study In FDA’s review of denosumab, an FDA retrospective cohort study in Medicare found an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking this medication. This resulted in a DSC and addition of a Boxed Warning for an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. FDA added a boxed warning. DSC, January 19, 2024 (severe hypocalcemia). FDA Drug Safety Communication: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) Prolia label change, November 22, 2022. FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia Anticoagulant, oral Multiple NDAs Multiple sponsors Sentinel System Retrospective cohort study FDA conducted a retrospective cohort study in the Sentinel System to examine severe uterine bleeding events requiring medical intervention in women treated with oral anticoagulants. The study found a risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions. This finding contributed to a class-wide label change for this risk with oral anticoagulants and that this should be assessed in females of reproductive potential and those with abnormal uterine bleeding. There was also a communication via the Sentinel initiative website. Oral Anticoagulants Safety Communications & Labeling Changes (Sentinel Initiative), January. 28, 2021. FDA Labeling Change: Oral Anticoagulants and Clinically Significant Uterine Bleeding Methotrexate, oral Multiple NDAs Multiple sponsors Sentinel System A chart confirmed analysis was conducted in one Sentinel Data Partner An FDA medical chart review analysis conducted in a Sentinel Data Partner, found the incidence of low-dose oral methotrexate wrong frequency dosing errors to be 0.4%. This resulted in adding the risk of improper dosing to Section 5 (Warnings and Precautions), removing an option for doses given every 12 hours for 3 days each week from Section 2 (Dosage and Administration). Oral Methotrexate (Sentinel Initiative), December. 17, 2021. FDA Labeling Change: Oral Methotrexate and Wrong Frequency Dosing Errors Singulair (montelukast) NDA 021409 Organon Sentinel System Retrospective cohort study Retrospective cohort studies conducted in the Sentinel system informed the re-evaluation of the benefits and risks of montelukast use. Considering the totality of evidence, including the negative Sentinel studies resulted in FDA strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics). There was also a communication via the Sentinel initiative website. Singulair Safety Communications & Labeling Changes (Sentinel Initiative), March. 3, 2020. FDA Requires Boxed Warning about Serious Mental Health Side Effects for Asthma and Allergy Drug Montelukast (Singulair); Advises Restricting Use for Allergic Rhinitis Hydrochlorothiazide (HCTZ)-containing products Multiple NDAs Multiple sponsors Sentinel System Retrospective cohort study An FDA conducted retrospective cohort study in the Sentinel System assessed the risk of non-melanoma skin cancer for patients treated with HCTZ-containing products. The study identified an association with an increased risk of non-melanoma skin cancer, predominantly for squamous cell carcinoma and in white patients taking large cumulative doses. These findings informed additions to adverse reactions and patient information sections of the labeling, and a communication via the Sentinel initiative website. HCTZ Safety Communications & Labeling Changes (Sentinel Initiative), August. 20, 2020. FDA Labeling Change: Hydrochlorothiazide and Non-Melanoma Skin Cancer Feraheme, infed, injectafer, monoferric, venofer (Parenteral Iron Products) Multiple NDAs Multiple sponsors Sentinel System Descriptive study An FDA Sentinel analysis characterized the frequency of IV iron utilization relative to live birth and stillbirth deliveries. The finding contributed to a class-wide labeling update for parenteral iron products to add new safety information to Section 8 (Use in Specific Populations, Pregnancy) of the label. This update describes the risk of severe adverse reactions to pregnant women and their fetus. There was also a communication via the Sentinel initiative website. Parenteral Iron Safety Communications & Labeling Changes (Sentinel Initiative) The class-wide labeling update regarding risks to pregnant women and their fetus was approved on September. 11, 2020. FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses Comtan, Stalevo (Entacapone) NDA 021485/ 20796 Orion Corporation VHA claims, medical records, and cancer registry Retrospective cohort study In FDA’s review of entacapone, an FDA conducted retrospective cohort study in the VA found no clear evidence of an increased risk of prostate cancer in patients treated with entacapone versus add-on dopamine agonist or monoamine oxidase inhibitor. This resulted in a DSC. Entacapone DSC, August 13, 2019 (no increase in prostate cancer risk). FDA Drug Safety Communication: FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) Pradaxa (dabigatran) NDA 022512 Boehringer Ingelheim Pharmaceuticals, Inc Medicare claims data Retrospective cohort study In FDA’s review of dabigatran, an FDA conducted retrospective cohort study among Medicare patients, showed lower risks stroke and death but higher risk for gastrointestinal bleeding with PRADAXA compared to warfarin. FDA still considered Pradaxa to have a favorable benefit/risk profile and made no changes to the labeling. This resulted in a DSC. Dabigatran Drug Safety Communication, May 13, 2014 FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin Enbrel (etanercept) BLA 103795 Amgen Inc. Sentinel System Descriptive study FDA conducted a drug utilization analysis of TNF alpha inhibitors in pregnant women in the Sentinel System. The study found that among pregnant women with a chronic inflammatory condition, there was a preference to use etanercept compared to other TNF alpha inhibitors. This assessment was one source of evidence considered for the Pregnancy and Lactation Labeling Rule (PLLR) Conversion Safety Labeling Change. There was also a communication via the Sentinel initiative website. ENBREL Safety Communications & Labeling Changes (Sentinel Initiative), July. 11, 2017. FDA Labeling Change: Etanercept (Enbrel) and Use in Pregnancy Gadolinium-based contrast agents (GBCA) Multiple NDAs Multiple sponsors Sentinel System Descriptive study Analyses on gadolinium retention were done with FDA Sentinel data and other data streams. These analyses, in part, resulted in class-wide updates to Section 5 (Warnings and Precautions) to include the risk of gadolinium retention in tissues, including the brain, for months to years, a medication guide, required manufacturers to conduct additional safety assessments. There was also a communication via the Sentinel initiative website. GBCAs Safety Communications & Labeling Changes (Sentinel Initiative), December. 19, 2017. FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings Comtan, Stalevo (entacapone) NDA 021485/ 20796 Orion Corporation Medicare claims data Retrospective cohort study FDA conducted a retrospective cohort study in Medicare to assess cardiovascular risk associated with entacapone use. FDA found no clear evidence of increased cardiovascular risk with entacapone. The study resulted in a publication and DSC. Entacapone DSC, October 26, 2015. FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone Movement Disorder Society Publication, 2013 . Benicar (olmesartan) NDA 021286 Daiichi Sankyo Medicare claims data Retrospective cohort study In FDA’s review of Olmesartan, an FDA conducted retrospective cohort study in Medicare found no clear evidence of increased cardiovascular risks associated with high dose use in diabetic patients. As a result, FDA’s recommendations for use of olmesartan (BENICAR, BENICAR HCT, AZOR, TRIBENZOR, and generics) in patients with diabetes remained the same. This resulted in a DSC and the addition of the study information in the labeling. Olmesartan DSC, June 24, 2014 (Medicare study results added to labeling). FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required Benicar, Benicar hct (Olmesartan), Azor, Tribenzor (medoxomil) Multiple NDAs Daiichi Sankyo Inc. Mini-Sentinel and Medicare Retrospective cohort study In FDA’s review of Olmesartan, an FDA evaluation of the FDA Adverse Event Reporting System (FAERS) and the published literature found evidence of an association between olmesartan and sprue-like enteropathy. To evaluate an ARB class association FDA conducted a retrospective cohort study in Mini-Sentinel and Medicare. These study results did not support a class effect. This resulted in an FDA safety communication that Olmesartan-containing products can cause intestinal problems known as sprue-like enteropathy. Olmesartan Safety Communications & Labeling Changes (Sentinel Initiative), July. 3, 2013. FDA Approves Labeling Changes to Include Intestinal Problems (Sprue-Like Enteropathy) Linked to Blood Pressure Medicine Olmesartan Medoxomil Pradaxa (dabigatran) NDA 022512 Boehringer Ingelheim Pharmaceuticals, Inc Mini-Sentinel Retrospective cohort study In 2012, an FDA conducted retrospective cohort study in Mini-Sentinel evaluated new information about the risk of serious bleeding associated with use of dabigatran (PRADAXA) and warfarin (COUMADIN, JANTOVEN, and generics). The results indicated that bleeding rates associated with new use of Pradaxa did not appear to be higher than bleeding rates associated with new use of warfarin, which was consistent with observations from the large clinical trial used to approve Pradaxa. FDA issued a DSC to communicate the findings and a communication via the Sentinel initiative website. DSC November, 02,2012 FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran) Sentinel Initiative, October. 31, 2012. Update on the Risk for Serious Bleeding Events with the Anticoagulant Pradaxa (Dabigatran) Epogen, Procrit, Aranesp (Erythropoietin stimulating agents (ESA)) BLA 103234 and BLA 103951 Amgen Medicare claims data Retrospective cohort study In FDA’s review of the effects of a labeling change recommending lower doses of ESAs in dialysis patients, an FDA retrospective cohort study in Medicare which assessed the effects of the changes in reimbursement policy in addition to changes in the ESA’s drug labeling found that the risk of MACE and mortality was unchanged, and risk of stroke was reduced following the labeling change. In Black patients, there was a substantial reduction in MACE and mortality after the labeling change. A bundled comprehensive payment system for dialysis that includes the costs of ESAs, and a revised drug label that recommends more conservative dosing had no adverse effects on older dialysis patients covered by fee-for-service Medicare. This resulted in a publication. The labeling change regarding use in patients with chronic kidney disease (CKD) was approved on June 24,2011 JAMA Publication, 2016. Avandia (rosiglitazone) NDA 021071 GlaxoSmithKline Medicare claims data Retrospective cohort study FDA conducted a retrospective cohort study in Medicare that evaluated the risk of heart attacks in patients taking rosiglitazone. The study resulted in labeling changes and an update to the Risk Evaluation and Mitigation Strategy (REMS) to include a restricted access and distribution program for all three rosiglitazone products. This also resulted in two Drug Safety Communications (DSC). Rosiglitazone DSC, May 18, 2011 (imposition of REMS for rosiglitazone use). FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl Rosiglitazone DSC and labeling change, February 3, 2011 (Medicare results added to label). FDA Drug Safety Communication: Avandia (rosiglitazone) labeling now contains updated information about cardiovascular risks and use in certain patients Imitrex (sumatriptan), Treximet® (sumatriptan and naproxen sodium) NDA 020626/ 020080/ 020132/ 021926/ GSK Pregnancy registry Prospective registry study The Sumatriptan/Naratriptan/Treximet Pregnancy Registry collected data on fetal malformations and birth defects from in-utero exposure to sumatriptan (January 1996 to September 2012). A prospective study conducted by the Sponsor identified too few exposed pregnancy outcomes to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Section 8 of the label was updated to reflect that data from the prospective pregnancy exposure registry and other epidemiological studies of pregnant women did not show an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population. Completed Pregnancy Registry Study (ClinicalTrials.gov ID NCT01059604) Sumatriptan and Naratriptan Pregnancy Registry Study IMITREX labeling update December 14, 2017: See Section: 8 USE IN SPECIFIC POPULATIONS, 8.1 Pregnancy TREXIMET labeling update April 28,2021: TREXIMET labeling update April 28, 2021: See Section: 8 USE INSPECIFIC POPULATIONS, 8.1 Pregnancy Amerge (naratriptan) NDA 020763 GSK Pregnancy registry Prospective registry study The Sumatriptan/Naratriptan/Treximet Pregnancy Registry collected data on adverse fetal outcomes from in utero exposure to naratriptan. Section 8 of the AMERGE labeling was updated to reflect that no definitive conclusions could be drawn from the registry and epidemiological studies regarding the risk of birth defects following exposure to naratriptan. AMERGE label update November 29, 2016 See Section: 8 USE IN SPECIFIC POPULATIONS, 8.1 Pregnancy Proton pump inhibitors (PPI) Multiple NDAs Multiple sponsors Medicare claims data Case-control study In FDA’s review of drugs repurposed for treating patients with COVID-19 or drugs being taken by patients with COVID-19, there was concern that PPI use might increase the risk of developing severe COVID-19. An FDA conducted case control study in Medicare compared new users of PPIs versus new users of histamine-2 receptor antagonists and found that PPIs were not associated with increased risk uncomplicated or complicated (ICU, mechanical ventilation, death) COVID-19 hospitalizations. This provided reassurance to FDA that regulatory action was not needed. This resulted in a publication. Pharmacotherapy publication, 2024 . Angiotensin-converting enzyme (ACE) Inhibitors (multiple) and angiotensin receptor blockers (ARB) (multiple) Multiple NDAs Multiple sponsors Medicare claims data Case-control study In FDA’s review of ACE inhibitors or ARBs, an FDA conducted case-control study in Medicare evaluated the effect of ACE inhibitors or ARBs on the risk of developing severe COVID-19 and found that use of these drugs was not associated with increased risk of hospitalized COVID-19 or COVID-19-related mortality. No labeling changes were warranted. This resulted in a publication. Journal of General Internal Medicine publication, 2021. EPOGEN, PROCRIT, ARANESP (Erythropoietin stimulating agents (ESA)) BLA 103234 and 103951 Amgen Medicare Retrospective cohort study FDA reviewed the effect of the REMS for ESA use for chemotherapy-induced anemia, during and after the discontinuation of the REMS, and conducted a restrospective cohort study in Medicare that showed that the REMS had minimal impact on ESA use or transfusion rates and that the removal of the REMS did not affect subsequent ESA use or blood transfusions. Study results provided reassurance that FDA's removal of the REMS had not led to increased ESA use or transfusions. This resulted in a publication. Pharmacoepidemiology Drug Safety publication, 2021 . LYBREL (ethinyl estradiol; levonorgestrel) NDA 021864 Pfizer Sentinel System Retrospective cohort study An FDA conducted retrospective cohort study evaluated the risk of venous thromboembolism (VTE) for extended cycle contraceptives to determine whether these posed a greater risk of VTE due to increased hormone exposure, compared to 28-day products. The study provided reassurance that VTE risk was not substantially different between traditional and extended use oral contraceptives. JAMA Publication 2018 Januvia (sitagliptin) NDA 021995 Merck Pregnancy registry Prospective registry study A prospective study conducted by the Sponsor in a pregnancy registry identified too few exposed pregnancy outcomes to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Section 8 of the labeling was updated to reflect that the data available for pregnant women exposed to sitagliptin were not sufficient to inform a drug- associated risk for major birth defects and miscarriage. JANUVIA label update February 9, 2018. See Section: 8 USE IN SPECIFIC POPULATIONS, 8.1 Pregnancy - Risk Summary 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.