{"id":632556,"date":"2025-06-16T12:03:54","date_gmt":"2025-06-16T16:03:54","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=632556"},"modified":"2025-06-16T12:03:54","modified_gmt":"2025-06-16T16:03:54","slug":"fda-approves-widaplik-for-hypertension","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-widaplik-for-hypertension\/","title":{"rendered":"FDA approves Widaplik for hypertension"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The U.S. Food and Drug Administration (FDA) has approved Widaplik, a new triple combination medication designed to treat high blood pressure in adults. Widaplik is the first single pill containing three different drugs approved as an initial treatment for hypertension. It\u2019s a huge win for people who would otherwise likely need several different prescriptions to optimize their cardiovascular health.\u00a0<\/span><\/p>\n<h2 id=\"what-is-widaplik\"><span style=\"font-weight: 400;\">What is Widaplik?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Manufactured by George Medicines, Widaplik is a combination tablet that contains three medications that work together to reduce blood pressure and lower the risk of heart attack or stroke:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/telmisartan\"><span style=\"font-weight: 400;\">Telmisartan<\/span><\/a><span style=\"font-weight: 400;\">, an angiotensin receptor blocker (ARB), treats high blood pressure<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/amlodipine-besylate\"><span style=\"font-weight: 400;\">Amlodipine<\/span><\/a><span style=\"font-weight: 400;\">, a calcium channel blocker, treats high blood pressure and angina (chest pain) caused by coronary artery disease<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/indapamide\"><span style=\"font-weight: 400;\">Indapamide<\/span><\/a><span style=\"font-weight: 400;\">, a diuretic (also known as a water pill), helps eliminate excess salt and water from the body<\/span><\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/219423s000lbl.pdf\"><span style=\"font-weight: 400;\">Widaplik<\/span><\/a><span style=\"font-weight: 400;\"> comes in one standard dose and two lower doses:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">40 mg telmisartan\/5 mg amlodipine\/2.5 mg indapamide<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">20 mg telmisartan\/2.5 mg amlodipine\/1.25 mg indapamide<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">10 mg telmisartan\/1.25 mg amlodipine\/0.625 mg indapamide<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The recommended initial therapy is one of the two lower doses once daily. However, after two weeks, your healthcare provider may increase the dose if additional blood pressure control is needed.\u00a0<\/span><\/p>\n<h2 id=\"how-does-widaplik-work\"><span style=\"font-weight: 400;\">How does Widaplik work?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The FDA\u2019s approval was based in part on the results of the two double-blind randomized trials published in <\/span><a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(24)01744-6\/abstract\"><i><span style=\"font-weight: 400;\">The Lancet<\/span><\/i><\/a><span style=\"font-weight: 400;\"> and the <\/span><a href=\"https:\/\/www.jacc.org\/doi\/abs\/10.1016\/j.jacc.2024.08.025\"><i><span style=\"font-weight: 400;\">Journal of the American College of Cardiology<\/span><\/i><\/a><span style=\"font-weight: 400;\">, which showed that Widaplik reduced systolic blood pressure by 7-8 mm Hg compared to placebo (inactive treatment) and compared to the dual therapy of its component drugs.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/blood-pressure-levels\/\"><b>Normal blood pressure levels<\/b><\/a><\/p>\n<h2 id=\"what-are-the-side-effects-of-widaplik\"><span style=\"font-weight: 400;\">What are the side effects of Widaplik?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The most common side effects of Widaplik include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Low blood sodium<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Low blood potassium<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Low blood pressure, which may cause dizziness<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/219423s000lbl.pdf\"><span style=\"font-weight: 400;\">package insert<\/span><\/a><span style=\"font-weight: 400;\"> cautions that taking non-steroidal anti-inflammatory drugs (NSAIDs) could lead to an increased risk of kidney problems and the possible loss of the medication\u2019s antihypertensive effect. The risk is higher in older adults, people with kidney problems, and people who are dehydrated.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It may also be necessary for individuals 65 years and older to start with a lower dose of this medication, due to the possibility of experiencing low blood sodium, or hyponatremia, along with low potassium levels, or hypokalemia, when taking indapamide, which is one of the three medications contained in Widaplik.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">People who are pregnant or breastfeeding should not take this medication. Also, people who have anuria, which is when you do not produce urine, should not take Widaplik. People who are allergic to any ingredient in the drug or to sulfa drugs should not take Widaplik. People with diabetes who take aliskiren should not take Widaplik.<\/span><\/p>\n<h2 id=\"who-could-a-triple-combination-hypertension-medication-help\"><span style=\"font-weight: 400;\">Who could a triple-combination hypertension medication help?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Nearly <\/span><a href=\"https:\/\/millionhearts.hhs.gov\/data-reports\/hypertension-prevalence.html\"><span style=\"font-weight: 400;\">120 million<\/span><\/a><span style=\"font-weight: 400;\"> people in the U.S. (almost half of all adults) have hypertension, but only about 1 in 4 adults actually have their hypertension under control.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">While everyone diagnosed with hypertension is advised to make lifestyle changes to help them lower their blood pressure, most adults need to take a prescription medication to meet their goals.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Currently, the available <\/span><a href=\"https:\/\/www.heart.org\/en\/health-topics\/high-blood-pressure\/changes-you-can-make-to-manage-high-blood-pressure\/types-of-blood-pressure-medications\"><span style=\"font-weight: 400;\">classes of medications to help treat high blood pressure<\/span><\/a><span style=\"font-weight: 400;\"> include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">ACE inhibitors<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Alpha blockers<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Alpha-2 receptor agonists<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Angiotensin II receptor blockers (ARBs)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Beta-blockers<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Calcium channel blockers<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Diuretics<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vasodilators<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Many people have to eventually increase the dosage of their current medication to achieve blood pressure control. It\u2019s also not uncommon for some people to need more than one medication to help them manage their high blood pressure.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cSingle pill combination antihypertensive therapy has great potential to improve hypertension control in the U.S. and worldwide,\u201d said Dr. Paul Whelton, MD, chair of global public health at Tulane University and the past president of the World Hypertension League, in the <\/span><a href=\"https:\/\/george-medicines.com\/george-medicines-announces-fda-approval-of-widaplik-telmisartan-amlodipine-and-indapamide-a-new-single-pill-combination-treatment-for-hypertension-in-adults-including-initial-treatment\/\"><span style=\"font-weight: 400;\">manufacturer\u2019s statement<\/span><\/a><span style=\"font-weight: 400;\">. \u201cMost patients with hypertension need multiple therapies to achieve their blood pressure goals. The new dose options available with Widaplik offer a treatment regimen that could benefit a broad range of patients, including those just starting treatment.\u201d<\/span><\/p>\n<h2 id=\"how-much-will-widaplik-cost\"><span style=\"font-weight: 400;\">How much will Widaplik cost?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">George Medicines has not yet announced pricing for Widaplik.<\/span><\/p>\n<h2 id=\"when-will-widaplik-be-available\"><span style=\"font-weight: 400;\">When will Widaplik be available?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Widaplik should be commercially available during the fourth quarter of 2025.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has approved Widaplik, a new triple combination medication designed to treat high blood pressure in adults. Widaplik is the first single pill containing three different drugs approved as an initial treatment for hypertension. It\u2019s a huge win for people who would otherwise likely need several different prescriptions to [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":632557,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[4141,737,20951],"coauthors":[9482],"class_list":["post-632556","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approvals","tag-heart-health","tag-high-blood-pressure","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves Widaplik for hypertension<\/title>\n<meta name=\"description\" content=\"The FDA has approved Widaplik (telmisartan, amlodipine, and indapamide), a single-pill combination treatment for hypertension.\" \/>\n<meta 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