MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. It works by blocking a substance in the body that causes the blood vessels to tighten. The active substance in Micardis, telmisartan, is an ‘angiotensin-II-receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. [07/15/2010 - Drug Safety Communication - FDA]. The initial 40 medicines free of nitrosamine will be added to the “safe” list, the FDA says. Telmisartan, the generic version of Micardis, was approved last week by the FDA for the treatment of hypertension (high blood pressure) and reducing the risk of cardiovascular events like heart attack or stroke. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). How should I use this medication? Hydrochlorothiazide is a thiazide diuretic (water pill). 6. How does this medication work? Telmisartan is used to treat high blood pressure, heart failure, and diabetic kidney disease. Telmisartan has an accumulation index in plasma of 1.5 to 2.0 upon repeated once-daily dosing. These conditions usually require regular, daily use of medicines. What Is Micardis? The US Food and Drug Administration is warning of a shortage of a class of drugs used by millions to treat high blood pressure. Both telmisartan and olmesartan lower cholesterol levels, but compared to olmesartan, telmisartan is better at lowering LDL (“bad”) cholesterol levels. What will it do for me? In patients who suffer from hypertension, it can lower the blood pressure. On August 1, 2017, Daiichi Sankyo agreed to pay $300 million to settle all outstanding cases if at least 95% of all claimants opted in. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm, Telmisartan Advanced Consumer Information, Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch ". As a result, telmisartan relaxes the blood vessels. FDA has issued a recall of certain lots of angiotensin II receptor blocker (ARB) high blood pressure medication containing valsartan, losartan, or irbesartan. What medications are included in the current recall? All Rights Reserved. Following is a list of possible medication recalls, … TELMISARTAN: Strength(s) 40MG: Dosage form(s) TABLET: Route of administration: ORAL: Packaging size: 100: ATC code: C09CA: ATC description: ANGIOTENSIN II ANTAGONISTS, PLAIN: Reason for shortage: Disruption of the manufacture of the drug. The recommended adult dose of telmisartan is 80 mg once a day at approximately the same time each day, with or without food. Telmisartan is a white to slightly yellowish solid. Social Sharing : 146 Contraindications. [UPDATED 06/02/2011] FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs. 5. FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs. Taxotere side effects include permanent hair loss, Diabetes drug Invokana lawsuit information, Problems from Essure birth control procedure. What form(s) does this medication come in? Updated September 27, 2020 A Valsartan lawsuit is a legal claim for money damages brought by a consumer who took the high blood pressure drug and was subsequently diagnosed with cancer. Micardis (telmisartan) is an angiotensin II receptor antagonist used to treat high blood pressure (hypertension).Micardis is sometimes given together with other blood pressure medications. First, we assessed whether there was a duration-response relationship between the use of telmisartan and the incidence of cancer, both overall and according to cancer type. … The FDA Alert(s) below may be specifically about telmisartan or relate to a group or class of drugs which include telmisartan. Some brands of telmisartan come in a blister pack. [view:list_year_current_alerts=embed=alert] The Therapeutic Goods Administration is part of the Health Products Regulation Group MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Telmisartan oral tablet is a prescription medication used to treat high blood pressure. Available for Android and iOS devices. Telmisartan tablet, Zydus, 80 mg, bottle, 30 count, NDC 68382-0473-78 Estimated Resupply Dates Glenmark Pharmaceuticals has telmisartan 20 mg and 80 mg tablets on back order and the company cannot estimate a release date. Telmisartan is contraindicated during pregnancy.Like other drugs affecting the renin–angiotensin system (RAS), telmisartan can cause birth defects, stillbirths, and neonatal deaths. Distribution: Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and 1-acid glycoprotein. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. The lawsuits allege that many batches of Valsartan from 2012 to 2018 were contaminated with NDMA, a probable carcinogen. What side effects are possible with this medication? Please be advised that several Blood pressure/heart failure meds has been on REСALL for unpure carcinogen causing cancer cells in sertain organs. Recall Telmisartan Xiromed 80 mg tabletten 9 november 2020 Medical Valley Invest AB heeft in overleg met de Inspectie Gezondheidszorg en Jeugd (IGJ) besloten om Telmisartan Xiromed tablet 80 mg (ZI-nummer 16870263) met onmiddellijke ingang terug te roepen op apotheekniveau. Are there any other precautions or warnings for this medication? The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. Find out which specific blood pressure medications are affected by the recall. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Upsides: Losartan (Cozaar) was the first ARB to ever be approved, so it has the longest track record of success. Trough plasma concentrations of telmisartan with once-daily dosing are approximately 10% to 25% of peak plasma concentrations. Downsides: Telmisartan is often not the preferred ARB on insurance plans. : 146 Contraindications. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This includes some combination tablets which contain valsartan and amlodipine or valsartan, amlodipine, and hydrochlorothiazide. 4. Who should NOT take this medication? ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer. For the latest FDA MedWatch alerts, go here. Blood pressure medication recall: What you need to know The FDA continues to update the list of medications being recalled. It will take about 2 weeks for reductions in blood pressure to become noticeable and another 2 weeks until the full effects of the medication are realized. The FDA Alert(s) below may be specifically about telmisartan or relate to a group or class of drugs which include telmisartan. Telmisartan 20 MG Tablet belongs to a family of drugs that are used to treat high blood pressure.It is also effective in reducing the risk of serious conditions such a stroke, heart attacks, heart conditions and even death.Telmisartan 20 MG Tablet helps maintain optimal blood pressure levels in a person’s body.. [view:list_year_current_alerts=embed=alert] The Therapeutic Goods Administration is part of the Health Products Regulation Group By Dr. Tulsie N. Patel and Dr. Sumir Shah ; Losartan is available as a very affordable generic. The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). Dear ones! What other drugs could interact with this medication? What is telmisartan (Micardis), and what similar drugs are available? Telmisartan is a member of a family of drugs called angiotensin receptor blockers (), which includes losartan (), valsartan (), irbesartan (), and candesartan ().Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues but primarily on muscle cells of blood vessels. Recalls and safety alerts are sent out when we have important information to share—meaning you can feel more secure when choosing and using products. Changes in vision 2. dizziness, lightheadedness, or fainting 3. fast heartbeat 4. large hives 5. painful urination or changes in urinary frequency 6. swelling in the hands, lower legs, and feet Telmisartan, an ARB with partial peroxisome proliferators activated receptor-γ (PPAR-γ) agonist activity has the ability to improve glycemic and lipid status in rats fed a high fat, high carbohydrate diet. Medical uses. 2. Telmisartan is contraindicated during pregnancy.Like other drugs affecting the renin–angiotensin system (RAS), telmisartan can cause birth defects, stillbirths, and neonatal deaths. When a product is recalled, or an advisory or alert is issued, it means our surveillance tools are working. telmisartan FDA Alerts. Telmisartan tablet, Zydus, 80 mg, bottle, 30 count, NDC 68382-0473-78 Estimated Resupply Dates Glenmark Pharmaceuticals has telmisartan 20 mg and 80 mg tablets on back order and the company cannot estimate a release date. Telmisartan 40 MG Tablet belongs to a family of drugs that are used to treat high blood pressure.It is also effective in reducing the risk of serious conditions such a stroke, heart attacks, heart conditions and even death.Telmisartan 40 MG Tablet helps maintain optimal blood pressure levels in a person’s body.. For some people, it may also be used to lower the risk of heart attack, stroke, or death. If telmisartan comes in a blister pack, take out … Updated November 4, 2020 If you are a consumer or patient ... TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ) TELMISARTAN: 1 g in 1 g: Product Characteristics: ... , FDA Safety Recalls, Presence in Breast Milk. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Micardis is also used to reduce the risk of stroke, heart attack, or death from heart problems in people who are at least 55 years old with risk factors for serious heart disorders. Audience: Cardiology, Oncology, Family Practice. We performed 2 secondary analyses. So, there’s that. Losartan is made as a stand-alone drug, and in a combination tablet with the diuretic, hydrochlorothiazide (HCTZ), as losartan/HCTZ.Convenient. Telmisartan is an angiotension receptor blocker (aka ARB). Medical uses. Telmisartan tablets, USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. No statistically significant difference in cancer deaths was noted. Losartan. Date modified: 2021-01-20 Select one or more newsletters to continue. In patients who suffer from hypertension, it can lower the blood pressure. BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. This field is for validation purposes and should be left unchanged. EFFECTIVE AS OF 03/04/2020 Maintenance drugs are prescriptions commonly used to treat conditions that are considered chronic or long-term. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. But, since telmisartan is available as a generic, its cash price is affordable. The list is meant for health care professionals to review as they consider treatments. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: [06/02/2011 - Drug Safety Communication - FDA] For this analysis, telmisartan cumulative duration of use was entered as a time-dependent variable in the models. Telmisartan is used to treat high blood pressure, heart failure, and diabetic kidney disease. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. Editor’s note: This story on the recall of certain blood pressure medications has been updated numerous times since it was first published on July 24, 2018. RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. Take telmisartan at the same time of day. 1. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The recall was expanded again in April to include 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets. 3. Recalls and safety alerts are sent out when we have important information to share—meaning you can feel more secure when choosing and using products. Keep taking telmisartan as you have been told by your doctor or other health care provider, even if you feel well. The amount was later increased in May 2018 to $358 million after 97% of claimants opted in, accounting for more than 2,230 of the 2,300 cases that were part of the multidistrict litigation.. It is a reasonable initial treatment for high blood pressure. This lowers blood pressure and increases the supply of blood and oxygen to the heart. The recall for medication used to treat high blood pressure has been expanded by the FDA four times now and the number of medications falling under that recall has become daunting. The mean duration of follow-up ranged from 1.7 to 4.8 years. 1. It is a reasonable initial treatment for high blood pressure. Recall issued for 5 prescription drugs sold in Canada Four companies have announced the recall of several batches of prescription drugs on the Canadian market. FDA believes the benefits of ARBs continue to outweigh their potential risks. Want to know more? 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