RECOMMENDATION: Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. Since it came on the market Benicar has been found to increase the risk of serious gastrointestinal conditions in some of the patients using it. Benicar (olmesartan medoxomil) is a popular blood pressure medication sold by Daiichi Sankyo, Inc. 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. 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. This lowers blood pressure and increases the supply of blood and oxygen to the heart. It has been linked to a rare and severe gastrointestinal disorder called sprue-like enteropathy. The pharmaceutical company has not received any reports of adverse events related to this recall and believes that the cancer risk posed by the contaminated pills is low. Recommendations for use of olmesartan remain the same, but FDA will require information about some of the studies to be included in the drug labels. BENICAR (olmesartan medoxomil) 5mg, 20mg, 40mg tablets by Daiichi Sankyo The FDA is warning that the antihypertensive Olmesartan Medoxomil can cause intestinal problems known as … Olmesartan is an angiotensin II receptor blocker (ARB). ROADMAP and ORIENT are both long-term clinical trials. BACKGROUND: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. Losartan is a prescription medication used to treat high blood pressure and congestive heart failure. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. ISSUE: FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. So, we’re now choosing between losartan, olmesartan, and telmisartan. In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan, used to treat high blood pressure and heart failure, because of contamination with an impurity, the potentially cancer-causing chemical N-nitrosodimethylamine, or NDMA. In February, the House Energy and Commerce Committee wrote to former commissioner FDA Scott Gottlieb to inquire about inspections at overseas drug packaging plants. FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks. This medicine is available only with your doctor's prescription. The FDA advises patients who take these drugs — even the ones that have been recalled — to continue taking them but to talk to their doctor or pharmacist immediately about alternative treatment. The pills come in 100-count blister packs with NDC number 60687-139-01. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. For the latest FDA MedWatch alerts, go here. FDA has approved changes to the labels of these drugs to include this concern. Saiontz & Kirk, P.A. The FDA said on Friday that the recall affected products on shelves at selected retailers with best-by dates ranging from Aug. 4, 2020 to Aug. 17, 2020. Other drugs affected by the valsartan recall include losartan and irbesartan. This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The latest is American Health Packaging's 160 mg valsartan tablets, lot number 179791 that expire on March 31, 2020. Lawsuits related to Benicar and other olmesartan drug products created by Daiichi Sankyo were centralized into a multidistrict litigation (MDL) case in the United States District Court for the District of New Jersey. [06/02/2011 - Drug Safety Communication - FDA] Benicar is the brand name for the generic drug olmesartan medoxomil. BACKGROUND: FDA safety review was prompted by the results of the ROADMAP trial. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Another pharmaceutical company is recalling blood pressure medication after detecting trace … Another 3.6 million prescriptions were written for irbesartan that year. “While we’ve concluded through our risk assessments that the maximum possible exposure to nitrosamines in ARB medicines appears to be small, their presence in drug products is not acceptable.”. No statistically significant difference in cancer deaths was noted. The FDA says losartan isn't currently in shortage but acknowledged that other blood pressure medications are and that more recalls may soon lead to shortages. The alarming number of recalls has gained the attention of the federal government. IE 11 is not supported. SANDOZ OLMESARTAN: Common or Proper name: OLMESARTAN: Company Name: SANDOZ CANADA INCORPORATED: Market Status: MARKETED: Active Ingredient(s) OLMESARTAN MEDOXOMIL: Strength(s) 40MG: ... 2020-08-07: Actual end date: 2020-08-03: Shortage status: Resolved: Updated date: 2020-08-24: Company comments: Health Canada comments: 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. By Shamard Charles, M.D. The disorder can be life-threatening. FDA expands recall on blood pressure drug 02:42. Benicar was developed and first manufactured by the Japanese company called Daiichi Sankyo. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. It is often misdiagnosed as Celiac disease because it has similar symptoms including chronic diarrhea. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. In Re: Benicar (Olmesartan) Products Liability Litigation, MDL No. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA The FDA has taken a proactive approach in addressing how manufacturers should ensure safety of their products by urging manufacturers to be vigilant in their assessment of the supplies used to make the popular drugs, to ensure that they are nitrosamine-free. BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. Olmetec - olmesartan medoxomil sold in Europe and Canada; Benicar Litigation MDL 2606 - District of New Jersey. NDEA and NDMA can be unintentionally introduced into manufacturing through certain chemical reactions. At least a dozen cardiovascular drugs have been recalled recently, including types of amlopidine, irbesartan, and valsartan. How do chemicals used in rocket fuel ever enter into the pill manufacturing process? Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The Food and Drug Administration announced Wednesday that it will expand its recall of blood pressure medicines to include four lots of losartan … Drug Recall List Last Updated: November 2020 Drug Recall Details Contact Date Drug Recall Class* Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877-993-8779. In January, several generic valsartan products sold in the United States were found to be contaminated with NDMA, another nitrosamine chemical associated with higher risk of colorectal and uterine cancers. Any other federal court proceedings, either pending in that court or awaiting transfer to the MDL; 3. BENICAR® (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. ISSUE: FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens … UPDATE: On August 1, 2017, a $300 million Benicar settlement. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. But unfortunately, 2018 brought widespread recalls of valsartan, a widely prescribed ARB, due to unexpected impurities. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients. This is the fifth recall in 2019; over the past year, dozens of batches of medications used to treat hypertension have been recalled over contamination fears. The agency sent manufacturers a letter April 4 to inform them about factors that can contribute to the formation of nitrosamine impurities during manufacturing and reiterated steps they should take to ensure these impurities are not present in any of their blood pressure medications in the future. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 1 year ago Williams seeks class action status after the Penumbra catheter recall, to pursue damages on behalf of himself and other investors who purchased common stock between August 3, 2020 … An FDA spokeswoman told NBC News that the agency could not predict how long the recalls would continue. 2.1 Hypertension. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available. Benicar Recall To date, the FDA nor Daiichi Sankyo, the maker of low blood pressure treatment medication, has yet to recall Benicar due to its link with causing sprue-like enteropathy. FDA warns about blood pressure medication shortages amid recalls, Torrent Pharmaceuticals expanded its recall, Mislabeling leads to recall of popular blood pressure medicine. Additional Information for Patients, for Healthcare Professionals and a Data Summary are provided in the Drug Safety Communication below.. 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. ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). It is used for the treatment of hypertension, or high blood pressure, in adults and children over the age of six. FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. The content on this page is provided for informational purposes only. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. The usual starting dose of telmisartan tablets, USP is 40 mg once a day. The Food and Drug Administration announced Wednesday that it will expand its recall of blood pressure medicines to include four lots of losartan after they were found to contain a cancer-causing chemical. FDA believes the benefits of ARBs continue to outweigh their potential risks. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. A man has his blood pressure checked at the Remote Area Medical (RAM) mobile dental and medical clinic on June 10, 2017 in Olean, New York. Olmesartan side effects. is longer reviewing new cases. [07/15/2010 - Drug Safety Communication - FDA]. 100 Million Dollar Settlement Fund for Women Injured by Nuvaring. The mean duration of follow-up ranged from 1.7 to 4.8 years. Olmesartan is also sold under the brand … Dosage for Benicar. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. Olmesartan (Benicar) is an oral medication used to treat high blood pressure. [07/03/2013 - Drug Safety Communication - FDA], Audience: Cardiology, Oncology, Family Practice. RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. “We know that the discovery of these genotoxic impurities, called nitrosamines, is alarming to patients who expect their products to be free from these types of impurities,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, in a statement. Learn about side effects, warnings, dosage, and more. The FDA Alert(s) below may be specifically about olmesartan or relate to a group or class of drugs which include olmesartan. BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Olmesartan is in a class of medications called angiotensin II receptor antagonists. Audience: Cardiology, Pharmacy, Family Practice, Endocrinology, Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics. According to the FDA, those recalls, which began in June of 2018, involve a number of angiotensin II receptor blockers (ARBs), a type of medication used to … Click here to access the latest company news regarding Glenmark’s commitment to our patients, people and communities as the COVID-19 pandemic evolves globally. “It is important to know that not all ARB products contain impurities, so pharmacists may be able to provide a refill of medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications,” he added. As a result, olmesartan relaxes the blood vessels. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm, Olmesartan Medoxomil Prescribing Information, Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch ". Potentially serious side effects of Benicar include: difficulty with breathing or swallowing, chest pain, cough, vertigo, abdominal pain, hyperkalemia, renal failure, and ; muscle tissue breakdown (rhabdomyolysis). The latest recall comes after Torrent Pharmaceuticals expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets last week, after finding trace amount of N-methylnitrosobutyric acid, another contaminant linked to cancer. 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: [06/24/2014 - Drug Safety Communication - FDA], Audience: Health Professional, Cardiology, Patient. Patients should consult their healthcare professional if they have any questions or concerns about taking Benicar. RECOMMENDATION: Health care professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop. The action taken by Aurobindo is the latest recall related to valsartan. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. Dosage must be individualized. Since July, recalls involving multiple companies and products have been announced, due to the presence of NDMA in active pharmaceutical ingredient (API) supplied by manufacturer Zhejiang Huahai Pharmaceutical Co Ltd, in Linhai, Taizhou Zhejiang, China. “Currently, valsartan, olmesartan and eprosartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon,” an FDA spokesman told NBC News. was reached with the drug makers to resolve certain claims for injuries stemming from use of Benicar, Benicar HCT, Azor or Tribenzor prior to May 2015. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.. Dr. Shamard Charles is a physician-journalist for NBC News and Today, reporting on health policy, public health initiatives, diversity in medicine, and new developments in health care research and medical treatments. Find out which specific blood pressure medications are affected by the recall. Jason T. Brown was the first attorney in the country to file a battery of cases on behalf of women who sustained blood clots, such as deep vein thrombosis, pulmonary embolisms, strokes and death from Nuvaring. [UPDATED 04/14/2011] After reviewing the results of the ROADMAP and ORIENT trials, FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Call your doctor at once if you have: a light-headed feeling, like you might pass out; Blood pressure response is dose-related … The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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). 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. RECOMMENDATION: Follow the recommendations in the drug label when prescribing Benicar. Available for Android and iOS devices. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo. I have unrelenting stomach issues including pain, gas, and diarrhea. The FDA said Friday there are shortages of the blood pressure medication valsartan due to recalls over contamination with a potentially cancer-causing chemical. Benicar is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients. Select one or more newsletters to continue. Not all versions of the widely used medications are contaminated, but ongoing recalls may cause shortages, an FDA spokesperson said. Olmesartan is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. It was first developed by Daiichi Sankyo, but has since been made by more than one manufacturer. It works by blocking a substance in the body that causes the blood vessels to tighten. Symptoms of sprue-like enteropathy include … Benicar is available in strengths of 5, 20, or 40 mg of olmesartan medoxomil tablets. ISSUE: FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. For an optimal experience visit our site on another browser. The affected product was … 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. [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. Patients should contact their health care professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss. Sharion January 21, 2020 at 1:20 pm Reply I have been taking Edarbi for approximately a year. According to the FDA, Legacy Pharmaceutical Packaging has recalled four lots of losartan because the batch contained trace amounts of the nitrosamine, NMBA, which has been linked to increased risk for bladder cancers. The U.S. Food and Drug Administration (FDA) approved Benicar in 2002 to treat high blood pressure, also known as hypertension. FDA will update the public when new information is available. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Recall expansions also were announced January 3 , January 22 , March 1, and April 18. Nearly 60 million prescriptions were written for losartan in 2016 — the ninth most prescribed drug in the U.S. — and nearly 14 million for valsartan or a drug that includes it. 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