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. 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. 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. Olmesartan is also sold under the brand … RECOMMENDATION: Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. 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. UPDATE: On August 1, 2017, a $300 million Benicar settlement. [07/15/2010 - Drug Safety Communication - FDA]. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. [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. 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. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.. BACKGROUND: FDA safety review was prompted by the results of the ROADMAP trial. IE 11 is not supported. ROADMAP and ORIENT are both long-term clinical trials. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. 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). Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. [06/02/2011 - Drug Safety Communication - FDA] An FDA spokeswoman told NBC News that the agency could not predict how long the recalls would continue. RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. 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. 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. For an optimal experience visit our site on another browser. By Shamard Charles, M.D. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. [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. [07/03/2013 - Drug Safety Communication - FDA], Audience: Cardiology, Oncology, Family Practice. The pills come in 100-count blister packs with NDC number 60687-139-01. Blood pressure response is dose-related … BENICAR® (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. 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. 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. 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 Food and Drug Administration announced Wednesday that it will expand its recall of blood pressure medicines to include four lots of losartan … To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients. Symptoms of sprue-like enteropathy include … In February, the House Energy and Commerce Committee wrote to former commissioner FDA Scott Gottlieb to inquire about inspections at overseas drug packaging plants. 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's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. RECOMMENDATION: Follow the recommendations in the drug label when prescribing Benicar. 100 Million Dollar Settlement Fund for Women Injured by Nuvaring. It was first developed by Daiichi Sankyo, but has since been made by more than one manufacturer. Not all versions of the widely used medications are contaminated, but ongoing recalls may cause shortages, an FDA spokesperson said. Learn about side effects, warnings, dosage, and more. No statistically significant difference in cancer deaths was noted. The disorder can be life-threatening. 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. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. is longer reviewing new cases. Benicar was developed and first manufactured by the Japanese company called Daiichi Sankyo. FDA will update the public when new information is available. 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. At least a dozen cardiovascular drugs have been recalled recently, including types of amlopidine, irbesartan, and valsartan. 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. “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. “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.”. 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 usual starting dose of telmisartan tablets, USP is 40 mg once a day. 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. Benicar is available in strengths of 5, 20, or 40 mg of olmesartan medoxomil tablets. This medicine is available only with your doctor's prescription. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. Saiontz & Kirk, P.A. 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. 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 action taken by Aurobindo is the latest recall related to valsartan. Sharion January 21, 2020 at 1:20 pm Reply I have been taking Edarbi for approximately a year. 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. The U.S. Food and Drug Administration (FDA) approved Benicar in 2002 to treat high blood pressure, also known as hypertension. FDA warns about blood pressure medication shortages amid recalls, Torrent Pharmaceuticals expanded its recall, Mislabeling leads to recall of popular blood pressure medicine. It is used for the treatment of hypertension, or high blood pressure, in adults and children over the age of six. Call your doctor at once if you have: a light-headed feeling, like you might pass out; 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. Another 3.6 million prescriptions were written for irbesartan that year. 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. Olmetec - olmesartan medoxomil sold in Europe and Canada; Benicar Litigation MDL 2606 - District of New Jersey. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. I have unrelenting stomach issues including pain, gas, and diarrhea. 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. It is often misdiagnosed as Celiac disease because it has similar symptoms including chronic diarrhea. Benicar is the brand name for the generic drug olmesartan medoxomil. Dosage for Benicar. 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. 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. Other drugs affected by the valsartan recall include losartan and irbesartan. 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 … 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. 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 … 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. For the latest FDA MedWatch alerts, go here. FDA believes the benefits of ARBs continue to outweigh their potential risks. But unfortunately, 2018 brought widespread recalls of valsartan, a widely prescribed ARB, due to unexpected impurities. The latest is American Health Packaging's 160 mg valsartan tablets, lot number 179791 that expire on March 31, 2020. 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. 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. In Re: Benicar (Olmesartan) Products Liability Litigation, MDL No. Losartan is a prescription medication used to treat high blood pressure and congestive heart failure. NDEA and NDMA can be unintentionally introduced into manufacturing through certain chemical reactions. Find out which specific blood pressure medications are affected by the recall. 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. Olmesartan is in a class of medications called angiotensin II receptor antagonists. 2606 (the “MDL”), a federal multi-district litigation venued in the United States District Court for the District of New Jersey; 2. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Olmesartan is an angiotensin II receptor blocker (ARB). 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