The drugs under voluntary recall block receptors in the body that contribute to conditions like high blood pressure. The official had recommended Zhejiang Huahai, one of China's largest exporters of pharmaceuticals, receive a warning from the agency, but was overruled by higher-ups at the FDA. Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters There was a time when the high blood pressure medication list was very short indeed. Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. The peripheral adrenergic inhibitors work in the brain to block signals that tell blood vessels to constrict. —The 104 additional lots include 26 lots of Amlodipine and Valsartan tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths). “But most people probably would not do that.”, The FDA has said in its information for consumers, “Our scientists estimate that if 8,000 people took the highest daily valsartan dose (320 mg) that contained NDMA, for four years (the amount of time we believed the affected products had been on the U.S. market), there may be one additional case of cancer beyond the average cancer rate among Americans.”. Fda.gov said the recall was due to t to the detection of trace amount of an unexpected impurity. American Health Packaging added to the list of recalls on March 7, 2019. See below for previous Torrent recalls of other blood pressure medications. The U.S. Food and Drug Administration has updated its lists of valsartan and losartan-containing blood pressure medicines under recall due to the … Community Rules apply to all content you upload or otherwise submit to this site. The FDA allows drugs to contain the equivalent of about 8.8 million nanograms of daily exposure to DMF. The government site also says the risks of going off the medication may be greater than the risk of taking it so patients should not stop but should contact their health care provider or pharmacist for guidance. NDEA has been classified as a “probable human carcinogen” according to the International Agency for Research on Cancer. FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure FRIDAY, March 8, 2019 -- People taking blood pressure medications have faced a frightening and bewildering series of pharmaceutical recalls in recent months, as trace amounts of cancer-causing chemicals have been discovered in … For now, if you are taking blood pressure medications, or any medications for that matter, pay attention to FDA warnings and recall news. Carton NDC#: 60687-139-01 Need exclusive stories only we can tell? A Food and Drug Administration recall of a heart medication due to a cancer-causing chemical now includes two blood pressure medications. Blood Pressure Medication Recalled FDA says active ingredient is linked to a known probable carcinogen. . The agency has downplayed the public health risks of the contamination, pointing out that if 8,000 people took the highest dose of one drug, valsartan, for four years, there could be one additional case of cancer. “Trace amounts normally wouldn’t worry me, but trace amounts - along with other exposures - build up and that is my concern with carcinogens and taking something tainted everyday,” the consumer said. The FDA said March 20 that to “ensure patient access to losartan” that it will “not object to certain manufacturers temporarily distributing losartan” with NMBA above the interim acceptable intake levels “of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated.". For people with high blood pressure, fluctuating readings are a warning sign that you might need to change medication. / Blood Pressure Medication Recall List. Facebook Share. (RNN) – A recall traced to the widely-used blood pressure medication valsartan has expanded to two new products, produced by a previously affected drugmaker. Kirk Hessels, a spokesman for Camber, didn't immediately respond to requests for comment on Friday. The U.S. Food and Drug Administration is alerting patients and health care professionals to another recall of medications used to treat high blood pressure and heart failure due to the presence of a potential cancer-causing substance. Torrent Pharmaceuticals Limited recalled two lots of Losartan potassium tablets, USP because of trace amounts of N-nitrosodiethylamine (NDEA), which is a probable human carcinogen. Teva Pharmaceuticals has issued a voluntary recall of its amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets, both used to treat high blood pressure, according to the FDA. FDA has issued a recall of certain lots of angiotensin II receptor blocker (ARB) high blood pressure medication containing valsartan, losartan, or irbesartan. A representative for Macleods couldn't be reached for comment. Some of the valsartan that was positive for DMF was on a list of medicines the FDA had earlier deemed safe to use amid the recalls, including drugs manufactured by Alembic Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., both based in India. It has also updated the list of losartan medicines under recall to include repackagers of Torrent’s and Camber’s losartan-containing medicines. New research presented today at … Next 21 results. The FDA posted Mylan labels, also at fda.gov. Rx. Latest blood pressure medication recall list, updated September 2019. Plaintiffs' attorneys also filed a separate class-action complaint on behalf of patients who took contaminated valsartan and are seeking payment for medical monitoring for everyone who took the tainted drugs. Which blood pressure medication that has the lowest side effects depends on how you react to specific medications and what side effects you find most bothersome. (Individual Dose NDC: 60687-139-11). Registration on or use of this site constitutes acceptance of our User Agreement, Privacy Policy and Cookie Statement, and Your California Privacy Rights (each updated 1/1/21). Approval was granted to India-based Alkem Laboratories Limited. Here are the 10 lots. According to fda.gov, as of Feb. 22, 2019: Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited. Blood pressure medication recall expanded again over potential cancer-causing ingredient. Is your blood pressure medication on growing recall list? The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Advance Local. In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds. To break them down, a solvent like DMF may be used, but it's supposed to largely vanish by the time a pill is put into a bottle for sale. But the official limit considered "safe" for human consumption brings a much lower risk than the possible exposure from tainted drugs - causing less than one additional case of cancer in 100,000 people over a lifetime. and may also result from the reuse of materials, such as solvents." This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). Some forms of valsartan may contain a cancer-causing agent, FDA says. An Attorney who has filed 12 high blood pressure medication lawsuits so far, told judges at a conference in the U.S. District Court in New Jersey last month he expected there to be at least 2000 high blood pressure medication lawsuits filed within the next two years. More blood pressure drugs are being recalled after being found to contain trace amounts of a potentially cancer-causing ingredient, one of a slew of recalls of medications to treat hypertension. FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure Off-label. Diovan's DMF levels were among the lowest that tested positive. » RELATED: Blood pressure medication recalls: Everything you should know, Atlanta doctors, experts say The FDA said in a March 22 posting on its website that it has updated the list of valsartan medicines under recall to incorporate additional repackagers of Aurobindo’s valsartan-containing medicine. Yet another blood pressure medication has been added to the list of recalled hypertension drugs. Facebook Share. Twitter Share. Getty Images. Here are the Teva lots under recall as of November 2018, according to fda.gov. Problems with potential cancer-causing agents in blood-pressure medications first cropped up in July, when an ARB called valsartan was recalled by Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. A Bloomberg investigation found that an FDA inspector had raised concerns at the factory that made the valsartan in May 2017. The Food and Drug Administration has recently recalled a number of … As of March 1, 2019, AurobindoPharmaUSA expanded its voluntary recall. In addition, it has updated the list of valsartan medicines not under recall as of March 19. The impurity detected in the finished drug product is N-nitrosodiethylamine, which is has been classified as a probable human carcinogen. DMF, as the solvent is known, is classified by the World Health Organization as a probable carcinogen. By Bloomberg . Teva Pharmaceuticals has issued a voluntary recall … Registration on or use of this site constitutes acceptance of our User Agreement, Privacy Policy and Cookie Statement, and Your California Privacy Rights (each updated 1/1/21). All rights reserved (About Us). © 2021 Advance Local Media LLC. OTC. "This is what made me look up the website given in the letter on the FDA recall," he said. All rights reserved (About Us). by Kent Allen, AARP, August 7, 2018 | Comments: 0. An expansion of the recall was announced March 19, 2019, on fda.gov: As of March 15, 2019, according to fda.gov: Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. According to fda.gov: NMBA is a potential human carcinogen. More blood pressure medications added to growing recall list The drugs are manufactured by Teva Pharmaceuticals. The FDA has added 80 lots of Amlodipine Valsartan blood pressure medication to the hypertension drug recall list that continues to grow. Top Searches Holiday Gifts. According to the Food and Drug Administration, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. The Food and Drug Administration (FDA) is issuing a worldwide recall for a blood pressure and heart failure medication that contains an active ingredient linked to an impurity that is a known probable human carcinogen. In standalone and combined forms, valsartan has been a go-to therapy for cardiovascular issues for a generation. Valisure found DMF in valsartan made by five of the six drugmakers it tested, including Novartis, which makes the brand-name version called Diovan. In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds. For a complete list of the recalled medication, click here. Camber said in a statement on Thursday that it was recalling 87 lots of losartan tablets due to the discovery. The lots similarly were found to contain N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the U.S. Food and Drug Administration … Reminder: Don’t stop your medicine without contacting your healthcare provider .The risk of abrupt discontinuation of BP drugs can be significant. Getty Images. FOLLOW ANNALISE KNUDSON ON FACEBOOK AND TWITTER . Medications for high blood pressure include: Diuretics; Beta-blockers; ACE inhibitors; Angiotensin-receptor blockers; Calcium channel blockers; Alpha-blockers. To date, Legacy has not received any reports of adverse events related to this recall. Late last month, Teva Pharmaceuticals pulled all lots of Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets for the same reason: too much NDEA in its Valsartan, the active ingredient made by Mylan India. Community Rules apply to all content you upload or otherwise submit to this site. 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