The FDA regulates those less stringently than the active ingredients that fight disease. The FDA maintains a … The three impurities are chemical compounds in the nitrosamines class and NDEA and NDMA are considered to be a probable cancer-causing risk in humans at certain exposure levels, and NDMA a potential one. Yet another blood pressure medication has been added to the list of recalled hypertension drugs. Zhejiang Huahai has said it has been in close contact with the FDA since the recall began. Facebook Share. Latest blood pressure medication recall list, updated September 2019. The drugs, angiotensin II receptor blockers (ARBs), work by widening or … An FDA statement Friday disclosed that the contaminants, called N-Nitrosodimethylamine and N-Nitrosodiethylamine, are created when "specific chemicals and reaction conditions are present . Fda.gov said the recall was due to t to the detection of trace amount of an unexpected impurity. Torrent Pharmaceuticals widened its recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets, the … He added that his letter referenced that "some bottles of valsartan were recalled because of purity issues" but did not mention them as carcinogenic. 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. 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. Keep reading to find information about the earlier Teva recall and voluntary recalls by many other companies that make blood pressure medications. Only Generics. By Howard Cohen / Miami Herald Sunday Dec 9, 2018 at 8:31 AM. 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. American Health Packaging added to the list of recalls on March 7, 2019. The peripheral adrenergic inhibitors work in the brain to block signals that tell blood vessels to constrict. Lawyers for plaintiffs, including 34 people and insurers that paid for contaminated drugs, filed a class-action complaint Monday claiming that Zhejiang Huahai's actions constitute "an explicit effort to conceal and destroy evidence and to willfully and recklessly introduce adulterated and/or misbranded" valsartan into the market. The U.S. Food and Drug Administration has updated its lists of valsartan and losartan-containing blood pressure medicines under recall due to the detection of an impurity considered carcinogenic above certain levels in the active pharmaceutical ingredient. See also: sub-topics. Mylan Pharmaceuticals Inc./Mylan Laboratories Limited. Another blood pressure medication has been recalled over concerns it could contain trace amounts of carcinogens. In the 1950s, reserpine was one of the few products on the market to treat hypertension. The company said it hadn't received any reports of patients being harmed related to the recall. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Advance Local. These product labels provided by fda.gov are for the Mylan recalled lots. Here are the Mylan products listed as under recall as of Nov. 20, 2018, at fda.gov. Blood pressure medication recall expanded again over potential cancer-causing ingredient. All rights reserved (About Us). Latest blood pressure medication recall list, updated September 2019. According to the assessments that it has posted online, the FDA hasn't yet screened valsartan that Valisure tested from Aurobindo Pharma Ltd., Lupin Ltd. and Novartis. © 2021 Advance Local Media LLC. An online pharmacy told U.S. regulators it found another cancer-causing chemical in widely prescribed blood-pressure pills, raising new questions about a complex global web of companies that produces medicine for millions of people. See list above for the lots recalled in December. Community Rules apply to all content you upload or otherwise submit to this site. The agency last revised its allowable solvent levels in 2017; the WHO classified DMF as a probable carcinogen in 2018. In addition, it has updated the list of valsartan medicines not under recall as of March 19. 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. “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. For people with high blood pressure, there’s a range of other approved medications available that may be safer and more effective than alpha-blockers and alpha-2 … Valsartan is a decades-old treatment for hypertension that is frequently combined with other medicines into a single pill. By Bloomberg . Twitter Share. Off-label. The FDA has said it thinks the potential carcinogens, known as nitrosamine impurities, are a result of the manufacturing processes the companies used. Alembic doesn't use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. Next 21 results. You may have recently heard that FDA has recalled several blood pressure medications. On Jan. 3, 2019, Torrent Pharmaceuticals Limited expanded  its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, according to fda.gov. (RNN) – A recall traced to the widely-used blood pressure medication valsartan has expanded to two new products, produced by a previously affected drugmaker. By Bloomberg . Valisure found DMF in valsartan made by five of the six drugmakers it tested, including Novartis, which makes the brand-name version called Diovan. The company added five lots of the generic drug losartan (three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets) to an April recall of more than 100 lots of the same medications. This recall was prompted 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, Unit – I (API manufacturer). 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. The agency is urging patients to continue taking their medications until a pharmacist or doctor provides another option because they need to balance the risks of out-of-control blood pressure against that of a tiny elevated risk of cancer. On Jan. 22, 2019, Torrent Pharmaceuticals Limited expanded  its voluntary recall to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. 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. The latest news is that Torrent Pharmaceuticals Limited is further expanding its recall of Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, … NDEA has been classified as a “probable human carcinogen” according to the International Agency for Research on Cancer. An FDA spokeswoman said the investigation continues and it is impossible to predict how many more recalls there might be. … Kirk Hessels, a spokesman for Camber, didn't immediately respond to requests for comment on Friday. It is rarely used due to its numerous side effects and drug interactions. —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). The drugs under voluntary recall block receptors in the body that contribute to conditions like high blood pressure. 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. Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. There was a time when the high blood pressure medication list was very short indeed. The agency said that the risk of a patient who took a recalled ARB getting cancer is low. Lower in the list are the Teva Pharmaceuticals lots under voluntary recall, as posted at fda.gov. These batches were distributed domestically between March 2017 and November 2018. The recalls were over the presence of NMBA. Community Rules apply to all content you upload or otherwise submit to this site. A Bloomberg News investigation this year detailed efforts at the company to manipulate data and ignore warning signs that their drugs didn't meet U.S. standards. That drug was first approved in the U.S. in 1996. Rx. Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Medications for high blood pressure include: Diuretics; Beta-blockers; ACE inhibitors; Angiotensin-receptor blockers; Calcium channel blockers; Alpha-blockers. Getty Images. 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 agency said those byproducts would not have been detected in routine inspections because the process depends on scientists knowing which chemical intruders are likely to be accidentally created during the process, knowledge that they said regulators and companies lacked until recently. 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. 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 … If you take valsartan for your high blood pressure, check the FDA lists. ** Most commonly prescribed blood pressure medications have an array of similar side effects. Updated June 27, 2019, with new recall lots. 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