A generic drug company has recalled three commonly prescribed blood pressure medications over concerns they could include small amounts of a cancer-causing impurity. The recalled drugs all include the blood-pressure medication valsartan, the subject of a series of recalls by several drug companies since July. The generic drug company Mylan Pharmaceuticals recalled 104 lots of three medications: valsartan tablets, combination tablets with the drugs valsartan and amlodipine, and combination tablets with valsartan and hydrochlorothiazide. Testing revealed that valsartan contained trace amounts of N-nitrosodiethylamine, or NDEA, a possible human carcinogen, the company said. Amlodipine and hydrochlorothiazide in standalone form are not subject to the recall. Alternative medications are available. Mylan said patients should consult their doctor or pharmacist before stopping their current medication. More news like this? :Get news straight to your inbox. Subscribe here to get the Daily Briefing. More:Doctors: Blood pressure drug substitutes are available for patients affected by recalls More:Two more blood pressure drugs recalled for potential cancer risk More:FDA chief: Blood pressure medicine recalls reflect increased scrutiny on drug safety Throughout the recalls, doctors have said that stopping a medication without a replacement drug could cause a patient more harm than continuing the drug. People with questions about the recall can call 888-406-9305. They may view a list of Mylan's recalled drugs here. The Food and Drug Administration is investigating the cause of the contaminated drugs, originally traced to a large factory in China and later a second factory in India. Both used a similar manufacturing process to make and and supply valsartan to generic drug companies worldwide. Testing showed the factories made valsartan that contained N-nitrosodimethylamine, or NDMA, a possible human carcinogen. In September, the FDA said testing revealed a second contaminant, NDEA, in certain valsartan drugs. Several pharmaceutical companies have announced recalls of versions of valsartan, irbesartan and losartan. The recalled drugs are part a large class of drugs called angiotensin II receptor blockers. These drugs work by widening or relaxing blood vessels, thus lowering blood pressure. Consumers can view a complete list of FDA updates on the recalls here. FDA officials said the factories that supplied the contaminated drugs have been placed on import alert, which means drugs are no longer being shipped to the United States from these manufacturers. Factories that make drugs abroad are subject to inspection by the FDA. They are required to inform regulators about changes in how they make the drug ingredients. "We still don’t understand the complete root cause of this problem," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told USA TODAY this week. "We understand part of it. We don’t understand all of the steps that led to this." Woodcock said all "sartan" medications are being tested to ensure they don't contain impurities. She said no contaminants have been found in Novartis' Diovan, the brand drug version of valsartan. Drug companies are aware of the problem and required to do extensive testing, Woodcock said. "I would think these recalls would start dropping off now," she said. "We’ve had this import alert in place for quite a long time, and the companies buying from these sources were told to check and recall." She said the FDA will make public results of its root-cause investigation. The agency will also review its oversight. "We don’t want incidents like this to happen," she said. "So we’re going to have to look at how we managed oversight of change control of manufacturing processes."<doc-sep>A drug company on Friday announced the recall of eight more lots of irbesartan blood pressure medication after testing revealed the drugs contained trace amounts of a carcinogen. Prinston Pharmaceuticals recalled one lot of irbesartan tablets and seven lots of irbesartan HCTZ tablets. The medication contained unacceptable levels of the probable carcinogen nitrosodiethylamine, or NDEA, the company said. The drugs ingredients were made by Zhejiang Huahai Pharmaceuticals, a factory in China that has been linked to several recalls of commonly prescribed blood pressure drugs since July. The Food and Drug Administration has issued a warning letter and halted all new drug shipments from Zhejiang Huahai since uncovering a series of problems at the factory. Another factory in India, Hetero Labs Limited, also has been tied to multiple recalls. The irbesartan recall is the latest involving a large class of blood pressure drugs called angiotensin II receptor blockers, which work by blocking the effects of a hormone that narrows blood vessels. Several versions of valsartan and losartan also have been recalled since July. Many of these commonly prescribed drugs are not part of the recall. Consumers can check the FDA's website for a full list of recalled drugs or ask their pharmacist. More:Do you have high blood pressure? It depends on which doctor you ask More:Blood pressure drug recall: FDA investigates foreign plants that made drugs with cancer-causing impurities More:Three more blood pressure drugs recalled over cancer concern: Here's what you need to know More:More blood pressure medication recalled over carcinogen concerns — this time, losartan Prinston advised patients to check with their doctor or pharmacist before they stop taking their medications. Discontinuing a recalled drug could cause more immediate harm than staying on the medication. Prinston said the following irbesartan and irbesartan hydrochlorothiazide tablets have been recalled: • Irbesartan, 300 mg, 90 count, lot number 331B18009, expires February 2021 • Irbesartan HCTZ, 300 mg/12.5 mg, 30 count, lot number 327A18001, expires March 2021 • Irbesartan HCTZ, 300 mg/12.5 mg, lot number 327A18002, expires March 2021 • Irbesartan HCTZ, 300 mg/12.5 mg, 90 count, lot number 327B18008, expires March 2021 • Irbesartan HCTZ, 300 mg/12.5 mg, 90 count, lot number 327B18009, expires March 2021 • Irbesartan HCTZ, 150 mg/12.5mg 30 count, lot number 325D18004, expires March 2021 • Irbesartan HCTZ, 150 mg/12.5 mg, 90 count, lot number 325B18004, expires March 2021 • Irbesartan HCTZ, 150 mg /12.5 mg, 30 count, lot number 325D18005 expires March 2021<doc-sep>The recall is sparked by “the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals,” the news release states. The substance is N-nitrosodiethylamine, and the medications recalled were found to have above the acceptable daily intake levels released by the Food and Drug Administration. As The AJC previously reported, the impurity, typically found in certain foods, drinking water and air pollution, has been classified as a human carcinogen by the International Agency for Research on Cancer.<doc-sep>Numerous blood pressure medications in recent months have been recalled over concerns of possibly carcinogenic ingredients, leaving some consumers wondering how to tell whether their medicines are safe. Since July, dozens of the medications have been recalled because of trace amounts of N-Nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA) in the products, according to the Food and Drug Administration. NDMA and NDEA are probable carcinogens, and the FDA has found levels of the impurities in three drugs: valsartan, irbesartan and losartan-containing products, the agency says. The recalled drugs are part a large class called angiotensin II receptor blockers (ARBs). These drugs work by widening or relaxing blood vessels, thus lowering blood pressure. To find out whether your medication is under recall, check the FDA website for all three drugs. For valsartan-containing products currently recalled, click here. For irbesartan-containing products currently recalled, click here. For losartan-containing products currently recalled, click here. Not all ARBs contain NDMA or NDEA or are under recall, the FDA says. Consumers should not stop taking their medication without an alternative or replacement from their pharmacist or doctor, the agency said. For valsartan-containing products not currently recalled, click here. For more information on the recalls, read all of USA TODAY's coverage here: Jan. 23:Blood pressure medication recall over cancer risk expanded for more losartan drugs Jan. 18:FDA: Another blood pressure drug, irbesartan, recalled over cancer-causing impurity Jan. 14:Blood pressure drug recall: FDA investigates foreign plants that made drugs with cancer-causing impurities Jan. 7:More blood pressure medication recalled over carcinogen concerns — this time, losartan Jan. 2:More blood pressure medication recalled: Company recalls 80 lots of valsartan over cancer concerns Dec. 6:Three more blood pressure drugs recalled over cancer concern: Here's what you need to know Nov. 30:Doctors: Blood pressure drug substitutes are available for patients affected by recalls Nov. 30:Two more blood pressure drugs recalled for potential cancer risk Nov. 14:FDA chief: Blood pressure medicine recalls reflect increased scrutiny on drug safety Nov. 13:FDA recalls another blood pressure drug for possible cancer risk Nov. 2:Blood pressure drug recalled for possible cancer risk, FDA says Aug. 7:FDA expands recall of heart drug for possible cancer-causing contamination Contributing: Ken Alltucker, USA TODAY. Follow USA TODAY's Ryan Miller on Twitter: @RyanW_Miller<doc-sep>
Another drug company has recalled a version of losartan blood pressure medication over concerns the drug contains tiny amounts of a carcinogen. Torrent Pharmaceuticals last week recalled eight more lots of losartan potassium tablets, on top of the two it recalled last month. In a notice shared by the Food and Drug Administration, the India-based pharmaceutical company said the medication used to treat high blood pressure and diabetic kidney disease contained unacceptable levels of the human carcinogen N-nitrosodiethylamine. The drugs contained an active ingredient made by Hetero Labs in India, one of two overseas factories linked to more than a dozen recalls of commonly prescribed blood pressure drugs since July. More:Three more blood pressure drugs recalled over cancer concern: Here's what you need to know More:FDA recalls another blood pressure drug for possible cancer risk More:FDA Chief: Blood pressure medication recall reflects increased scrutiny The recalled drugs include versions of valsartan, losartan and irbesartan, either alone or in combination with other drugs. Consumers can view a complete list of FDA updates on the recalls, including affected dosages and drug combinations, on the agency's website. The recalled drugs are part a large class of drugs called angiotensin II receptor blockers, which work by blocking the effects of a hormone that narrows blood vessels. ARBs and another class of drugs called angiotensin converting-enzyme inhibitors, or ACE inhibitors, are often the first drugs doctors recommend to lower a patient's blood pressure. Physicians and researchers representing the American College of Cardiology, the American Heart Association and nine other groups adopted new guidelines in 2017 that estimated 103 million U.S. adults had high blood pressure, up from 72 million based on an earlier standard. They described blood pressure of 130/80 to 139/89 as "stage one" hypertension, a more aggressive benchmark than the 140/90 used previously. People with stage one hypertension might be able to lower their blood pressure by lifestyle changes such as losing weight, exercising more, or adjusting diet to include more fruits and vegetables and less salt. The researchers estimated that 36 percent of adults should be treated with medication. Drug companies that have issued recalls have urged customers to consult with their doctor or pharmacists before they stop taking their medications. Discontinuing a drug with trace amounts of a carcinogen could put a patient at greater risk than simply staying on the drug. Several blood pressure-lowering drugs have not been affected by the recalls. The FDA is investigating the root cause of the drug contamination at Zhejiang Huahai Pharmaceuticals in Linhai, China and Hetero Labs in India. Both companies used a similar manufacturing process to make and and supply ARB ingredients used by generic drug companies worldwide. Testing showed the factories made valsartan that contained N-nitrosodimethylamine, or NDMA, a possible human carcinogen. In September, the FDA said testing revealed the N-nitrosodiethylamine, or NDEA.