Two More Blood Pressure Drugs Added to Ongoing FDA Recall
October 14, 2019 | Pharmaceutical Litigation
The U.S. Food and Drug Administration’s voluntary blood pressure drug recall continues as Torrent Pharmaceuticals Limited announced it is expanding its nationwide recall to include two blood pressure medications that were found to contain trace amounts of a potential cancer-causing carcinogen.
The two medications are 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/hydrochlorothiazide tablets, USP manufactured by Hetero Labs Limited. Amounts of N-methylnitrosobutyric acid (NMBA) above the FDA acceptable ingestion level were detected during testing.
The blood pressure drug recall began in July of 2018 when the FDA recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan, and Irbesartan- medications used to treat hypertension and heart failure.
These medications can contain N-Nitrosodimethylamine (NDMA), or N-Nitrosodiethylamine (NDEA) and exposure can cause liver cancer, stomach cancer, intestinal cancer, colorectal cancer, kidney cancer, or blood cancer.
One pharmacy claims to have found the probable carcinogen dimethylformamide (DMF) in some Valsartan products as well. The medication ranitidine, brand-name Zantac, for treating heartburn, ulcers, and gastroesophageal reflux disease has also been recalled due to NDMA impurities.
This contamination happens during the manufacturing process; they are not impurities inherent in the medications.
The severity of the risk that these medications will cause cancer in users is unknown, although the FDA had previously stated they believe it to be quite low for those taking Valsartan.
“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. Most patients who were exposed to the impurity through the use of affected valsartan received less exposure than in the scenario described above,” the FDA stated.
Drug recalls are frequent occurrences, and they don’t always mean a drug poses health risks. Sometimes, a medication is considered defective for manufacturing or labeling reasons that don’t comply with FDA guidelines.
Drug recalls are voluntary actions taken by pharmaceutical companies to remove a drug from the market when a medication is deemed unsafe or unfit.
Recalls can occur with or without an FDA request, but the companies have to recall the medication, the FDA does not have that authority to do so.
There are three types of recall classifications: class I includes any product that is likely to cause serious health problems; class II includes any product that could temporarily cause a health problem; class III includes any product that is not likely to cause a health problem but violates FDA laws in some other way.
The FDA posts all recalls weekly in its Enforcement Report. They are currently continuing to test ARBs for impurities. Companies typically publicly announce a drug recall, and pharmacists and health care professionals notify patients directly.
Patients are then instructed on next steps, including how to return the recalled medication to their pharmacy. Torrent Pharmaceuticals Limited is currently informing its customers and distributors about the recall through phone calls, letters, and emails.
Companies participating in the ARB recall include: A-S Medication Solutions LLC; Acetris Health, LLC; Actavis Pharma, Inc.; American Health Packaging; Aurobindo Pharma USA, Inc.; AvKare, Inc.; Bryant Ranch Prepack Inc.; Camber Pharmaceuticals, Inc.; Golden State Medical Supply; GSMS Incorporated; H J Harkins Company Inc. / Pharma Pac; Heritage Pharmaceuticals Inc; Legacy Pharmaceutical Packaging, LLC; Macleods Pharmaceutical Ltd.; Major Pharmaceuticals; Mylan Pharmaceuticals, Inc.; Northwind Pharmaceuticals; NuCare Pharmaceuticals Inc.; Preferred Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc., dba Solco Healthcare LLC; RemedyRepack Inc.; Sandoz Inc.; Solco Healthcare LLC; Teva Pharmaceuticals USA Inc.; Torrent Pharmaceuticals Limited; and Westminster Pharmaceuticals.
The FDA instructed patients taking any of the recalled blood pressure medication to continue taking it as prescribed until their pharmacist or doctor gives them a different option.
It is dangerous to suddenly stop taking medication.
If you are unsure if your medication has been recalled, check the FDA’s list of recalled ARBs. Look up your medication by name, manufacturer, expiration date, and batch or lot number. It is important to do this as the recall may not mean that your pills in particular are contaminated, they may be a different brand or from a different batch.
Any patient prescribed an ARB should regularly check the FDA website for updates.
Contact your physician or healthcare provider with questions and concerns about your medication. If you need to report a medical problem regarding this recall contact Torrent Pharmaceuticals Limited at 1-800-912-9561 or Medinfo.Torrent@apcerls.com.
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