In July 2018, the US Food and Drug Administration announced a voluntary recall of several medications containing the active ingredient valsartan, which is commonly used to treat heart failure and high blood pressure. The valsartan recall was issued after it was found that certain batches contained a potentially dangerous impurity, N-nitrosodimethylamine (NDMA), which is classified as a “probable carcinogen in humans.”
Valsartan is not patented by a pharmaceutical company and is used as a component in numerous generic medicines, raising safety concerns among thousands of patients. While not all valsartan-containing drugs have been recalled for this contamination, more than a dozen drug makers have pulled their blood pressure medications off shelves at the FDA’s request.
Showard Law Firm is currently investigating claims on behalf of patients who were diagnosed with cancer or other adverse side effects after taking valsartan. Our accomplished product liability attorneys are experts in mass tort litigation against Big Pharma and have what it takes to hold negligent defendants accountable for their actions. A successful valsartan lawsuit can net monetary damages to account for lost income, medical expenses, emotional trauma, diminished earning capacity and other losses suffered. To find out if you or a loved one is eligible for legal action concerning valsartan injuries, we encourage you contact us for a confidential consultation, free of charge.
Valsartan recall based on cancer-causing impurities
In the valsartan recall notice, federal health regulators stated that after carefully evaluating valsartan-containing drugs sold in the U.S., certain batches sold by various companies did not meet the agency’s safety standards. The unexpected presence of NDMA in valsartan medications is believed to be related to changes in the manufacturing process. The FDA’s valsartan safety review is ongoing, as officials investigate N-nitrosodimethylamine levels in the recalled medications, weighing the possible risks to patients who have been ingesting them.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” said Scott Gottlieb, M.D., FDA Commissioner.
NDMA, also known as NDEA, is a semi-volatile chemical compound that is produced in several industrial processes and found in very minute levels in smoked or cured food products. The compound has been used to produce rocket fuel and is highly toxic to the liver, as evidenced by studies on lab animals who developed cancerous tumors after exposure to high levels of NDMA.
Medical professionals are concerned that even short-term exposure to NDMA can lead to liver damage, tumor formation and other health complications. The FDA cautions that patients should review their prescription bottles (specifically the manufacturer’s name and drug name) to determine whether their valsartan medication has been included in the recall.
Companies included in the recall
The FDA encourages individuals who are currently taking valsartan to continue the medication since suddenly stopping blood pressure medication can have adverse consequences. Patients are asked to contact their health care providers about the best course of action, whether it is ordering a new batch of non-contaminated valsartan or starting an alternate therapy.
Only valsartan-containing tablets and pills that test positive for NDMA above the acceptable level are included in the national recall. As of late 2018, this includes certain lots manufactured by the following drug makers:
- Teva Pharmaceuticals labeled as Major Pharmaceuticals
- Teva Pharmaceuticals USA labeled as Actavis,
- A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco)
- Prinston Pharmaceutical, labeled as Solco Healthcare LLC
- RemedyRepack Inc. (Prinston/Solco),
- AvKARE (Teva/Actavis)
- AvKARE (Hetero/Camber)
- Hetero Labs, Inc. labeled as Camber Pharmaceuticals
- H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco)
- Torrent Pharmaceuticals Limited
- RemedyRepack, Inc. (Torrent)
- RemedyRepack, Inc. (Hetero/Camber)
- Bryant Ranch Prepack Inc.
- Northwind Pharmaceuticals (Teva/Actavis),
- Preferred Pharmaceuticals, Inc. (Hetero/Camber),
- NuCare Pharmaceuticals Inc. (Prinston/Solco)
The blood pressure medicine recall includes some valsartan-containing batches that aren’t set to expire until 2020, so patients are advised to look closely at their bottle labeling.
The external distributor linked to the valsartan contamination has been stopped since the recall, but some critics wonder if this action is too late for thousands of patients. Meanwhile, the FDA has been working with the affected manufacturers to reduce the likelihood of future contamination and drug recalls.
Valsartan cancer risk
The cancer risks posed by contaminated tablets of valsartan has not yet been established in humans, but many health care providers are switching their patients off medicines supplied by one of the affected drug companies. There are several blood pressure medications currently available in the U.S. that may provide a safe substitute to valsartan. These include irbesartan, losartan, olmesartan and others. Patients should discuss the potential alternatives and risks with their physician when choosing the safest and most effective blood pressure medication.
In the meantime, patients are asked to report any adverse events from valsartan-containing medicines to the FDA’s Med Watch Program as the agency investigates the NDMA contamination.
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Showard Law Firm is a leader in drug injury litigation and understands the horrendous consequences of defective pharmaceutical products. Our legal team works on a contingency basis and never charges any fees unless a settlement or verdict is recovered on your behalf.
If you or someone you love have been affected by the valsartan recall, contact Showard Law Firm to arrange a free case evaluation.
Additional Resources:
- FDA, FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan https://www.fda.gov/drugs/drugsafety/ucm613916.htm
- Fortune, FDA Warns Sixth Valsartan Blood Pressure Drug Recalled for Contamination http://fortune.com/2018/11/29/fda-valsartan-blood-pressure-drug-recall-hypertension/
- Caremark, Drug Safety Alerts Valsartan Tablets Voluntary recall https://www.caremark.com/wps/portal/FOR_HEALTH_PROS_DRUG_SAFETY_ALERTS?cms=CMS-PWCM-1107679
- FDA, Valsartan products under recall https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf?utm_campaign=FDA%20updates%20recalled%20valsartan-containing%20product%20information&utm_medium=email&utm_source=Eloqua