Drug recalls are a pretty common occurrence nowadays and valsartan, a drug used to control blood pressure and prevent heart failure, is the latest drug to be hit with a recall (1). About 2,300 batches of valsartan has been recalled in a total of 22 countries because it contains a chemical that has the potential to cause cancer (1). Some countries that have implemented the recall include Canada, Germany, Italy, France, and Spain, but surprisingly, the US has yet to recall the drug (1).
Pharmaceutical manufacturer Sandoz, Inc. has also voluntarily recalled yet another medication for hypertension – Losartan Potassium Hydrochlorothiazide. This recall came after it tested positive for a chemical impurity that has been classified as cancer-causing.
It’s called N-nitrosodiethylamine (NDEA) and, according to the FDA, “has been classified as a probable human carcinogen as per International Agency for Research on Cancer.” (5)
NDEA occurs naturally in certain foods, drinking water, air pollution, and industrial processes.
“[The] suspected human and animal carcinogen… is used in gasoline as a stabilizer for industry materials and as a lubricant additive,” CNN reports. (6)
How to Identify the Product:
- Losartan Potassium Hydrochlorothiazide
- 100 mg/25 mg tablets in 1000-count plastic bottles
- NDC 0781-5207-10
- Lot number JB8912
- Expiry Date 06/2020
Patients with questions about the recall can contact Sandoz Inc. at 800-525-8747 or email email@example.com. Here’s where to find ongoing FDA updates.
Now, Why Was Valsartan Recalled?
The potential cancer risk associated with valsartan use was discovered when batches of valsartan’s active pharmaceutical ingredient (API) were tested by its supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China, and found to contain an impurity (2). The impurity is N-nitrosodimethylamine (NDMA), an organic chemical that has been classified as a likely human carcinogen (1,2).
NDMA is often used to make softeners, lubricants, and rocket fuel and is a by-product produced in the manufacturing of products including rubber tires and pesticides (2). Animal studies have revealed that NDMA is a toxic substance that can cause tumors in the kidney, liver, and respiratory tract (1). When exposed to humans in high levels, NDMA has the potential to cause liver damage (1).
The Future of Valsartan
The European Medicines Agency has since reviewed valsartan and concluded that the impurity is “a result of a change in the manufacturing process (1). Along with the EU, the European Medicines Agency is working to determine the impact this drug will have on patients and which other medications will be affected (1). More information will be released as investigations continue (2). For now, no other Sandoz or Novartis tablets, even those that contain valsartan, are being recalled (1).
Experts are urging patients to discuss alternative treatment options with their doctors as a precaution, but this doesn’t mean patients should stop taking their medication altogether (1,2). Dr. Sam Atkinson, the MHRA’s Director of the Inspection, Enforcement and Standards Division, stated that “People taking valsartan medication affected by this recall are advised to not stop taking their medication, but to speak to their doctor or healthcare professional who can advise alternative treatment” (2).
Traces of NDMA have been found in commercially available drugs in the past and one 1979 study found that 68 drugs containing amidopyrine also contained varying amounts of NDMA (3). The list of the drugs that have recently been recalled due to NDMA contamination include (4):
- TEVA-VALSARTAN/HCTZ TABLETS PP 30s
- TEVA-VALSARTAN/HCTZ TABLETS (Bulk)
- ACT-VALSARTAN 40MG FC TABLETS 100
- ACT-VALSARTAN 80MG FC TABLETS 100
- ACT-VALSARTAN 160MG FC TABLETS 100
- ACT-VALSARTAN 320MG FC TABLETS 100
- SANDOZ VALSARTAN 40 MG
- SANDOZ VALSARTAN 80 MG
- SANDOZ VALSARTAN 160 MG
- SANDOZ VALSARTAN 320 MG
- SANIS VALSARTAN 40 MG
- SANIS VALSARTAN 80 MG
- SANIS VALSARTAN 160 MG
- PRO DOC LIMITEE VALSARTAN 40 MG
- PRO DOC LIMITEE VALSARTAN 80 MG
- PRO DOC LIMITEE VALSARTAN 160 MG
- PRO DOC LIMITEE VALSARTAN 320 MG
- SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG
- SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG
- SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG
- SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG
(1) Christensen, J. (2018, July 6). Common heart drug recalled in 22 countries for possible cancer link. Retrieved from https://www.cnn.com/2018/07/06/health/valsartan-heart-drug-recall-intl/index.html
(2) Ochs, R. (2018, July 9). Heart and blood pressure medication recalled in 22 countries. Retrieved from https://www.europeanscientist.com/en/public-health/heart-and-blood-pressure-medication-recalled-in-22-countries/
(3) Eisenbrand, G., Spiegelhalder, B., Kann, J., Klein, R., Preussmann, R. (1979). Carcinogenic N-nitrosodimethylamine as a contamination in drugs containing 4-dimethylamino-2,3-dimethyl-1-phenyl-3-pyrazolin-5-one (amidopyrine, aminophenazone). Arzneimittelforschung, 29 (6), 867-9. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/582774
(4) Several drugs containing valsartan being recalled due to contamination with a potential carcinogen. (2018, July 9). Retrieved from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67202a-eng.php
(5) Office of Regulatory Affairs. (n.d.). Recalls, Market Withdrawals, & Safety Alerts – Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API). Retrieved from https://www.fda.gov/Safety/Recalls/ucm625492.htm
(6) Christensen, J. (2018, November 13). Blood pressure drug recall expands again. Retrieved from https://www.cnn.com/2018/11/12/health/heart-drug-recall-losartan/index.html
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