Certain blood pressure drugs containing Losartan were recalled because they may contain a carcinogenic impurity that could potentially raise a user’s risk of cancer.
Check If Your Blood Pressure Drugs Were Recalled
The FDA will continue to update the list of products included in the recall as more information becomes available from ongoing testing. If patients take Losartan, Valsartan, or Irbesartan products, they should check the list periodically, as information may change.
What is the Risk?
- Stomach cancer
- Small intestine cancer
- Colorectal cancer
- Esophageal cancer
- Prostate cancer (only under 65 year olds)
- Liver cancer
- Blood cancer
- Bladder cancer
- Pancreatic cancer
- Multiple Myeloma
- Non-Hodgkins Lymphoma
Losartan Recalls Due to NMBA
In September 2019, Torrent Pharma expanded a recall for Losartan after tests detected a cancer-causing impurity called NMBA.
In April 2019, Torrent Pharmaceuticals Ltd. announced a voluntary recall for Losartan Potassium Tablets USP and Losartan Potassium/Hydrochlorothiazide tablets, USP due to the detection of the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
In April 2019, a recall was issued for 44 lots of Losartan potassium tablets manufactured by Teva Pharmaceuticals and labeled as Golden State Medical Supply due to the detection of NMBA. Additionally, Legacy expanded its recall to include 1 additional lot of Losartan tablets due to the detection of NMBA.
FDA Finds New Type of Carcinogen (NMBA)
The other two cancer-causing impurities are N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The FDA says “the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure.”
What is Losartan?
Losartan is a generic medication that treats high blood pressure (hypertension) and helps protect the kidneys from damage due to diabetes (nephropathy). Losartan can also lower the risk of strokes in patients with an enlarged heart.
What is the Problem?
A small amount of blood pressure medications containing Losartan have been linked to a possible risk of cancer due to a toxic chemical impurity that was left over from the drug’s manufacturing process. Patients may have been exposed to this toxic chemical for years.
April 2019 — Torrent Pharmaceuticals Ltd. announced a voluntary recall for Losartan Potassium Tablets USP and Losartan Potassium/Hydrochlorothiazide tablets. Teva Pharmaceuticals announced a recall for Losartan that was sold by Golden State Medical Supply. Legacy Pharmaceuticals also expanded its recall to include 1 additional lot of Losartan.
March 2019 — Torrent Pharmaceuticals Ltd. is recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, due to the detection of N-Methylnitrosobutyric acid (NMBA).
March 2019 — Camber Pharmaceuticals Inc. recalled 87 lots of Losartan because it may contain a cancer-causing impurity.
January 2019 — Torrent Pharmaceuticals announced an expanded recall for Losartan Potassium Tablets because they contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
December 2018 — Torrent Pharmaceuticals recalled 2 lots of Losartan due to NDEA.
November 2018 — Sandoz Inc. announced a voluntary recall for 100-mg/25-mg tablets of Hyzaar (Losartan and Hydrochlorothiazide). The bottles are marked with NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020, and distributed on or after October 8, 2018.
Blood Pressure Drug Recalls
What are NDEA, NDMA, and NMBA?
Losartan and other blood pressure drugs have been recalled due to 3 types of cancer-causing impurities:
- N-nitrosodiethylamine (NDEA)
- N-Nitrosodimethylamine (NDMA)
- N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
These are toxic chemicals that are left over as an impurity in the final drug. The carcinogens are generated in the manufacturing process — and specifically when drug-makers reuse certain materials, such as solvents. They are classified as a “probable human carcinogen” by the International Agency for Research on Cancer (IARC).