A recall of blood pressure medicines has been expanded as it may contain an impurity that could lead to cancer on prolonged exposure. It is one of the dozens of such recalls that began in July 2018.
While these recalls have caused panic in some, it is important to note, according to experts, that it would probably take years to develop cancer and stop the drug without it. An alternative would be more dangerous.
Torrent Pharmaceuticals Limited announced on Thursday that the recall for USP (Losartan Potassium Tablets) and USP (Losartan Potassium / hydrochlorothiazide Tablets) will be extended after traces of N-methylnitrosobutyric acid (NMBA) have been detected. NMBA is a known animal and potential human carcinogen, according to the Food and Drug Administration.
Torrent said it will recall only those lots of NMBA that are above the FDA accepted daily intake.
Here are the lots to look for
- Losartan Potassium Tablets, USP 50 mg, 1000 pieces
- NDC: 13668-409-10
- Batch #: 4DU2E009
- Expiration Date: 31.12.2020
Losartan Potassium Tablets, USP 100 mg, 90 pieces
- NDC: 13668-115-90
- Batch No.: 4DU3E009
- Expiration date: 31.12.2020
Losartan Potassium Tablets, USP 100 mg, 1000 pieces
- NDC: 13668-115-10
- Batch No.: 4DU3D018
- Expiry date: 28.02.2021
Losartan potassium / hydrochlorothiazide tablets, USP 50 mg / 12, 5 mg, 90 pieces
- NDC: 13668-116-90
- Batch No.: BEF7D051
- Expiry date: 30.11.2020
Losartan potassium / hydrochlorothiazide tablets, USP 100 mg / 25 mg, 90 count
- NDC: 13668-118-90
- Batch #: 4P04D007
- Expiration date: 31.07.2020
Nitrosamine contaminants such as NBMA that have led to the callbacks may be generated if, according to the FDA, certain chemicals and reaction conditions are present in the manufacturing process of the active pharmaceutical ingredient of the medicinal product. This could also be due to the reuse of materials such as solvents.
The risk of contracting cancer is low and, according to the FDA, will not happen overnight. The agency says that if someone took the highest daily dose of valsartan containing NDMA and took this medicine for four years, there would be an increased likelihood of developing cancer in 1 in 8,000 patients.
Dr. Eugene Yang, a UW Medicine physician in Seattle and adjunct professor of cardiology and medicine at the University of Washington, said earlier this year that most patients are not taking the highest dose, so even the 1 to 8,000 estimate is high.
Yang also said that blood pressure is significantly increased by discontinuation of these drugs, which increases the risk of heart attack or stroke. In general, it is recommended to take the drug until a doctor can prescribe an alternative.