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Generic drug makers continue to remove various blood pressure medications from the market, nearly a year after the first valsartan recalls were announced due to the presence of potentially cancer-causing contaminants that have become a byproduct of the manufacturing process.
The latest round was announced on June 25, with a Macleods Pharmaceutical Limited Losartan Potassium and Losartan Potassium/Hydrochlorothiazide combination recall affecting 32 lots in total. The recall came due to the excessive presence of N-Nitroso-N methyl-4-aminobutyric acid (NMBA).
NMBA is one of three impurities found in generic valsartan, losartan and irbesartan tablets manufactured in recent years. Other hypertension drug recalls have been linked to the presence of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). All three are known to increase the risk of cancer among humans.
The first problems with the presence of cancer-causing chemicals were linked to generic valsartan tablets in July 2018, after it was discovered that much of the U.S. supply of the generic drug had been distributed for years with the known human carcinogen. Since then, hundreds of product liability lawsuits have been filed by individuals diagnosed with cancer due to side effects of recalled valsartan, losartan and other blood pressure drugs, indicating that the cancer was caused by years of exposure to the contaminants.
This latest recall affects losartan tablets distributed by Macleods but manufactured by Hetero Labs of India. The level of NMBA detected in the tablets exceeded even the FDA’s much less stringent interim acceptable exposure limit of 9.82 parts per million. That exposure limit was lessened during the year-long stint of recalls due to the resulting hypertension drug shortage.
This latest recall affects two lots of Losartan Potassium USP Tablets at 50mg strength. It also affects 12 lots of Losartan Potassium/Hydrochlorothiazide combination Tablets at 50mg/12.5mg strength; 15 lots at 100mg/25mg strength, and three lots at 100mg/12.5mg strength.
The affected lots have expiration dates ranging from September 2019 to October 2021 and were distributed nationwide to Macleods wholesale distributor and retail customers. A full list of lot numbers, NDC numbers and expiration dates is available in the recall notice, linked above.
Patients taking the recalled tablets are advised to continue taking them until they can contact their pharmacist or physician in order to switch to an alternative tablet or treatment. The FDA has warned that the risk of adverse events from discontinuing the pills suddenly is significantly higher than the risk of cancer.
Consumers with questions regarding the recall, or who wish to report an adverse event can contact Macleods Pharmaceuticals Limited at 855-926-3384. Those with questions about returning the recalled tablets can contact Qualanex at firstname.lastname@example.org or by calling 888-280-2046.
The FDA also requests that adverse events be reported to the MedWatch Adverse Event Reporting Program.