The FDA is adding more medications to the recall involving a cancer causing contaminant.
Made by Aurobindo, 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are being voluntarily recalled due to an active ingredient testing positive for N-nitrosodiethylamine (NDEA), an impurity known to cause cancer in animals.
Earlier this Fall, ScieGen Pharmaceuticals, Inc. recalled certain lots of irbesartan, a similar angiotensin receptor blocker used in blood pressure management.
The FDA globally expanded the recall of valsartan this summer due to an “impurity”, N-nitrosodimethylamine (NDMA) that is known to cause cancer in animals. Weeks later they additionally found traces of N-nitrosodiethylamine (NDEA).
According to Reuters, earlier this summer, the MHRA, Medicines and Healthcare Products Regulatory Agency, located in the UK, said the appearance of the impurity, N-nitrosodimethylamine (NDMA), came after a change in the process for making valsartan at one facility owned by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
In animals, NDMA is known to cause liver and lung cancer. In humans its carcinogenic risk is unknown, however the CDC states it may cause liver function impairment and cirrhosis.
With NDEA, data is limited, but due to its classification as a nitrosamine and its prevalence in tobacco smoke it is classified as a probable human carcinogen.
According to New Jersey Department of Health’s website, NDEA has been linked to liver, lung and gastrointestinal tract cancer in animals.
Losartan, valsartan and irbesartan are medications in the class of angiotensin receptor blockers (ARBs) used for high blood pressure and congestive heart failure.
Amlodipine is in the class of calcium channel blockers and appears to only be involved in this recall if in combination with the affected valsartan tablets.
Those taking either tablet for their blood pressure are urged to not abruptly stop their medication but rather check with their medical provider and pharmacy to see if their particular prescription is involved in the recall.
On the FDA’s website the following has been posted:
Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
I suspect more recalls will follow as processes may be similar across multiple pharmaceutical facilities and NDMA and NDEA are byproducts that may not be indivudally unique to just one “brand” of medication manufacturing.