More blood pressure drugs are being recalled after being found to contain trace amounts of a potentially cancer-causing ingredient, one of a slew of recalls of medications to treat hypertension.
Since last summer, drug companies have recalled hundreds of lots of blood pressure and heart medication drugs after tests showed small levels of potentially cancer-causing impurities.
The U.S. Food and Drug Administration weighed in on the recalls of multiple generic angiotensin II receptor blocker, or ARB, drugs, on Friday, saying the impurities may be the result of chemical reactions that occur in the drug-making process or from the reuse of materials, such as solvents.
"Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products," FDA Commissioner Scott Gottlieb said in a statement.
The latest such cases on Friday had two pharmaceutical firms expanding previous recalls.
Torrent Pharmaceuticals widened its recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets, the company announced late Friday. Earlier in the day, Aurobindo Pharma added 38 lots of Valsartan and Amlodipine and Valsartan tablets to a recall that started with 80 lots at the end of December. The recalled products have expiration dates ranging from October 2019 to July 2020. Click here for an updated list of Losartan products under recall.
The expanded recall comes a day after Camber Pharmaceuticals recalled 87 lots of Losartan Potassium, a prescription drug used to treat high blood pressure and congestive heart failure. Distributed nationwide online and by pharmacies and retailers including Walmart and Sam's Club, the drug was found to contain trace amounts of a potential human carcinogen, the New Jersey drug company said in a news release.
Packaged in 30-count, 90-count, 500-count and 1,000-count bottles, the recalled drugs contain the following National Drug Codes on their labels: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.
The affected Losartan tablets have expiration dates that run from September 2019 through June 2020.
The contaminant in Camber's drug, known as N-Nitroso N-Methyl 4-aminobutyric acid (NMBA), was detected in an active pharmaceutical ingredient manufactured by an Indian company, Hetero Labs. It's the first ARB recall involving the presence of NMBA, which is the third type of nitrosamine impurity detected in the medications, the FDA said.
Camber's recall is the second in a week of Losartan tablets. In a recall announced a week ago, Macleods Pharmaceuticals also identified Hetero Labs as manufacturing the active ingredient containing N-nitrosodiethylamine, or NDEA, a probable human carcinogen.
Camber and Macleods are among the half dozen pharmaceutical firms that have recalled hypertension drugs found to contain possible carcinogens since early December. Other companies to announce recalls include Maylan, Aurobindo Pharma and Torrent Pharmaceuticals, which also listed Hetero Labs as the source of the contamination in its recall. Prinston Pharmaceutical identified China's Zhejiang Huahai Pharmaceuticals as the source of NDEA found in its hypertension medication recalled by the company last month.
Both Zhejiang and Hetero have received warning letters from the U.S. Food and Drug Administration over their manufacturing practices.
For a list on FDA drug recalls, click here.
