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A new round of recalls involving losartan and similar hypertension drugs is underway, after investigators found yet another potentially cancer-causing agent in generic versions of the drugs.
The FDA issued a press release on March 1, warning that some blood pressure medications, known as angiotensin II receptor blockers (ARBs) may contain N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), which is a likely human carcinogen.
The impurity was found in losartan tablets at levels that exceed the FDA’s acceptable intake limits, resulting in a new recall for certain versions of that drug, as well as an expansion of a recall already underway.
NMBA is the third such impurity found in large numbers of generic ARB drugs since the first valsartan recalls were issued in July 2018, when it was discovered that much of the generic valsartan supply in the United States has been contaminated with chemical by-products for years, known as N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which all known to increase the risk of cancer among humans.
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, 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. That said, any presence of such impurities in drug products is not acceptable,” FDA Commissioner Scott Gottlieb said in the press release. “Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients.”
On February 28, the FDA announced a Camber Pharmaceuticals losartan recall due to the presence of NMBA. Camber indicates that there have been no reports of adverse events linked to the recalled tablets.
The recall affects 87 lots of losartan potassium tablets, USP manufactured by Hetero Labs in India packaged in 30, 90, 500 and 1,000-count bottles at 25 mg, 50 mg and 100 mg strengths. The full list of affected lots is published in the recall notice.
Consumers with questions regarding the Camber Pharmaceuticals recall can call Camber Pharmaceuticals’ Med Line at 1-866-495-1995.
Additionally, on March 1, Torrent Pharmaceuticals expanded a recall of losartan and losartan and hydrochlorothiazide tablets to include 114 lots overall. Again, there are no reports of adverse events linked to the recalled tablets.
The recall affects 60 lots of losartan potassium tablets USP, and 54 lots of losartan potassium/hydrochlorothiazide tablets, USP. These were also manufactured by Hetero Labs.
Consumers with questions regarding the Torrent Pharmaceuticals recall can call 1-800-912-9561 or send an email to Medinfo.Torrent@apcerls.com.
The FDA indicates that it will add NMBA to impurities it will look for in losartan, valsartan and other hypertension drugs. The agency has updated the list of recalled valsartan and similar drugs.
Other Valsartan Recalls Continue
In addition to the two NMBA recalls, the FDA announced an AurobindoPharma amlodipine valsartan tablet and valsartan tablet recall expansion, affecting 38 lots due to the detection of NDEA. The recall affects 30 and 90 count bottles. A full list of affected lots is listed in the recall notice.
Consumers with questions about the AurobindoPharma recall can call 1-866-850-2876 and select Option 2. They can also send an email to email@example.com.
The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to firstname.lastname@example.org.
The FDA requests that patients and healthcare professionals report any problems or adverse events linked to these medications to its MedWatch adverse event reporting system.
In addition to the recalls, plaintiffs nationwide are filing a growing number of valsartan lawsuits over claims of liver cancer, stomach cancer, kidney cancer, colorectal cancer and other cancers allegedly caused by years of taking tainted valsartan and other hypertension drugs. There are also a number of valsartan class action lawsuits pursuing damages for users of the medications who have not been diagnosed with cancer, seeking reimbursement for the cost of what were essentially worthless drugs, and funding for medical monitoring they may require for the rest of their lives due to their exposure to cancer-causing agents.