A national effort to recall carcinogen-tainted batches of the popular blood pressure drug losartan has once again expanded, growing to include one lot of the medication distributed by Legacy Pharmaceutical Packaging, LLC.
Legacy’s April 24 announcement comes on the heels of a mass voluntary recall of losartan a week ago—104 lots managed by Torrent Pharmaceuticals Limited. Both Legacy and Torrent distributed losartan manufactured at the same API facility in India, Hetero Labs Limited.
The latest voluntary recall of one lot of 50 mg losartan tablets adds to Legacy’s existing consumer-level recall of three repackaged lots of the drug due to the detection of trace amounts of N-methylnitrosobutric acid (NMBA), a probable human carcinogen. It’s the latest in a chain of recalls dating back to last November, when distributors started finding unacceptable levels of possible carcinogens in certain lots of the ARB (angiotensin II receptor blocker) drugs losartan, valsartan and irbesartan.
To date, Camber Pharmaceuticals, Inc., has issued a recall of 87 lots of losartan; Torrent has recalled 234 lots and Legacy has recalled 4 lots. In the United Arab Emirates, the Ministry of Health and Prevention is attempting to withdraw losartan from its market entirely due to evidence of N-nitrosodiethylamine (NDEA) in the drugs.
There’s been significant legal fallout in the U.S., too. According to Bloomberg, “dozens” of lawsuits have already been filed against drug makers and sellers who prescribed tainted ARBs. Daniel Nigh, an attorney who’s filed 12 such lawsuits already, told a federal court he expects around 2,000 more personal-injury cases in the next two years.
The primary target of existing lawsuits is Zhejiang Huahai Pharmaceutical Co., Bloomberg reported—a drugmaker responsible for distributing contaminated valsartan that was then used as a BP drug and as a component of other cardiovascular therapies. But giants like CVS, Teva Pharmaceutical Industries and Mylan NV have also been named in suits, with almost 40 defendants sued so far.
“There’s a number of people who claim, I understand, that they’ve contracted cancer from taking this drug,” Senior U.S. District Judge Robert Kugler told Nigh and other lawyers at a March 27 hearing. “It’s probably going to be a heavy lift to prove that, but, you know, we’ll see what happens.”
For more coverage of recent ARB recalls, see below: