Dozens of blood pressure medicines have been recalled. The medications, containing an ingredient used to make rocket fuel, are the latest in the recent mass blood pressure drug exodus.
The recent recall that follows months of blood pressure drug recalls may be an ominous sign for modern medicine as the blood pressure and stroke medications are manufactured in China, notorious for its pollution. Two-thirds of the ingredients from the drugs originate in China, whereas the other third comes from India.
These are the blood pressure medications that are most affected by the recall.
The medications most affected by the recall are valsartan, valsartan, and hydrochlorothiazide tablets, and amlodipine and valsartan tablets. The UK reports a recall affecting irbesartan hydrochlorothiazide tablets made by Actavis pharmaceutical company.
ABC7 News reports on the latest recall:
Aurobindo Pharma USA, Inc., has issued another voluntary recall of medications used to treat high blood pressure and heart failure due to the possible presence of a cancer-causing substance in the pills.
The company said 80 lots are affected: two lots of Valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets.
Last year, ScieGen Pharmaceuticals, Inc and Aurobindo Pharma Limited of India had a simultaneous recall for Irbesartan along side due to contamination fears.
The FDA announced that the latest slew of blood pressure medicine recalls was “due to the detection of trace amounts of an unexpected impurity found in the finished drug product.”
The ingredient? A highly controversial contaminant that brings up many questions about the safety of modern medicine.
Why are the blood pressure drugs being recalled?
The medicines in question contain NDMA, once used to make rocket fuel and considered probably carcinogenic to humans according to the International Agency for Research on Cancer; and NDEA, still used in the manufacture of rocket fuel.
In each case, a recalled drug was contaminated with either N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA).
NDEA is used to make rocket fuel and can also be found in some food and drinking water, but at low levels. It can also be a created through certain chemical reactions and as a byproduct of industrial processes.
The gist of the blood pressure medication recalls
“Almost 60 million prescriptions were written for losartan drugs in 2016 and 14 million for valsartan or a drug that includes it. Another 3.6 million prescriptions were written for irbesartan that year,” says WebMD.
Valsartan – There are so many recalls for this drug that the FDA has a special website listing just for valsartan.
Irbesartan – July saw a voluntary recall of irbesartan tablets. See list of all products affected by the recall.
Losartan – Losartan potassium tablets USP were voluntarily recalled in December 2018. List of all losartan products affected by recall. Also, FDA announced a November voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.
Which specific drugs are affected?
Anyone taking valsartan should check the following reports. The medicine is used to treat hypertension, heart failure and for reducing the risk of death after a heart attack.
Here is a PDF from the FDA and a most recent announcement displaying all the recalled drugs and their distribution dates. Too many to list here, but see below for some bullet points.
Earlier in December, US News reported:
Over the past few months, numerous recalls of the popular heart drug valsartan have already occurred. Now, generics maker Mylan Pharmaceuticals is adding more products to the list.
The recall involves 104 lots of three medicines: valsartan tablets; combination tablets with the drugs valsartan and amlodipine; and combination tablets with valsartan and hydrochlorothiazide.
The reason for the move is similar to that cited in prior valsartan recalls: Mylan said it had detected trace amounts of a probable cancer-causing chemical called N-nitrosodiethylamine (NDEA) in valsartan meds.
That recall included these medicines distributed between March 2017 and November 2018:
- 26 lots of amlodipine and valsartan tablets, USP (5 mg/160 mg; 10 mg/160 mg; 5 mg/320 mg; and 10 mg/320 mg)
- 51 lots of valsartan tablets, USP (40 mg, 80 mg, 160 mg and 320 mg)
- 27 lots of valsartan and hydrochlorothiazide tablets, USP (80 mg/12.5 mg; 160 mg/12.5 mg; 160 mg/25 mg; 320 mg/12.5 mg; and 320 mg/25 mg)
Made (outside) the USA
NDEA is also a substance that shows up in air pollution; recalled medicines were prescribed for four years before the problem was detected.
The FDA’s Janet Woodcock had said,
We still don’t understand the complete root cause of this problem. We understand part of it. We don’t understand all of the steps that led to this.
She said that the factories implicated were placed on “import alert,” however, at the time, she did not disclose where the factories are located. Woodcock also seemed baffled that the recalls are still pouring in despite the import alert, meaning certain distributors must still be using the tablets or ingredients in question.
Yet, other reports have been forthcoming that the factories are located in China and India, which, unfortunately are prone to pollution, breakneck working conditions and lax regulations.
Is this because of global free trade?
Recent reports have certainly revived fears about imports and dread over the potential consequences of global free trade.
Tampa Bay Times reported:
Dr. Harry Lever, a cardiologist at the Cleveland Clinic, said he was concerned about quality control of generic medicines, like valsartan, made in China and India. He believes that manufacturers should be more transparent about where their active ingredients are made.
“It’s not just valsartan,” Dr. Lever said. “It’s becoming very difficult for me to write prescriptions at all. There are so many drugs that are coming in from India and China and companies are buying and selling each other and you don’t know what’s what.”
Creepily, the FDA minimizes the risk of ingesting trace amounts of NDEA and NDMA on a daily basis. According to WebMD, the FDA said:
…if 8,000 people took the highest valsartan dose, which is 320 milligrams, from recalled batches every day for 4 years, there would likely only be one additional case of cancer over the life of those 8,000 people.
For context, 1 in 3 people in the United States will be diagnosed with cancer in their lifetime.
How’s that for assurance?
What can I do about the recall?
If you find out that your medicine is on the recall list, here are some tips.
First, the FDA recommends looking at the manufacturer’s name on the label of prescription bottles to determine if it’s apart of the recall. If no name is on the bottle, contact the pharmacy it came from to find out.
The FDA is recommending that people keep taking their medicine and contact their medical practitioner immediately to switch to an alternative. It may sound like the typical FDA response to assure people to keep taking a drug with a potential harmful ingredient. However, it’s important not to suddenly stop medication and to only transition to a new medicine with a doctor’s help.
Consider medicines and brands that are made in North America or Europe, which has more restrictions on ingredients.
Again, please don’t suddenly discontinue your medicine protocol. Explain the situation to your medical office and immediately seek a doctor’s help.
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