Possible consequence of Trump’s trade war with China
IN July 2018, the Food and Drug Administration (FDA) of the United States announced a recall of the anti-hypertensive angiotensin receptor blocker (ARB) valsartan because of contamination with a cancer-causing nitrosamine, N-nitrosodimethylamine (NDMA).
Initially affecting only one Chinese factory, the recall was then expanded and emulated by other regulatory bodies on companies and factories all over the world.
In March 2019, the Singapore Health Ministry estimated that 137,000 patients have been affected by the recall. The Malaysian deputy health minister has had to issue a public call to advise patients not to panic over the issue.
The list of drugs recalled by the USFDA now extends to over 1,090 entries.
The chemical contaminant at the heart of the problem is also found in food, especially processed meats, milk and fish. The FDA mandates that maximum intake of NDMA from the ARB drugs should not exceed 96ng (nanogram)/day.
Yet, the NDMA level in meat products can be as high as 370ng/kg, up to 700ng/kg in milk and 820ng/kg in fish. Canadian beer was reported to contain up to 590ng/litre of NDMA, while beer imported into Canada contained up to 3,200ng/litre of NDMA.
NDMA level can be up to 76ng per cigarette while environmental tobacco smoke can expose an adult to up to 50ng/kg per day of NDMA.
Near a rocket engine testing site, ground water was found to contain 400,000ng/litre of NDMA. Thus, food, beverages, groundwater and atmospheric exposure to NDMA can be far in excess of the amount contained in hypertensive drugs.
In October 2018, the recall was extended because of another nitrosamine, N-Nitrosodiethylamine (NDEA). In March 2019, a third cancer-causing contaminant, N-Nitroso-N-methyl4-aminobutyric acid (NMBA) was identified, resulting in more ARB recalls.
Such is the disruption to the anti-hypertensive drug supply that on March 30, 2019, the FDA had to raise its own limit for acceptable NMBA level by over 10 times, from 0.96ppm (parts per million) to 9.82ppm. But until today, the FDA still does not limit individual nitrosamine levels in beverages and food products.
Excluding environmental tobacco smoke, estimates of daily exposure to NDMA reach 16ng/kg body weight for adults while smoking can expose a person to up to 17,000ng per day of nitrosamine.
Hypertension is asymptomatic and the aim of treatment is to motivate patients to take medication to prevent future stroke, heart and kidney disease.
Many patients do not take medication either because they do not see the need for it when they feel well or they fear the side effects. Now that the cancer-causing potential of hypertensive drugs has been so widely publicised, many will be even more fearful.
But the truth is that the nitrosamines NDMA, NDEA and NMBA are widespread environmental contaminants and till July 2018, at the start of President Donald Trump’s trade war with other countries, were not previously monitored by the FDA in pharmaceutical products.
Even today, the FDA has not set limits for these agents in beer, meat or cigarettes.
There is a need to highlight the widespread prevalence of these nitrosamine contaminants and the very small amounts found in antihypertensive drugs compared to other sources so that patients can continue to be motivated to take their medicine.
Hypertension is asymptomatic and the aim of treatment is to motivate patients to take medication to prevent future stroke, heart and kidney disease.