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Zantac is a brand name its generic name is Ranitidine.NDMA or N-nitrosodimethylamine is a potential cancerogenic product. Last year there were several recalls of NDMA contaminated Valsartan and related API’s in the sartan-family. The reason for the contamination was a change in the manufacturing process of some generic manufacturers (see e.g. Kurt Van den Broeck's answer to What would cause NDMA contamination in valsartan?. for more details)The more recent NDMA contamination in Zantac more or less emerged from the Valsartan case. Due to the issue, other API’s were tested for this type of cancerogenic impurities. And one of the drugs that became under the attention was Zantac.To date, it is actually not crystal clear if the problem originates from an issue in manufacturing or an issue with testing or the instability or degradation of the product.Maybe a brief course of eventsOn September 9, 2019, a so-called citizen Petition was forwarded to the FDA by Valisure (available as a pdf download).In this petition Valisure claims that when applying the same testing method that was used to test NDMA content in the Sartan family it gave unexpected high values of NMDA. The method involves GC and during the injection, NDMA might come from degradation. Indeed ranitidine has a nitrite function at one end of the molecule and a dimethylamine function at the other end.But even if the method is adjusted to lower temperatures ranitidine was found to contain NDMA.(there is a lot more info in that document but I will come back to that)On September 13, the FDA issued a Statement alerting patients and health care professionals of NDMA found in samples of ranitidine.On September 18, Sandoz, a division of Novartis AG, announced that it stops Distribution of Zantac. as a precautionary measure.On September 19: Some countries in the European Union are recalling ranitidine containing an active ingredient made by an India-based manufacturer, Saraca Laboratories Ltd, said Germany’s Federal Institute for Drugs and Medical Devices in a statement.Dr. Reddy’s Laboratories Ltd., announced on September 20 that they were also suspending distribution as a precautionary measure.On September 24 the FDA announces voluntary recall of 14 lots of Sandoz ranitidine capsules following detection of an impurity.On September 26 the FDA announced the voluntary recall of NDMA in Zantac (ranitidine) manufactured by Apotex Corp.On Oktober 2 the FDA provides an update on testing of ranitidine for NDMA impurities. They recommend using an LC-HRMS method (so not GC, in order to prevent the formation of NDMA during testing.So the info available today (Oktober 3) is preliminary: the investigation is still ongoing and it is not clear why there is NMDA in Ranitidine.I had a hard time to find actual published values of the NDMA content, this might be due to the fact that the analytical method was not available to all the laboratories. Or because the results vary too much when repeated by another lab.The only values are from Valisure (see the above citizen Petition)So about 3 mg of NDMA in a 150 mg tablet of Ranitidine. Comparing to the daily acceptable intake limit on NDMA in pharmaceuticals of 96 nanograms (as recommended by the FDA) this is a factor of 30 000 more than the recommended maximum.But these were using the original method (so at 130°C) so these are related to degradation during the testing.But in the citizen Petition, Valisure highlights that ranitidine in the presence of nitrite and stomach conditions will form NDMA anyhow regardless if it was present in the tablet or not. Valisure did some testing themselves using a simulated gastric fluid and added sodium nitrite (which is present in some food and produced by certain bacteria) when they added 25mM sodium nitrite they could detect 23,600 ng per tablet of NDMA. Although a 25 mM sodium nitrite solution seems high, they also refer to other published results.A 2016 article (Link) found ~400-fold increase in the urinary NDMA concentrations upon ranitidine consumption suggesting the additional formation of NDMA from ranitidine within the body.This scheme is taken from that article giving a possible pathway from Ranitidine to NDMATo conclude: the investigation is still ongoing. It is not clear what the true nature of the problem is.It might be due to the testing method, it might be due to manufacturing issues. But since the issue seems to be not related to one manufacturer it might have been there since the product was first brought to market.In addition, based on the 2016 article, my advice as a chemist (I’m not a medical expert, nor a toxicologist) is to avoid Zantac for the time being and ask your doctor for an alternative especially if you are using it for a long period.Nothing we do in human society is without risk: the original manufacturer GSK did investigate NMDA content (Effects of one year's treatment with ranitidine and of truncal vagotomy on gastric contents) in 1986. But this study could not find any correlation between NMDA content in the urine and ranitidine treatment. This might be due to differences in analytical methodology. So although current info might suggest that there is a serious risk. Health authorities can only act upon the information that is available.I’m sure FDA and other medical agencies will investigate this more thoroughly and will take the necessary actions.As always they need to balance the risks against the benefitsTo be continued.EDIT: I updated and corrected this post on October 5. The tabulated data of 3mg per tablet were due to the degradation of the samples during testing.

High blood pressureIn the US high blood pressure causes 348,000 American deaths per year, in the world its death toll amounted to 9.4 million every year. This is unfortunate as high blood pressure is an illness, which can both be effectively treated and prevented. Uncontrolled high blood pressure (hypertension) causes heart attacks and strokes, can cause kidney failure, heart failure and blindness. You control blood pressure with lifestyle changes and/or medication, and these risks go away.The age standardized death rate (Ref. 1) for both sexes in the US for heart disease is 80.5 per 100,000 and for strokes 25.4. In Canada these rates are 66.2 and 22.9; in Germany 75.0 and 31.2; in Italy 51.7 and 34.9, in Japan 31.2 and 36.7. The death rates from cardiovascular disease per 100,000 people in the same countries is as follows: in the US 172.2, in Canada 130.7, in Germany 200.2, in Italy 153.5 and in Japan 107.1.There are obviously significant differences in these countries, which I will discuss further below.On the occasion of the World Health Day, which was celebrated on 7 April 2013 to commemorate the founding of the WHO in 1948, with the topic of high blood pressure the World Health Organization has edited a PDF publication of 155 pages entitled “Global Atlas on cardiovascular disease prevention and control” (Ref.1, be patient, loads slowly). In it prevention and treatment for high blood pressure are discussed in detail. This text points out that there has been a remarkable decline in death rates from heart attacks and strokes (collectively called “cardiovascular disease”) between 1981 and 2000 in the United Kingdom. A thorough analysis of this showed that 58% of this decline was due to risk factor reduction in the whole population (reduction of smoking and heavy alcohol consumption, reduced salt intake, combatting physical inactivity and reduction of saturated fat intake). The other 42% of the decline in cardiovascular disease is due to treatment by a physician. So, it is clear from this that the majority of mortality prevention comes from the patient, less than 50% comes from the treating physician. However, it is important that physicians will educate their patients to cut out risk factors themselves in order to prevent hypertension.Risk Factors for High Blood PressureIn the past it was thought that most cases of high blood pressure would be due to “essential hypertension”, a term saying “we don’t know what causes high blood pressure”. Many physicians still use this term. Only a small amount of cases were considered “secondary” hypertension where the causes were known (e.g. kidney disease, hormonal imbalance, pregnancy). But in the meantime research by Harvard University and other research institutions has shown that there are a number of specific causes that contribute to high blood pressure, either alone or in combination.Here are the commonly known causes: too much salt in our diet; we tend to not eat enough vegetables and salads; we like to sit in cars, in front of the TV or in front of the computer (physical inactivity). Many people still smoke, although tobacco is known to cause high blood pressure and lung cancer. Too much alcohol is known to cause hypertension as well. So the following steps will prevent high blood pressure :consuming less salteating a balanced diet (preferably the DASH diet)engaging in regular physical activityavoiding tobacco useavoiding harmful use of alcohol (more than 2 oz. or 60 Grams per day)Diabetes is known to worsen the risk for heart attacks and strokes and increases the risk of high blood pressure as well. So, some hidden risk factors for high blood pressure related to diabetes are as follows: a high fasting blood sugar; obesity; food with too much fat, too much sugar and too many starches (not enough complex carbohydrates).What Can Be Done To Reduce Death Rates From High Blood Pressure?As Canada is one of the countries where the death rate from strokes and heart attacks is lower than in the US or Germany, I like to point out some of the reasons for this. I practiced medicine in Canada for many years. The “Canadian Hypertension Education Program” have been guidelines for practicing physicians to follow providing effective screening and treatment of high blood pressure. Cardiologists at various continuing education conferences have promoted this. At my office I had a hypertension recall program where my staff called every patient with high blood pressure into the office every 3 months. We would review the home-measured blood pressure readings from the patient (recorded in a little booklet). I also took the blood pressure of the patient and so did my staff on the patient’s arrival. We reviewed the blood pressure medication and reviewed the possible side effects. The patient was also told what to do, if the blood pressure would be higher than normal (possible adjustments of the medication at home). I also encouraged my patients with regard to the life style issues (the 5 points mentioned above). Over the years the number of patients who developed heart attacks or strokes declined, as one would expect.A recent review in the Canadian Family Physician mentions that there is room for improvement regarding the Canadian statistics. As mentioned above Italy and Japan are doing better with regard to mortality from heart attacks and strokes compared to Canada. We have a health care system in Canada that is available to every Canadian resident and funded by provincial taxes. In this system patients do not have to pay for office visits (although they pay for it indirectly through taxes). For the patient with high blood pressure it means that there is a system in place, which helps prevent cardiovascular disease and treats high blood pressure effectively. In my opinion the home recording of self-measured blood pressure readings at least once per day with a home blood measure monitor is vital to encourage the patient to be engaged with regard to his/her blood pressure problem.Newer Findings About High Blood PressureFor years physicians did not know where high blood pressure came from. In the last few years research has shown that nitric oxide plays an important role in preventing high blood pressure. It is produced by the lining of your arteries (by the so-called “endothelial cells”) and is the natural artery relaxer.Foods that produce nitric oxide in the body are spinach, kale, red beet, cabbage varieties and other vegetable greens. These foods, which are also contained in the DASH diet, and regular exercise will stimulate the lining of your arteries to produce nitric oxide, which prevents high blood pressure, heart attacks and strokes. If all these measures and the above recommendations to prevent high blood pressure do not help, it is time to treat it. As already indicated above it is important that the patient who has been identified as needing high blood pressure treatment with medication, takes the medicine regularly (called ”compliance”). By keeping the blood pressure reading below 120/80 you prevent your risk of getting a heart attack, a stroke, heart failure or blindness from broken retinal vessels. If the patient develops any side effect from the medication, it is important to see the physician about this right away. It may be that the medication has to be adjusted or altered.Nitric oxide can be taken as a supplement (Neo40), which allows the endothelial lining to be regenerated as indicated in this interview with the inventor, Dr. Nathan Bryan from the University of Texas Health Center in Houston.The older we are, the more likely it is that our blood pressure will be high. As this link shows, 2 out of 3 people above the age of 60 in the US have systolic hypertension (the upper value of the blood pressure is elevated). As we age, it appears that the lining of the arteries do no longer produce the required amount of NO (nitric oxide) to prevent high blood pressure and prevent hardening of the arteries. So, it would be wise to adopt the Mediterranean diet with lots of vegetables, spinach, kale, bok choy, Swiss chard and others to boost your NO production, but still measure your blood pressure regularly. If you do not have a home blood pressure monitor, go to a pharmacy that allows you to check your blood pressure for free. If it is above 120 over 80 seek the advice of a health professional. You can find more information in Ref. 1.In essence, what World Health Day 2013 asks us to do is to pay attention to your blood pressure and make sure it is normal.This was previously published here: World Health Day 2013, Focus on Hypertension - Medical Articles by Dr. RayMore on high blood pressure: High Blood Pressure - Net Health Book