By Bruce Y. Lee, Forbes
You may want an MBA. But you want to avoid NMBA.
NMBA stands for N-Methylnitrosobutyric acid, something that you don’t want in your blood pressure medications. But alas, this probable carcinogen continues to appear in various medications at higher than acceptable levels.
The latest news is that Torrent Pharmaceuticals Limited is further expanding its recall of Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, according to the U.S. Food and Drug Administration (FDA). The FDA announcement includes five more lots of these medications. The additional lots add to the lots of blood pressure medications that have been recalled in the past 14 months or so.
In 2018 and 2019, it has seemed like news about potential cancer-causing contaminants in medications has become as repetitive as the lyrics “My Name Is” in Eminem’s song “My Name Is.” I’ve written about such news for blood pressure medications in November of last year, January of this year, and again March of this year. Then, just last week I covered impurities found in a common heartburn medication, ranitidine. Then, on Thursday, I added an update that Novartis was halting its distribution of ranitidine, the generic form of Zantac, until further testing could be done.
If you happen to be taking one of these medications, don’t panic. As I have mentioned before, panic is rarely helpful outside the disco. Plus, while the levels of potential carcinogens may be above acceptable thresholds in many of these medications, for the most part, they still seem to be very low. Short-term exposure to chemicals like NBMA, N-nitrosodimethylamine (NDMA), and N-nitrosodiethylamine (NDEA) at such levels may not have any bad health effects. Such chemicals can already be found as contaminants in many parts of our environment. Keep in mind, though, that studies on the impact of such chemicals on human health are limited so minimizing exposure to them in general is a good idea. Moreover, these incidents do raise bigger questions.
As they say when you soil your pants, one time may be an accident but more than three times is a trend. It is time to take a closer look at how drugs are being manufactured, stored, and distributed and how such processes are being monitored. Making medications is not the same as making handbags. You don’t, at least you shouldn’t, eat your handbags. While a poorly-made handbag could lead to social embarrassment, a poorly-made medication can have much greater and even life-threatening implications. The FDA is the main agency to protect you against fraudulent and contaminated medications. But the FDA currently may not have the funding and the resources to carefully check everything that every drug manufacturer and distributor is doing, especially when some of these operations are rapidly changing or occurring overseas.
For example in this Bloomberg News segment Bloomberg reporter Anna Edney says that the FDA is testing less than 1% of drugs that cross the border and are otherwise relying on the industry to self-police:
The segment shows a graph indicating that FDA surveillance inspections of overseas drug manufacturers have actually gone down since 2016. In fact, the graph provided below in Edney’s tweet shows that inspections of U.S. drugmaking facilities have been trending downwards as well:
More generics help @realDonaldTrump rack up wins in his drive to lower Rx prices
But data integrity issues are popping up at drug-manufacturing factories worldwide and the FDA is doing fewer surveillance inspections of those factories https://t.co/dh8JsWKQ1g pic.twitter.com/fDJSG2Aq6g
— Anna Edney (@annaedney) January 29, 2019
You don’t need a ruler to see that these lines are going the wrong direction.
For now, if you are taking blood pressure medications, or any medications for that matter, pay attention to FDA warnings and recall news. The FDA maintains a searchable listing of active product warnings and recalls. As a precautionary measure, before starting any medication, you may want to search for it in this FDA site. You can also check with your pharmacist to make sure that your medication is not on a recall or warning list.
Of course, if you do find that your medication has a warning or is being recalled, don’t just stop taking it. That can be like trying to return a parachute while you are using it. Check with your doctor first to determine your course of action.
This article originally appeared in Forbes.