Like a tropical storm that morphs into a category 5 hurricane, the lack of oversight that resulted from the recent blood pressure drug recall has exploded into a potential catastrophe.
What began as a recall of just one drug because of contamination could be brewing up a whole new era of alarm over meds that can do more harm than good.
Earlier this summer, I told you about the recall of a widely prescribed generic blood pressure drug called valsartan, one that docs write an Rx for over 16 million times a year.
In fact, if you’re taking a drug for hypertension, there’s a very good chance that it contains valsartan.
At first, the danger was said to include only five different products made in China for three manufacturers. Those drugs were found to be tainted with a carcinogenic chemical called NDMA (which is used to make rocket fuel!) that’s been linked to liver and kidney cancer and known to be dangerous “at very low levels.”
That was bad enough.
But fast-forward to the end of August, when the FDA announced that it would also be looking into “all the products in the ARB class to determine if they contain NDMA.”
ARBs represent a big lineup of angiotensin II receptor blockers, which are used to treat high blood pressure, heart and kidney failure, and chronic kidney disease.
And instead of calling NDMA a carcinogen, toxin, or even a chemical, the FDA prefers to label it as an “impurity” that simply doesn’t meet the agency’s “safety standards.”
It’s as though we’re talking about a little piece of eggshell that fell into an omelet!
Regardless of how the feds care to downplay the risk with fancy terminology, however, their actions show how serious the matter actually is: The FDA has established a dedicated task force of chemists, toxicologists, doctors, pharmacists, and an entire lab staff to investigate the possible risk coming from this huge class of drugs.
And that means that more urgent recalls could be on the horizon.
This task force even had to develop a special test to be able to identify the rocket-fuel chemical!
But you can bet that this is far from the only “impurity” that it should be looking for. And since the group didn’t even have a test at the ready to detect NDMA, we may never find out what other hidden toxins are present in these drug imports.
The current rationale about how this disaster could have occurred places the blame on Chinese manufacturers – although the FDA admits that it’s not “100 percent sure” that’s the whole story.
But if there is one thing we are completely and totally sure about, it’s that this nightmare is just the tip of a deadly iceberg when it comes to the foreign-made pharmaceuticals imported into the U.S.
Practically all of the drugs you can think of — from statins to arthritis meds to antidepressants and all of our antibiotics — are made in China. And many others are manufactured in India, where FDA inspectors have found conditions so horrific that they barred some plants from sending us drugs!
Along with the original recall involving valsartan meds from drugmakers Major Pharmaceuticals, Solco Healthcare, and Teva, this special FDA task force is currently investigating a long lineup of generic ARBs.
What’s now going on tells us one thing loud and clear: Big Pharma’s risky products should only be used as last resorts, not first-line attempts to solve a health problem.
That’s why this is as good a time as ever for a get-together with your doctor to reevaluate any Rx meds you’re taking. Because you can assume that whatever it’s for, that pill was made in some faraway place without FDA control.
As for finding out if one of these adulterated atrocities is in your medicine cabinet, however, you may have to go online… as this new list is as long as your arm.
“FDA investigation into heart drug valsartan may lead to more recalls” Jen Christensen, August 30, 2018, CNN, cnn.com