Experts say the contamination lies in the manufacturing process. But don’t panic if you take these particular types of pills.
Another day, another blood pressure medication recall.
That’s the way it’s seemed for almost the past year.
The latest installment comes in the form of a petition to the Food and Drug Administration (FDA) by the online pharmacy Valisure.
The company says certain lots of the generic blood pressure and heart medication valsartan is contaminated with dimethylformamide (DMF), a known cancer-causing chemical, CBS News reported.
Should the FDA agree with Valisure’s recommendation to lower acceptable levels of DMF in heart medication and recall those containing high levels of DMF, it would add to the growing list of generic and name-brand versions of the drug that have been recalled in the past year.
Since July 2018, more than 400 lots of a class of heart and hypertension drugs known as angiotensin receptor blockers (ARBs) have been recalled for potential contamination with cancer-causing chemicals. That list includes valsartan, losartan, olmesartan, and irbesartan.
Previous recalls have centered on contamination by several other classes of carcinogens, including N-nitrosodiethylamine (NDEA), N-methyl nitroso butyric acid (NMBA), and N-nitrosodimethylamine (NDMA).
Because of this, the FDA announced in March that it would fast-track the approval of new valsartan products to help make up for any gaps in availability.
The recalls create two important questions for consumers.
How did all this happen?
And what should I do if I take these medications?
This might all sound pretty dire, but doctors and health safety experts say there’s no reason to worry — yet.
“The recall only covers ARBs made at specific factories,” Dr. Christopher Kelly and Dr. Marc Eisenberg, two cardiologists who have written a book together, told Healthline. “These same medications are safe if the pills were manufactured elsewhere.”
The best course of action if you take one of these drugs is to take your pill bottles to your pharmacist and find out if you’ve been taking drugs from one of the recalled lots, the doctors say.
Your pharmacist should be able to replace them with a safe version of the medication from a different manufacturer.
The FDA also has an
But what if you’ve already been taking drugs from a tainted lot? Even that isn’t much of a problem, Eisenberg and Kelly told Healthline.
“The risk of cancer resulting from a taking a week or two of these pills is unknown but likely extremely small,” they said in an email. “Therefore, patients taking ARBs who are concerned about possible contamination should NOT stop taking their pills before consulting with a pharmacist or doctor.”
To understand why there have been waves of recalls of this specific type of blood pressure drug, it helps to understand how the drug manufacturing process works.
In the case of many drugs, both name brand and generic, the active pharmaceutical ingredients (APIs) — the stuff that makes drugs work — are manufactured en masse in a handful of factories before being distributed to pharmaceutical companies.
Those companies then mix these APIs into their own formulations of the drug in pills, gel tabs, and other forms.
“So, here’s the problem,” said Dr. David Belk, a specialist in internal medicine and founder of the consumer advocacy website The True Cost of Healthcare. “The FDA only monitors the final product that is made by the pharmaceutical company and not the production of the API that goes into these products.
“Also, multiple generic pharmaceutical companies will buy all of their API supply for each drug from the same manufacturer, usually in batches meant to produce several weeks of supply for each medication. That means that, if there’s a problem with the production of a single batch of an API, it can ruin the whole U.S. supply of that drug for several weeks,” he said.
The phenomenon Belk describes likely explains much of what’s been happening with these drug recalls, although on the timeline of nearly a full year, rather than a few weeks.
So, why has this particular wave of recalls been so severe?
“It’s a domino effect,” Dr. Satjit Bhusri, a cardiologist at Lenox Hill Hospital in New York, told Healthline. “Once impurity from one manufacturer is found to be carcinogenic, the whole family of medications is checked.”
What started with losartan and NDMA contamination has snowballed into the current recall trend as each medication has been checked successively for contaminants.
While Belk would argue the FDA is too reactive in its role in mitigating these drug recalls, other doctors cut the agency more slack.
“The FDA took all appropriate steps once the impurity was identified, [and] they notified the patient, physician, and pharmacist to be aware of any recalls,” Bhusri said.
Dr. Robert Greenfield, medical director of noninvasive cardiology and cardiac rehabilitation at MemorialCare Heart & Vascular Institute at Orange Coast Medical Center in California, has even stronger praise for the agency.
“The FDA tests well, and we would all be in great danger if it wasn’t for the FDA,” he told Healthline. “So as consumers, one can make sure that the information they are reading is from a website that is reliable, call their pharmacist, or visit the FDA website and learn about their quality control.”
Dr. Sanjiv Patel, another cardiologist at MemorialCare, agrees with his colleague, although he notes some room for improvement.
“Likely, more facility visits and drug sample checks are needed,” he told Healthline. “The FDA normally and routinely does just that, and with these recent rash of recalls, I am confident that the FDA will continue to allocate the necessary resources to ensure further recalls now and in the future.”