Week after week, month after month, we have been learning about ARB recalls. These angiotensin receptor blockers have been taken by at least two million Americans to control blood pressure or treat heart failure. According to our latest count (subject to change at any moment), over 750 different lots of valsartan, losartan and irbesartan have been recalled. Given that some of these lots involve bottles with 1000 tablets, this likely involves millions and millions of pills. At long last some physicians are speaking up!
Doctors Speak Our Minds!
We’ve been waiting for some time to see some outrage from mainstream medicine. We often feel like we are talking to ourselves when we complain about problems with pharmaceuticals made in foreign countries. Doctors and pharmacists have been strangely silent on this topic.
Now, though, there is an article in the New England Journal of Medicine (March 13, 2019) titled:
These physicians point out that three “impurities” have been identified in ARB products. These nitrosamine impurities are not supposed to be in medicines that millions of people swallow daily. They have led to the ongoing ARB recalls. The authors state:
“These recalls are of growing concern to patients, clinicians, and organizations delivering primary care or complex, multidisciplinary health care, and they highlight several issues related to the readiness of our health systems to respond to drug recalls, trust between patients and providers, uncertain drug-dose equivalences, and the regulation of drug manufacturing in the global marketplace.”
They go on to note in the New England Journal of Medicine (NEJM):
“FDA officials believe that U.S. patients have been ingesting ARBs containing carcinogenic impurities for approximately 4 years…”
Really? “Approximately” four years! So, millions of Americans have been swallowing nitrosamines from their pills every day for at least four years and the FDA did not know about it. We find that unacceptable!
How Would You Know About ARB Recalls?
There is NO organized system in the U.S. to notify patients about recalled pharmaceuticals. The FDA doesn’t do it. The prescribing physician doesn’t do it. The manufacturer doesn’t do it. It’s left up to the pharmacy. But this is far more complicated and confusing than you would imagine. Many people learn about ARB recalls from the news media, newsletters like The People’s Pharmacy, social media or friends.
Once you hear that there has been a problem with certain lot numbers of valsartan or losartan you might think you could check to see if your pills are involved in the ARB recalls. You would likely be out of luck.
If your pharmacist took pills out of a big bottle and put them in a small amber bottle and stuck a label on it, you would have NO WAY of knowing the lot number. Pharmacists rarely, if ever, put lot numbers on the bottles they dispense. Only the original manufacture’s bottle has a lot number.
Let’s say your doctor prescribed valsartan to control your blood pressure or treat your heart failure. Your chain pharmacy may have purchased its valsartan from the Indian company Aurobindo. If you go to the FDA website you might discover that 80 mg valsartan tablets were recalled on March 1, 2019. Here are the lot numbers.
If you were taking 160 mg of valsartan, the following lot numbers were recalled:
What Good Are Lot Numbers with ARB Recalls?
Sadly, this information may do you no good because your amber bottle won’t have lot numbers on the label. Even if you call your pharmacy and ask about your lot number, the pharmacy has no way of actually tracking what it dispensed in your bottle of pills.
In theory, the corporate office of your chain will guestimate that if your valsartan was dispensed in February, 2019 then it might have been in one of those bottles. You will likely get a letter that says something like this:
“This recall was issued because an unexpected impurity was found in these products that may cause health risks that may represent a potential health hazard or safety risk to patients who may be using product affected by this recall.
“Our records show you may have received a prescription for this product recently through your local XXX/pharmacy.”
Please note that the word “may” was used four times in those two sentences. They have no way of knowing the precise lot number you received if the pills were taken out of a big bottle and placed in one of their smaller amber bottles. Don’t believe us? Just check your amber pill bottles and let us know if you can find a lot number anywhere on the label.
The physicians writing in the New England Journal of Medicine go on to point out that:
“The burden of response has fallen to clinicians, pharmacies, and health care systems, most of which lack the infrastructure or resources to respond promptly to patients’ concerns.”
They also note that if a physician switches a patient from one kind of ARB, like valsartan or losartan to a different ARB like candesartan, olmesartan or telmisartan, there will be issues about dosing and side effects. The switch will require extra lab tests and/or visits to the doctor. As the number of ARB recalls mounts, patients keep being notified that they have to switch to another medicine yet again. The NEJM article points out that:
“the requisite additional switches have further undermined patients’ confidence in their clinician, their health care system, the drug supply chain, or all of the above.”
The ARB Recalls have led to Shortages:
So many lots of valsartan, irbesartan and losartan have been removed from the market that there are serious shortages. You can read more about this crisis at this link:
To cope with this growing problem, the FDA has expedited the review of additional ARB products.
This week the agency announced that it had approved a new generic valsartan from Alkem Laboratories Ltd in India. The FDA reports that its evaluation of Alkem’s manufacturing process does not indicate a likelihood of contamination with nitrosamine carcinogens.
It may take weeks for the new valsartan to make it to your pharmacy. In the meantime, what are you doing about the ARB recalls? Share your experience in the comment section below. Have you lost faith in your pharmacy, the FDA or foreign manufacturers? We value your opinion.