It’s like déjà vu all over again. The U.S. Food and Drug Administration (FDA) has just announced yet another blood pressure medication recall due to unacceptably high levels of an impurity. This time it’s Lupin Pharmaceuticals Inc. that’s issued a voluntary recall. They’re recalling all batches of their irbesartan tablets as well as their irbesartan plus hydrochlorothiazide (HCTZ) tablets. The impurity of concern is N-nitrosoirbesartan, which has been deemed a “probable carcinogen” or something that may cause cancer.
If you are wondering where you may have heard this story before, just think back to 2019. That was before the Covid-19 pandemic, before people started treating toilet paper like “my precious.” Back then blood-pressure-medication-recalls-for-possible-cancer-causing-impurity announcements had seemingly become like the Halloween movie franchise. The bad sequels kept coming and coming with the same recurring plot. For example, in 2019 alone, I wrote three separate articles for Forbes on three different blood pressure medication recalls in January, March, and November of that year. In fact, in the January 2019 article, I asked, “can you recall a year with more blood pressure medication recalls than 2018?” Each time the manufacturer may have changed but the song remained the same: some type of contaminant had reached unacceptable levels.
Angiotensin II receptor blockers (ARB) have been the subject of recalls in the past. In fact, irbesartan specifically has as well. Irbesartan may sound like the group that sang “Black Hole Sun.” But that would be Soundgarden. Instead, irbesartan is an ARB. Angiotensin II is a substance that cause blood vessels to narrow. So blocking receptors for this substance in turn can lead to the widening of blood vessels, which can lower blood pressure.
The irbesartan plus HCTZ tablet combines another blood pressure medication that works via a different mechanism with irbesartan. HCTZ is a diuretic, which means that it makes you pee more. Doctors don’t prescribe this medication just to mess with you. Peeing more can help get rid of excess salt and fluid from your body, which, in turn, can reduce your blood pressure in a different manner.
Lupin is certainly not the only company to make and distribute irbesartan-containing products. Don’t automatically assume that your irbesartan is affected by the recall. Check your package. No, not that kind of package, but the package that the medication came in when you purchased it. Take a look at the label on the bottle as well. If you still can’t tell who made your medication, call your pharmacist. Lupin had already discontinued in January 2021 the marketing both irbesartan alone and irbesartan plus HCTZ. Nevertheless, such tablets are still out there. Therefore, Lupin is recalling all tablets that may have been shipped from October 8, 2018, to September 30, 2021.
Now, typically, when something is called an impurity, it doesn’t mean that there are massive amounts of the stuff. So you probably don’t have scoopfuls of N-nitrosoirbesartan in the recalled products. Such an impurity is unlikely to cause cancer simply by putting a single irbesartan tablet in your mouth. It’s not like swallowing the Reality Stone. Instead, such an impurity may become a problem when you ingest it repeatedly over time. So, the recall doesn’t necessarily mean stop your irbesartan or irbesartan plus HCTZ immediately. Talk to your doctor first.
If you don’t have a doctor, yet are taking one of these prescription medications for blood pressure, ask yourself, “how the heck did that happen?” After all, you typically need a doctor to prescribe such a medication. And talk to a real doctor as soon as possible.
Why have these recalls been happening so frequently? One has to wonder whether medication safety regulations have become too loose. Loosening regulations was one of the stated goals of former U.S. President and current Mar-A-Lago resident Donald Trump. Loosening regulations may sound great if you are trying design or sell stuff. But many regulations are in place to protect the public from products that may be fraudulent, ineffective, or unsafe. When it comes to drug safety, loosening regulations can be like loosening underwear. Things can really slip out and, in turn, cause problems.
These blood pressure medication recalls are not simply a one-time occurrence or even a two-time occurrence. As they say, once can be an accident. Two times can be a coincidence. Three times is a trend. And four times or more is a “dude, didn’t you notice that there was a trend.” Therefore, it may be time to recall all the recalls that have happened over the past several years, and determine what systems need to be changed.