ARB recall: What to do is more than ARBitrary

ARB recall: What to do is more than ARBitrary

Sometimes decisions can be arbitrary. But not with the ARB recalls.

Many things in life are arbitrary. Do you turn left or right, buy this brand-name frozen pizza or a house brand? Sometimes it’s like flipping a coin. But with medication recalls for something such as ARBs, it’s not arbitrary — it’s mandatory for patients’ good health.

With continued expansion of the recalls for various angiotensin II receptor blockers (ARBs), many patients, pharmacists and prescribers are left seeking guidance. Various products containing irbesartan, losartan and valsartan — all ARBs — have been affected by the recall. These include all strengths of these individual products, as well as some products that combine one of the ARBs with amlodipine, hydrochlorothiazide or both.

A wealth of information regarding the recall can be found at the FDA website. The site includes links to charts of products under voluntary recall by a number of manufacturers, as well as an FDA table of interim acceptable intake levels.

Obviously, if you or your patient is taking one of these affected products, we need to address how to manage blood pressure, heart failure, kidney function, or other cardiac concerns in the absence of the ARB.

How did this happen and what does it mean?

An impurity in the active ingredient (the ARB) during the manufacturing process was found to be a probable human carcinogen, or a chemical that increases the chance of developing cancer. These impurities are nitrosamines and are generally accepted to be carcinogens in humans.

Nitrosamines can be found in tobacco products and tobacco smoke as well as many foods, including fish, beer, fried foods, and meats. Limits of these nitrosamines are set by the U.S. Environmental Protection Agency(EPA) and the FDA. The guidelines are set to limit — over the course of a person’s life — that nitrosamines would cause less than one additional case of cancer for every 100,000 people exposed.

With the amounts of nitrosamines in the recalled ARBs, if a patient took the maximum daily ARB dose for four years, there would be an additional case of cancer for every 8,000 people exposed. That’s a significantly increased risk with the recalled products — 0.0125% (1 in 8,000) versus the target of less than 0.001% (1 in 100,000). It’s true that the current risk of cancer in the U.S. is already 1 out of every 3 people, so the added risk is miniscule in comparison. However, knowingly producing a product that is known to increase the risk of cancer is generally frowned upon…and rightly so.

What do we do now?

The good news is that not all lots of all drugs were affected. If you were taking or prescribing one of the recalled lots, then we can change to another manufacturer’s version or one that doesn’t have the carcinogen issue. The FDA’s webpage has updated lists of both recalled ARBs as well as options available that aren’t affected by the recall.

If the ARB is not in stock at the pharmacy, there are options for ARB conversion, with several references available to convert from one ARB to another. Global RPh has a free source-comparison page for easy conversion. TRC’s Pharmacist Letter also has good conversion charts, although they’re only available if you’re a site subscriber.

If you’re using one of the recalled combo products, you’ll likely need to switch to single-ingredient products and possibly switch the ARB. There’s also the option of switching to an ACE-inhibitor, which in general has much more robust data in treating both hypertension and heart failure. The caveat here is avoiding the common ACE-inhibitor cough side effect that may have been the reason for initially selecting the ARB.

As manufacturers work to replenish their supply to pre-recall levels, we’re here to help providers and patients select appropriate alternatives to achieve therapeutic goals. And if we can avoid increasing the cancer risk, that’s obviously a good idea as well.

Kristen Engelen, PharmD
Kristen Engelen, PharmD, is the chief pharmacy officer of RxLive and a certified consultant pharmacist; she has over a decade of experience in retail pharmacy settings. Kristen became an RxLive co-founder because of her passion for geriatric pharmacy, with a focus on the intersection of pharmacy and aging.