ARB Recalls

I was recently asked to speak on the radio about the recent recalls of blood pressure medications. This is the link to the podcast, but we were limited on time, so I thought I would write more about it here. If you need a refresher on hypertension, check out my post here.

What medications have been recalled?

Some lots of the medications valsartan, losartan, and irbesartan have been recalled because of impurities found in them. You will notice that they all end in -sartan. This is because they all belong to the same class of medications, called angiotensin receptor blockers, or ARBs. They all block the effects of a hormone called angiotensin II, which acts to cause blood vessels to constrict, or squeeze.  This results in higher blood pressures, just like squeezing a balloon will increase the pressure inside of the balloon.  When the action of angiotensin II is blocked, blood vessels loosen, and blood pressure goes down.

Tell me more about ARBs

ARBs act on the same pathway as another class of medicine called ACE inhibitors. The names of ACE inhibitors end in -pril, such as lisinopril and enalapril. ACE inhibitors can occasionally cause a dry cough or more serious side effect called angioedema (swelling of the mouth, tongue, and throat). When this occurs, patients are often switched to ARBs because they are associated with decreased rates of these side effects.

In the past, when ACE inhibitors were generic and ARBs were not, the standard practice was to only use an ARB if someone had a side effect to an ACE inhibitor.  Now that ARBs are generic also, many physicians (including myself) will use ARBs initially because of their better side effect profile.

ARBs and ACE inhibitors are very commonly used to treat hypertension. They are considered first-line treatment options for hypertension, along with two other classes of medications (calcium channel blockers and thiazide diuretics).  They are also used for certain patient with heart failure, and can help protect against progressive kidney damage in patients with diabetes.

ARBs have very few side effects, but they can alter kidney function and increase potassium levels, so physicians often check blood work after starting or adjusting these medications.

Why have there been recalls?

In the summer of 2018, trace amounts of impurities were found in some lots of valsartan produced by some manufacturers. These impurities are chemicals known as NDMA and NDEA, which are known to be carcinogens at high enough of doses.

Note that some ARBs in combination pills with other medications such as amlodipine and hydrochlorothiazide have also been recalled, but single-medication amlodipine pills and hydrochlorothiazide pills have NOT been affected. Amlodipine and hydrochlorothiazide are extremely common medications and I have a received a number of calls from patients with this concern, but once again, amlodipine and hydrochlorothiazide on their own are not affected.

What is the risk?

The FDA estimates the cancer risk due to these impurities to be negligible. The estimated increase in risk in patients who consumed the highest amount of the impurities would be 1 case of cancer for every 8000 people. To put this in context, this is one-sixth the risk of cancer attributed to the radiation from having a CT scan done at age 45.  Additionally, 1 in 3 people in the United States gets cancer in their lifetime, which dwarfs the additional risk posed by these impurities.

“What should I do?”

If you are on valsartan, losartan, or irbesartan, check with your pharmacist and see if you are affected by the recall. If you are, ask your pharmacist what you can do. Often, you can be changed to an unaffected lot of the same medication. If that is not possible due to shortages, there are 8 different ARBs available, 7 of which are available generically, so your physician should be able to change you to an equivalent dose of an unaffected medication.

In general, the ARBs are interchangeable with similar side effect profiles and effectiveness.  I have a very small number of patients that have had side effects with one ARB, but do well on another.  This is pretty rare.

There is one slight exception to the interchangeability of the ARBs that even most physicians are unaware of. Losartan decreases the level of uric acid slightly, while the other ARBs cause a slight increase in uric acid levels. Uric acid, in elevated levels, can cause gout.  For this reason, I will often choose losartan as a blood pressure medication in patients with gout.  Switching from losartan to another ARB could theoretically increase gout flares in a patient that has gout.  Speak to your physician if this is a concern.

If you are concerned about cancer risk, remember that the additional risk is negligible. You should undergo age-appropriate cancer screening at your physician’s recommendation, just like everybody else.

If you take medications, don’t be scared or upset.  There are hundreds of millions of prescriptions filled in this country every year, and recalls are rare.  However, you can let this serve as motivation. Hypertension is largely a lifestyle-induced disease, and many patients can reduce their need for medications through increased exercise, improved diet, and quitting smoking. While medications can help, they are a treatment, not a cure. It may be easier to take pills, but exercise and healthy eating have benefits that go far beyond blood pressure control. Healthy lifestyles are associated with other medical benefits such as decreased cancer risk, but also improved mood, better sleep, decreased pain, and increased energy.