Wisdom Wednesday: Continuing ARB Recalls Shake Up Hypertension, HF Care

Concerns over ongoing recalls of angiotensin II receptor blockers (ARBs) are forcing physicians and patients to choose between optimal treatments and rattling confidence in the safety of the generic drug supply itself.

"I see hypertension on a regular basis and on any given clinic day, four to five patients have either stopped their medicines or have considered stopping their medicines and a separate detailed conversation has to be put in place to try to convince them to continue," Keith Ferdinand, MD, Tulane University Heart and Vascular Institute, New Orleans, told theheart.org | Medscape Cardiology.

ARBs are recommended for the treatment of hypertension, heart failure, and chronic kidney disease, with more than 61 million prescriptions written for valsartan, losartan, and irbesartin in the United States in 2016, according to the federal ClinCalc DrugStats database.

Ongoing US Food and Drug Administration (FDA) recalls — all in generic ARB-containing products — began last July when the probable carcinogen N-nitrosodimethylamine (NDMA) was detected in the valsartan active pharmaceutical ingredient (API) supplied by Zhejiang Huahai Pharmaceuticals (ZHP), Linhai, China.

Within months, the rolling recalls had extended to irbesartan- and losartan-containing products. A second probable carcinogen, N-nitrosodiethylamine (NDEA), was identified last fall and a third, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), only last month.



George Bakris, MD, director of the hypertension unit, University of Chicago, said his patients are aware of the cancer risk but haven't stopped taking medications. Initially he advised them to remain on valsartan if insurance wouldn't pay for an alternative ARB and the pharmacy could verify the drug was not made in China. Nevertheless, more than 85% switched.

My Take:
Angiotensin II receptor blockers (ARBs) have replaced ACE inhibitors, beta blockers and calcium channel blockers as preferred drugs in the treatment of hypertension, heart failure, and chronic kidney disease. Please type “hypertension” into the search box in the upper left hand corner of my blog site to see my previous posts on this subject.

Medication for hypertension is typically how most patients start down the path to polypharmacy. I believe that congestive heart failure is often the result of taking these medications long term.

The tone of this article suggests patients should just take the drugs and not worry about the risk of cancer. What an inconvenience for the physician to have a separate detailed conversation to try to convince them to continue. Apparently, these conversations are not very effective as another doctor reports 85% of patients subsequently switched.

Bottom Line:
Lifestyle changes can prevent or reverse hypertension, even after the introduction of medication. Weight loss, regular exercise, even naps have been shown to reduce hypertension as effectively as these drugs.

Source: March 28, 2019 NIH