Impact of ongoing angiotensin II receptor blocker drug recalls

A physician holds a vial of pills while taking notes at a computer.

With the large scale of angiotensin II receptor blocker (ARB) drug recalls, Humana anticipates the recalls to continue. To reduce impact to your patients, please consider switching them from ARB medications to other clinically appropriate drug therapies, such as angiotensin-converting enzyme inhibitors (ACE-I)1.

Due to the ongoing investigation, monitor the U.S. Food and Drug Administration (FDA) website for the most up-to-date ARB recall information., opens new window

ACE inhibitor recommendations table 1

Medication – generic name Prescription drug plan tier Medicare Advantage prescription drug plan tier Commercial tier

lisinopril

1

1

1

benazepril

1

1

1

enalapril

2

1

1/2

quinapril

1/2

1

1/2

ramipril

1/2

1

1/2

lisinopril/ hydrochlorothiazide (HCTZ)

1

1

1

benazepril/HCTZ

2

2

1/2

enalapril/HCTZ

1/2

1/2

1/2

quinapril/HCTZ

2

2

1/2

benazepril/amlodipine

2

2

1/2


ACE inhibitor recommendations table 2

 

Medication – generic name

Initial dosing for hypertension

Maintenance range for hypertension

lisinopril

10 mg daily

10–40 mg/day

lisinopril/HCTZ

5 mg daily

10–40 mg/day

benazepril

10 mg daily

10–40 mg/day

benazepril/HCTZ

5 mg daily

10–40 mg/day

enalapril

5 mg daily

5–40 mg/day

enalapril/HCTZ

2.5 mg daily

5–40 mg/day

quinapril

10–20 mg daily

20–80 mg/day

quinapril/HCTZ

5 mg daily

20–80 mg/day

ramipril

2.5 mg daily

2.5–20 mg/day

ramipril/HCTZ

1.25 mg daily

2.5–20 mg/day


For formulary information on alternative medications, visit Humana’s Provider Drug List search. , opens new window

Information for your patients

  • Patients should visit the FDA website or their pharmacy to see the latest ARB recall updates.

  • To determine if a specific medicine is part of the recall, look at the drug name and National Drug Code (NDC) on the label of their prescription bottles.

    • If the information is not on the bottle, contact the pharmacy that dispensed the medicine.

    • If the NDC is included in the recall, contact the dispensing pharmacy to identify, by lot, if their medicine is impacted.

  • If patient’s medicine is recalled, they should:

    • Continue to take the recalled medicine until they have a replacement.

    • Contact their healthcare professionals to discuss treatment options.

  • The Center for Drug Evaluation and Research (CDER) has skilled pharmacists and nurses available to the public for questions via phone at a toll-free number 1-855-543-3784 or email at druginfo@fda.hss.gov.

  • Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Background

The FDA initially announced a recall on select valsartan-containing medications on July 13, 2018. It has continued to expand recalls to additional valsartan-, irbesartan- and losartan-containing medications. These recalls occurred due to trace amounts of nitrosamine impurities, including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), identified in the active pharmaceutical ingredients (API) manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. in China. These impurities are classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC). NDMA and NDEA are found in trace amounts in water and some foods; however, the amounts identified in the drug products are at unacceptable levels.

Sources:

  1. “ACE Inhibitor Antihypertensive Dose Comparison,” Therapeutic Research Center, last accessed March 7, 2019, https://pharmacist.therapeuticresearch.com/Content/Segments/PRL/2009/Aug/ACE-Inhibitor-Antihypertensive-Dose-Comparison-1719 , opens new window.