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, , opens new window
A chart highlighting generic ACE Inhibitor medication tiers
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
A chart highlighting initial dosing and maintenance ranges ACE Inhibitors
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.
Information for your patients
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Patients should visit the FDA website or their pharmacy to see the latest ARB recall updates.
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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.
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If the information is not on the bottle, contact the pharmacy that dispensed the medicine.
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If the NDC is included in the recall, contact the dispensing pharmacy to identify, by lot, if their medicine is impacted.
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If patient’s medicine is recalled, they should:
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Continue to take the recalled medicine until they have a replacement.
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Contact their healthcare professionals to discuss treatment options.
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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.
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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.
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Online: , opens new window
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Regular mail or fax: , opens new window or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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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:
- “ACE Inhibitor Antihypertensive Dose Comparison,” Therapeutic Research Center, last accessed March 7, 2019, , opens new window.