Impact of ongoing angiotensin II receptor blocker drug recalls

A couple researching a prescription online

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.

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

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. 

                    Online:        Complete and submit the report        



                Regular mail or fax:        Download form        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.





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.

“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.



Drug recall notice for quinapril products

Drug recall notice for Nature-Throid and WP Thyroid tablets

Drug recall notice for Belviq, Belviq XR (lorcaserin)

Drug recall notice for NP Thyroid tablets

Drug recall notice for Taro Pharmaceuticals phenytoin oral suspension

Formulary changes for generic Ventolin HFA

Medicamento: nombre genérico	Nivel del plan de medicamentos recetados	Nivel del plan de medicamentos recetados de Medicare Advantage	Nivel comercial
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/hidroclorotiazida (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/amlodipino	2	2	1/2

Medicamento: nombre genérico	Dosis inicial para hipertensión	Rango de mantenimiento para hipertensión
lisinopril	10 mg por día	10–40 mg/día
lisinopril/HCTZ	5 mg por día	10–40 mg/día
benazepril	10 mg por día	10–40 mg/día
benazepril/HCTZ	5 mg por día	10–40 mg/día
enalapril	5 mg por día	5–40 mg/día
enalapril/HCTZ	2.5 mg diarios	5–40 mg/día
quinapril	10–20 mg diarios	20–80 mg/día
quinapril/HCTZ	5 mg por día	20–80 mg/día
ramipril	2.5 mg diarios	2.5–20 mg/día
ramipril/HCTZ	1.25 mg diarios	2.5–20 mg/día

Tabla de recomendaciones 1 sobre el inhibidor de ACE

Tabla de recomendaciones 2 sobre el inhibidor de ACE

Fuentes:

Noticias sobre farmacia

Tabla de recomendaciones 1 sobre el inhibidor de ACE​​

Tabla de recomendaciones 2 sobre el inhibidor de ACE​​

Fuentes:​​

Noticias sobre farmacia​​

Tabla de recomendaciones 1 sobre el inhibidor de ACE

Tabla de recomendaciones 2 sobre el inhibidor de ACE

Fuentes:

Noticias sobre farmacia