Friday, December 14, 2018

Blood Pressure Medicine Recalls

I have been meaning to write a quick summary of all the recent blood pressure medicine recalls. Especially with all the worried calls we've been getting in our office, I want to offer some reassurance and guidance.

Since late summer, there has been a lot of media about certain blood pressure medicines being recalled because they contain an impurity N-nitrosodimethylamine (NDMA) . 

The first FDA recall for this issue was around July 2018... but since then the list has been expanding with the most recent recall made on December 4, 2018. Here is a summary of the blood pressure medicines that are affected so far. This list is taken from FDA website:

12/04/2018Mylan  Valsartan-containing products  Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical IngredientMylan Pharmaceuticals
11/27/2018Teva Pharmaceuticals Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets  Impurity N-nitroso-diethylamine (NDEA) in APITeva Pharmaceuticals
11/20/2018Mylan  Amlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets  Contain trace amounts of an impurity, N-nitrosodiethylamine (NDEA)Mylan Pharmaceuticals
11/08/2018Losartan  Losartan Potassium Hydrochlorothiazide  Product contains NDEA impuritySandoz Inc
10/30/2018WP Westminster, more  Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms  due to the presence of an impurity, N-nitrosodiethylamine (NDEA)ScieGen Pharmaceuticals, Inc
10/26/2018Aurobindo Pharma Limited  Irbesartan Drug  Due to the presence of an impurity, N-nitrosodiethylamine (NDEA)Aurobindo Pharma Limited
08/23/2018Torrent Pharmaceuticals Limited  Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets  Impurity detected in the API is N-nitrosodimethylamine (NDMA)Torrent Pharmaceuticals Limited
08/17/2018Torrent  Valsartan/Amlodipine/HCTZ Tablets  Impurity detected in the API is N-nitrosodimethylamine (NDMA)Torrent Pharmaceuticals
08/08/2018Camber Pharmaceuticals, Inc.  Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg  Detection of trace amounts of N-Nitrosodimethylamine (NDMA)Camber Pharmaceuticals, Inc.
07/17/2018Actavis  Valsartan and Valsartan Hydrochlorothiazide Tablets  Impurity detected in the API is Nnitrosodimethylamine (NDMA)Teva Pharmaceuticals USA
07/17/2018Prinston Pharmaceutical Inc. dba Solco Healthcare LLC  Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg  Detection of a Trace Amount of Unexpected Impurity, N- nitrosodimethylamine (NDMA)Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
07/13/2018Major Pharmaceuticals Valsartan tablets, 80mg USP and 160 mg USP  may contain the probable carcinogen Nnitrosodimethylamine (NDMA)Major Pharmaceuticals
So what to do?

If your medication is on the recall list, you should have been contacted by your pharmacy. If you are not sure you can always call your pharmacy to find out.

The label on your medication bottle should tell you which company manufactured that medicine.

If your medicine is affected, speak with your physician for an alternative. This requires careful consultation because the type and dosage of medicine you can be switched to depends on your medical history and current health.

Also to note... the medicines on this list are all generics made by different manufacturing companies. So far there has been no recall on the actual brand name product.

Valsartan = generic for Diovan  (made by Novartis)
Losartan = generic for Cozaar (made by Merck)
Irbesartan = generic for Avapro (made by Sanofi)
Amlodipine = generic for Norvasc (made by Pfizer)

Brand name medicines cost a lot more than generics. However, with commercial insurance sometimes the company will offer coupons where the co-pay is lowered. Unfortunately, the coupons do not work with medicare patients. Again, consult with your physician about what is best for you.

Hope this helps!