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    Michael L. Aaronson, MD
    Kidney Doctor and High Blood Pressure Specialist
    7401 O Street Lincoln, NE 68510
    Phone: 402-484-5600

    Saturday, February 16, 2019

    Blood Pressure Medication Recall! What is the Next Step?

    Losartan and other antihypertensive medications have recently been recalled. As a specialist in the treatment of high blood pressure and diabetic kidney disease, I am one of the many providers receiving phone calls from patients who are taking this therapy. People have concerns. They have questions regarding the next steps. Should they get off the medication (were they affected by the recall)? What is the best way to proceed?

    Figure: The 10 most written prescription drugs in the United States (2016 Data):



    Four of the 10 most written medications: lisinopril, amlodipine, metoprolol, and losartan are all blood pressure medications. Note that losartan made the top 10 and was one of the medications recently recalled because of impurities found in some of the pills. Adding the 5 million prescriptions written yearly for the losartan hctz diuretic water pill combination, over 54 million people were at possible risk of being affected by the losartan recall. This does not include other medications in the angiotensin receptor blocker class that were included in the recall.

    The data is clear: the blood pressure medication recall is affecting many people's lives. And that's why a systematic approach to handling medication recalls is important. I, Dr. Michael Aaronson, in order to help you better your health in this setting will offer in this blog a systematic approach to take if you find out a medication you are on is recalled.

    Backgrounder: Impurities were found in some of the lots of the fourth most common anti-hypertensive blood pressure medication prescribed in the United States called losartan potassium. Certain lots were recalled, not all of them. The recall was announced on December 20, 2018 with an update expanding the recall issued January 22, 2019.

    The reason for the recall is the amount of N-nitrosodiethylamine (NDEA) levels present in the formulation. The NDEA is considered an impurity and can be harmful to your health.

    Sidebar: Losartan belongs to a class of medications called angiotensin receptor blockers. They are blood pressure medications used to reduce blood pressure, treat diabetic nephropathy (also called diabetic chronic kidney disease), and protein in the urine. These blockbuster medications are also prescribed by physicians for other reasons such as heart failure. Given the many indications for use, you may have been given the drug from either your primary provider, your endocrinologist, your nephrologist, or your cardiologist.

    To make matters even more complicated, multiple angiotensin receptor blockers (ARBs) such as valsartan, irbesartan, and losartan have been recalled by companies for the possible presence of NDEA. The official recommendation has been to stay on the therapy given the benefit to risk of taking the medicine versus stopping it until you can get an unaffected batch from your pharmacy, or your provider can offer an alternative.

    Let's define the scope of the problem in terms of the possible number of people affected (and this is likely an underestimation): Based on 2016 total prescriptions written in the United States there were the following number of ARB prescriptions affected by the recall. They are affected because even though their medicine may be pure, it may not be, and they need to check:

    • Name of Drug, Number of Prescriptions Written
    • Losartan Potassium 49,281,054 
    • Hydrochlorothiazide; Losartan Potassium 9,772,428 
    • Valsartan 8,406,000 
    • Hydrochlorothiazide; Valsartan 5,000,778 
    • Irbesartan 3,615,078 
    Please note: there are likely more patients affected by the blood pressure medication recall because I just searched the database of the top 300 drugs to get some basic information. I didn't search for all the possible combinations. Moreover, this information is dated and obtained from 2016 data. Newer data can be obtained from the Medical Expenditure Panel Survey if you are interested.

    So you are taking one of these therapies. You are concerned you may be affected by the recall. Your doctor gave you a 90 day supply with 3 refills. Your next appointment with your kidney doctor isn't for 8 months. What do you do next? What are the next steps?

    You can approach a blood pressure medicine recall in a few ways. Here are my suggested steps:

    1. Get your losartan prescription bottle (or recall medication bottle), and call your pharmacy to see if the medication you are taking is affected by the recall. They can help you. The bottle will have the information required to determine if action is needed.
      1. Note that losartan is a generic medication. Several companies make it. Some of the 54 million patients are taking pure losartan. Others are not. If you aren't taking impure medication, then there is no need to worry.
      2. Also note that if this were a trade medication, made by one manufacturer, the process would be different. It is possible that all the medication would need to be recalled, replaced, or switched.
    2.  Let's say you want to change to a different medication in the ARB class. You can call your doctor and ask for a switch. Your kidney doctor can pick one for you.
      1. This is a "heads up" for the providers out there. Consider selecting an option 1, 2, and 3. Many insurance companies may not approve your first or second choice. To avoid unnecessary delays changing therapy, consider this strategy to get your patients the medication they need as quickly as possible
    3. Consider scheduling a follow up with your hypertension specialist sooner to make sure the new medication is working for you. Not all angiotensin receptor blockers are the same. There are conversion tables but in my experience, and I'm an expert, some ARBs are more powerful than others, and some are weaker than others. So you may want to be evaluated sooner to see how the new medication works in your body, including the effect on your kidney function. 
      1. Moreover, blood pressure guidelines have changed, and many organizations recommend blood pressure goals that are less than 130/80 instead of 140/90. Your blood pressure goals may be different. So this unfortunate event may be an opportunity for a "tune up" if you haven't seen your doctor in a while.
      2. In this context, you may be placed on a different ARB for its mechanism of action and another blood pressure pill to get you to goal. That will require a follow up visit with your health care provider.

    There are many ways to approach a medication recall, and different systems of care do it differently. I would consider Dr. Michael Aaronson's above method. This strategy prevents you, the patient, from getting "missed" and empowers you to take control of your healthcare, avoiding delays.