Over the past several months a few generic manufacturers have issued recalls on various blood pressure medications. Valsartan has been affected the most by these recalls but other medications in the same category have been affected as well. Do you take valsartan? If so, is your medication affected by the valsartan recall? We take a look at what caused the recall, who is affected, and what to do if your medication was on the valsartan recall or one of the subsequent recalls that followed.
Why Did the Valsartan Recall Happen?
This is a good place to start our analysis. The first recall of valsartan products happened late in 2018 due to impurities found in some valsartan tablets. Two byproducts have been found in various formulations of blood pressure medications from the initial recall until now. The two byproducts known by the abbreviations NDMA or NDEA are on the FDA’s list of suspected human carcinogens, meaning they may be cancer-causing. Two manufacturing facilities, one in China and one in India, who use similar manufacturing processes have been identified as the source of the byproducts. The recalls state that the recalled products MAY contain trace amounts of either NDMA or NDEA. The byproducts are not related to valsartan, rather were likely created due to an unintended chemical reaction that occurred during the manufacturing process.
It is important to note that the byproducts (or impurities) were discovered during a quality control assessment and so far have not been linked to any cases of cancer and there are no reports of any harm that has been done to a patient. Also important is the fact that valsartan and other affected medications are not the cause of the problem. They are safe to use. The manufacturing process is what has been deemed unsafe, which led to this recall.
What Products Have Been Affected?
Valsartan has been the focus of many of the recalls but there are several other medications that have also been recalled for a similar reason. Valsartan belongs to a class of blood pressure lowering medications called angiotensin receptor blockers or ARBs for short. This class includes several different medications including irbesartan, losartan, olmesartan, and telmisartan. As of February 2019 I have seen specific lots of all of these medications recalled (except telmisartan) for the same reason. Valsartan has been affected the most to this point. Various manufacturers have issued valsartan recalls including Mylan, Solco, Teva, Aurobindo, Torrent, and Camber.
For a complete list of recalls you can search for your medication on the FDA website.
What Do I Do If My Medication Was Affected?
First off, DO NOT STOP TAKING YOUR MEDICATION until you have a suitable replacement. If you stop your medication out of fear of taking a recalled product you may cause your blood pressure to become uncontrolled. This could cause you much more harm than taking a medication that might have an impurity in it that might be carcinogenic. Your first step should be to visit the FDA recall website which is linked above. If your drug and manufacturer is on the list then call your pharmacy to see if your product is possibly affected. When recalls are made the manufacturer lists all lots of the medication that could be affected. Your pharmacy may not know which exact lot your medication came from. They will have pulled all affected lots off of their shelves when the recall happened but it might be hard to determine if that was done before or after your medication was dispensed. Your pharmacy will have a policy in place on how to handle the medication in question. At my store we always replace the tablets with a non-recalled product if there is any question.
Make sure your pharmacy takes care of this request to your satisfaction. If not, you may need a new pharmacy. Find out how to shop for one here. Blood pressure medications are not expensive, so even if you have to pay cash for a new prescription at a different pharmacy it may be worth it, if only from a peace of mind perspective.
What Are the Factories Doing to Correct This?
By looking at the number of manufacturers who have issued recalls, it may be fair to assume that the two facilities that have been identified as the source of the problem may be supplying a large percentage of valsartan that is used in all pharmacies. In other words, they make product for multiple companies, who then rebrand and market that medication under their own brand. Also in question is how much oversight these facilities receive. Do FDA inspectors really get to India and China enough to make sure these facilities are doing things the right way? I have many patients ask me to provide them only with medication that was made in the United States. Unfortunately, US-based manufacturers are hard to find as most companies rely on India and China to perform this work.
The good news is that now these manufacturing processes have been identified, they will be able to be fixed. How long this has been going on, and how many people have taken affected product may never be known. Halts in production may also lead to product shortages. As facilities re-tool their processes they are not able to keep up with demand. Other facilities that also make valsartan were not prepared for the exit of a competitor and need time to adjust. Resulting temporary shortages have been seen and will continue to be a problem going forward. If you are taking any ARB medication please stay on top of this.
What Actions Should I Take?
Call your refills in early. I recommend calling them in a week ahead of time. That way, if the pharmacy is having a supply issue, they will have more time to work it out. Wholesaler out-of-stock issues are usually intermittent and are resolved in a short amount of time. However, if you wait until you are out of medication to ask for a refill you could be putting yourself in a bad position. Switching from valsartan to another type of blood pressure medication might be a good idea. If valsartan recalls continue, you may continue to receive medication that needs to be returned to the pharmacy. Switching to olmesartan or telmisartan my help you avoid future recalls. If you do switch medications, you will need to be sure to monitor your blood pressure very closely during the transition. You can read this article to learn more about how and when to check your blood pressure.
It is also wise to replace your in-home blood pressure monitor about every 2 years or so if you use it a lot. If you need to purchase a new blood pressure monitor you can use this link to find a good list of available products.
Conclusion
Here are the takeaways you need to remember from this article. Several companies are involved in the valsartan recall. Other blood pressure medications are also affected. Be sure to check the FDA website for specifics. Talk to your pharmacist if you suspect your medication might be affected. Do not stop taking your medication. Uncontrolled blood pressure will put you at more risk than taking a product that might be affected by this recall. I will keep you updated if there are any major changes. I expect that this issue will soon be resolved, as will the product shortages that may result from it. Feel free to leave a comment or contact me directly should you have any questions.
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HP
Thanks HP for the update. I do take Ibersartan & was able to ascertain that my batch was not involved but no additional information was forthcoming so it is reassuring to understand what is being done at the manufacturing level. Please keep us advised of other notices on recalls.