If you have high blood pressure, first of all, congrats on knowing you have it. If you’re taking a medication to help control it, you have to read this. In case you missed it, there have been a series of press releases and news stories on recalls related to several medications that belong to a family called angiotensin receptor blockers (ARB), which specifically include valsartan, irbesartan, and losartan. The recalls are secondary to the FDA discovering that potentially cancer-causing contaminants were found in various forms of these pills. It’s crucial to know that just because you take a medication that contains one of these, it doesn’t mean that you’re going to get cancer. There is, however, a way to figure out if you were affected by this recall. Here are the details of the recalls that have happened so far.
The FDA first announced a recall in July 2018 after finding that an inactive ingredient called NDMA (N-nitrosodimethylamine), which can cause cancer, was found in a generic form of the blood pressure medicine valsartan. Firstly, the potentially harmful contaminant was linked to 2 suppliers of the active ingredient used to make the pills: Zhejiang Huahai Pharmaceutical Co. Ltd in China and Camber Pharmaceuticals in India. These manufacturing companies were selling the affected medication under the following company names: Major Pharmaceuticals, Solco Healthcare, Prinston Pharmaceuticals, Actavis LLC, Teva Pharmaceuticals, Torrent Pharmaceuticals Limited, A-S Medication Solutions LLC, AvKARE, and RemedyRepack. They estimate that the longest this had gone on prior to being discovered would have been about 4 years.
Additionally, based on the levels of NDMA that are considered potentially harmful and the levels they found in the contaminated pills, there could be approximately be 1 case of cancer attributable to this contaminant for every 8000 people taking the pills. This recall originally included valsartan and a combination pill containing valsartan and hydrochlorothiazide. It has since expanded to include some forms of combination pills containing valsartan along with hydrochlorothiazide and amlodipine.
A chemical related to NDMA called N-Nitrosodiethylamine (NDEA) has also been found in valsartan from a different company called Mylan Pharmaceuticals, which has now also been recalled. NDEA has been found in the other ARB’s, irbesartan and losartan. Its discovery in irbesartan prompted a recall in October 2018 of the drug made from one particular manufacturer called Aurobindo in India and sold by ScieGen (also labelled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc). In November 2018, they found unacceptable levels of NDEA in losartan, which also had its active ingredient manufactured at Zhejian Huahai Pharmaceutical Co. Ltd and recalled a combination medication made by Sandoz of losartan and hydrochlorothiazide.
What It Means For You
As part of this large investigation that leaves many questioning the standards of the generic drug industry, the FDA published the amount of NDMA found in various samples of the pills they tested. According to food chemistry research, NDMA-like compounds do occur in common foods at low levels. They are found in highest levels in cured and smoked meats and fish. However, to put things in perspective, the levels found in the affected pills were at levels 10-100 times as high per pill as there would be in approximately 1 pound of each of these meats.
If you’re in the boat of people who are questioning the generic drug industry, you have the right to do so. In general, generic drugs just need to prove that the active ingredient of the brand name medication reaches the same therapeutic level in your body within plus or minus roughly 20%! For certain medications that have serious side effects, that can be a huge difference! It is not necessarily a requirement to demonstrate safety or detail the process of including all the inactive ingredients in the generic form of the medication. Since generic medications are not usually the ones tested in large clinical trials that lead to the approval of new medications, adverse effects and other findings like those detailed above are often only found after they’re approved.
Still with me? Don’t freak out. If you’re taking one of these medications mentioned above and aren’t sure if it was included in the recall, you can ask your pharmacist to help you figure that out and speak with your doctor to see if any changes need to be made. Heart disease is more common and kills more people than all cancers combined. Treating blood pressure, among other risk factors for heart disease, is crucial to helping you live a long healthy, life.
If you have questions about heart disease, your medications, or the recall, contact us here.