On January 3, 2019, the Food and Drug Administration (FDA) posted an updated notice to consumers explaining that Torrent Pharmaceuticals was expanding its recall to eight (8) additional lots of its high blood pressure medication Losartan. This recall is a continuation of what started over the past summer on July 27, 2018. The FDA initially warned that certain batches of the high blood pressure drug Valsartan had been contaminated with the chemical N-nitrosodimethylamine (NDMA). To date, there have been numerous recalls issued to multiple manufacturers of these specific high blood pressure drugs.

The FDA’s recall this past July came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.

Based on additional findings by the FDA, the NDMA contained in these recalled products was manufactured by a company in China called Zhejiang Huahai Pharmaceuticals.

NDMA is known to cause cancer as well as liver damage. The FDA believes “the NDMA is related to changes in the way the active substance was manufactured” and that “some levels of impurity may have been in the valsartan containing products for as long as four years.”  

The recall itself is frightening. The folks taking these medications are already dealing with cardiovascular issues and high-blood pressure. Plus, how many people in this country understood at the time they were given their prescriptions that the drugs they were ingesting were being manufactured or had traveled all over the world from places like Israel, India, or even China.

Let’s say, for example, you live in a small rural community in the Midwest. Like so many other people in this country, you suffer from high-blood pressure. You’ve tried changing your diet, you’ve been exercising regularly, and you’ve tried anti-anxiety therapies as well. After exhausting numerous options to bring down your blood pressure, your doctor finally tells you it’s time to get on some medication. So, that’s what you do. Over the next year or two, you get your blood pressure under control and feel like your life is back to normal. Then the FDA issues the recall this past July and you find out that the medication you’ve been taking to manage your blood pressure was contaminated with a potentially cancer-causing ingredient. Also, it came from China.  

This Valsartan and Losartan recall speak to a bigger issue we all currently face when we take a prescription drug or have a medical device implant. Where exactly are all of these prescription drugs or medical devices being manufactured or sent before we ingest them or have them implanted in our bodies?

A pharmaceutical consulting group called Evaluate recently issued a report this past June predicting where global pharmaceutical sales would be by 2024. After conducting exhaustive research with the world’s leading 7,000 pharmaceutical and biotech companies, the report concluded that, globally, “total prescription sales are expected to be $1.2trn in 2024.”

Similarly, this past April, a research consulting group called Lucintel conducted a similar study to the global medical device market. The results from that study predicted enormous amounts of future sales across the world: “the global medical device market is expected to reach an estimated $409.5 billion by 2023.”

Yes, it may be our local doctor in our local community who is giving the prescription. Yes, it may be a local surgeon who performed our medical device implant surgery. We may know the doctor, but what do we know about the pill(s) they prescribe us or the medical device(s) they implant us with? Even scarier, given the fact that so many prescriptions were issued for these contaminated high-blood pressure medications, how much information do your healthcare providers have as well?  

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