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Skeptical Cardiologist: Where Are My Generic Meds Made?

— Valsartan recall prompts a look by Anthony Pearson, MD

Ƶ MedicalToday
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FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and .

Since then I have switched many patients from the bad valsartan to losartan or valsartan from presumably-safe manufacturers.

It didn't really occur to me that this could be just the tip of the iceberg until I received a reader comment, copied below. As I thought about it, I realized that I have no idea where the generic ramipril I am taking is manufactured. It very well could be in China or India.

This from The Epoch Times confirms that Americans are becoming more and more reliant on medications manufactured in China and that many researchers feel this poses a significant security threat:

"The Food and Drug Administration (FDA) is inspecting only a small number of the Chinese companies that manufacture U.S. drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the United States from China, either as finished products or as ingredients, are often falling far below U.S. safety standards. And some of these drugs are not being inspected at all."

The book by Rosemary Gibson and Janardan Prasad Singh details the problem.

It is very hard to find out how many U.S. drugs come from China, because drug companies don't make their sources apparent. In addition, even if the drugs themselves aren't manufactured in China, Gibson and Singh write, "China is the largest global supplier of the active ingredients and chemical building blocks needed to make many prescription drugs, over the counter products and vitamins."

Below are the comments of my reader:

"This is horrible. We have a problem in the U.S. It is the infiltration of Chinese generics. I had no idea that this generic was being supplied by a Chinese maker. In fact, the bottles I got said "SOLCO" which is based in New Jersey. Now I'm painfully aware that SOLCO Healthcare US which is based in New Jersey, is owned by Zhejiang Huahai Paarmaceutical based in China's Zhejiang Province. So this is the Chinese company's subsidiary distributing this drug in the U.S. China has a long history of selling tainted products in the U.S. Chinese drywall, lead-based paint on toys, tainted pet food, etc. Now it is important to understand that 85% of prescriptions filled in the U.S. are generic. And insurance companies will not pay for brand when generic is available. My valsartan was about $30 for 90 days. Diovan is $750. I get it. But when these companies cut corners and people are endangered, something is wrong. I will never ever take another generic drug without first finding out where the product comes from. I know this is not perfect, but it is something. I think the U.S. lawmakers need to do something to make this information more transparent. It baffles me as to how this drug could have been tainted with a highly toxic chemical for so many years (they now say 4 years). This chemical is known to cause liver damage and cancer. Apparently the manufacturer changed the way it made the active ingredient which created this poison by-product. And now who do we hold accountable? How do we get to the bottom of what went wrong, and how to prevent this going forward. We have no way to compel anything in China. All that said, thanks for your information here it is helpful. I worry that the losartan is made by the same company – I will surely investigate."

China is also flooding the American market with useless over-the-counter (OTC) medications. I realized this when I looked closely at the It has no active ingredient that could be realistically thought to treat motion sickness, yet it is featured on Amazon's motion sickness treatment section and is favorably reviewed by over a thousand users.

Unfortunately, in the U.S. now, users of medications must be very aware of the source and quality of the products they put in their body. Generic prescription medications and OTC products are highly likely to be manufactured out of the U.S. and with minimal oversight.

Where Are My Generics Made?

I take two generics: ramipril for my hypertension and rosuvastatin for my cholesterol/atherosclerosis and I had no idea where they came from until I called my St. Luke's pharmacist, Robert.

Robert told me that my 10-mg ramipril capsule was distributed by a company called West-Ward located in New Jersey. West-Ward was an independent Columbus, Ohio, company but was purchased in 2016 by a very large pharmaceutical company, , based in Aaman, Jordan. Now the Hikma website indicates West-Ward is no more and is simply called Hikma in the U.S.

According to a 2017 : "Hikma Pharmaceuticals Plc projects it will end 2017 with about $2 billion revenue, about $600 million of which is from generic drugs made by its U.S. subsidiary West-Ward. In the spring, the company had projected $800 million in generics sales."

Customer service at Hikma informs me that my ramipril was made in their Columbus, Ohio, plant.

My rosuvastatin (generic of Crestor) was made by Glenmark Pharmaceuticals which, , "is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons."

Glenmark received FDA approval to market generic rosuvastatin in the U.S. in July 2016. At that time, it had 115 products authorized for distribution in the US and 61 drugs pending approval with the FDA.

My rosuvastatin was made in India, according to Robert, although the does not reveal this information.

Generic Versus Brand Name

The development of a generic version of rosuvastatin (Crestor) has been very helpful for many of my patients. Looking online, generic rosuvastatin goes for about $10 per month compared to $260 for Crestor.

Is it worth paying an extra $250 per month to get brand-name Crestor if, let's say, it was manufactured in the U.S.? For most people it isn't. For one thing, there is no guarantee of where your brand-name drug is manufactured.

Crestor used to be made in a factory in Bristol, England, but this was and now I can't tell where AstraZeneca makes the stuff. Frankly, I'm surprised that they are selling any of the drug, which used to account for $5 billion of their annual sales.

So my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio, by a Jordanian company.

I never realized how globalized the pharmaceutical industry has become. Hopefully, the FDA is doing a good job of monitoring the safety and quality of products we rely on for our well-being that are manufactured all over the globe.

, is a private practice noninvasive cardiologist and medical director of echocardiography at St. Luke's Hospital in St. Louis. He blogs on nutrition, cardiac testing, quackery, and other things worthy of skepticism at , where a version of this post first appeared.