Tag Archives: valsartan

Is Your Generic Medication Made In China and Is It Safe?

Last week the FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen (see here.)

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 which I will copy 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 recent article 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, “China RX: Exposing the Risks of America’s Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh,” details the problem.

It is very hard to find out how many US drugs come from China since 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 OTC medications. I realized this when I looked closely at this “motion sickness patch” which is highly rated on Amazon.

It has no active ingredient which could be realistically thought to treat motion sickness yet is featured on Amazon’s motion sickness treatment section and is favorably reviewed by over a thousand users.

 

Unfortunately, in the US 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 US and with minimal oversight.

Skeptically Yours,

-ACP

If You Are Taking Valsartan Read This

The FDA issued a press release July 13 announcing the voluntary recall of several drug products containing valsartan.

Valsartan is a generic, commonly used member of the drug class of angiotensin receptor blockers (ARBs) used for high blood pressure and heart failure and I have many patients on it. The brand name form of it (Diovan) does not appear to be on the recall list.

Per the FDA, the recall was

due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

If you are taking it read the following from the FDA to see if your particular manufacturer is included in the recall.

If your valsartan has been recalled contact your doctor for instructions. For my patients, most likely I will substitute another ARB called losartan which has very similar effectiveness and side effects.


Information for Patients and Health Care Professionals From The FDA

  • Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Recalled Products

Medicine Company
Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.


-ACP