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

13 thoughts on “If You Are Taking Valsartan Read This”

      1. So, I am not a doctor, but I did read the medical literature to see if there was a comparison of the other medications in the same class with valsartan, and uniformly they indicated that valsartan was quicker and longer lasting than others in its class. Diovan, the brand name valsartan, is more expensive, but I think a doc can authorize its use particularly when the manufacturer of the drug is not in China where the FDA has no oversight over the manufacturing process which is what led to the recall. From what I can tell, Diovan has issued a co-pay card that brings the drug in line with the generic cost. Just a thought, anyway.

        1. Many years ago when ARBS were first coming out and brand name ARBS were all we had I did conclude that Diovan was superior to losartan, primarily due to longer duration of activity so that for most patients it could be given once daily. The data was also better for Diovan in CHF patients and so I tended to go with Diovan if patients developed a cough on ACEI inhibitors (i.e. lisinopril). When losartan came out as the first generic, however, I began using that primarily and watching for late BP spikes that would indicate patient needed to take it twice daily.
          Doctors have to jump through lots of hoops to get brand name drugs approved when there isn’t strong evidence supporting their superiority and even if approved, insurance companies can charge high co-pays.

      1. That is true, although I was able to find a medication discount card through Novartis which manufactures Diovan so the co-pay was the same. The downside is that it runs out at the end of the year.

  1. Greetings,

    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.

    1. Dear Frustrated,
      Excellent points. I agree with you entirely. Personally, I would never want to put in my mouth something that was made in China or Russia.
      I am putting together a post on a Chinese made OTC sea sickness patch that is clearly just hogwash. I’m sure there are thousands of other examples.
      I will post your comment as a new post on my sight to help highlight this issue.

      1. After my last comment, I started researching where generic drugs are generally manufactured which are distributed in the US. The vast majority come from China and India. It’s a multi-billion dollar industry for those countries. I also note that losartan was subject to 12 FDA recalls in 2017. While I do understand that the manufacturers have to get approval with the FDA to manufacture for distribution in the US, it is not clear what on-going oversight occurs except sort of random drug testing. Makes me a little queasy. While I understand generics are vastly cheaper than the brand names, it does appear that there is substantial risk from generics.

      2. I am a transplant patient. I looked at my medications and most of them were made by an Indian company, Lupin, which has had many serious violations per FDA and we continue to buy them. CVS Caremark is the mail order pharmacy which enormous number of persons get meds from.
        God help medicaid and medicare patients!

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