The People's Perspective on Medicine

Critical Shortages Resulting from Recalled Valsartan Are Expanding

Have you overdosed on recalled valsartan announcements? We wouldn't blame you. We've counted 565 recalled valsartan lots. Now there are valsartan shortages!

Over the last six months the FDA has announced numerous recalls of blood pressure medicines. You can read about them here on the FDA’s website.  We wouldn’t blame you for zoning out. There have been so many it has become ridiculous. On 1/23/2019 the FDA headline was “Torrent further expands its voluntary recall of losartan.” On 1/18/2019 the FDA’s headline was “Irbesartan distributed by Solco Healthcare voluntarily recalled.” On 1/3/2019 the FDA writes, “Torrent expands its voluntary recall of losartan.” And on 1/2/2019 the headline read, “FDA alerts patients and health care professionals to Aurobindo’s recall of valsartan medication due to NDEA.” The last notice of recalled valsartan involved 80 lots. That represents at least 20,000 bottles of pills. That’s just in January and does not include the preceding months.

How Many Recalled Valsartan Pills Are Bad?

The FDA does not count the number of pills involved in recalls, but we suspect that number could be in the hundreds of thousands or even millions. All we know is that our count, based on the FDA’s website, is 565 recalled valsartan lots. These lots may have lots of bottles in each lot. Some of these bottles contain 1000 pills in each bottle. Do the math. That is a LOT of bad pills.

That’s just recalled valsartan. It does not include recalled lots of losartan or irbesartan.   We suspect this could be the largest drug recall in FDA’s history.

Recalled Valsartan And Shortages

As a result of all the recalls, the FDA has just announced that there is a shortage of valsartan. Here is the FDA’s statement. It is long and a bit overwhelming. Here are a few highlights:

“Last summer, the FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards. ARBs, including valsartan, irbesartan, losartan and others, are a class of medicines used to treat high blood pressure and heart failure. Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), are probable human carcinogens.”

“We know patients rely on these medicines. Part of our work throughout this process has been to mitigate and prevent shortages, where possible. Currently, valsartan products are in shortage, and we know that other types of products may fall into shortage soon.”

Don’t Worry Be Happy

Related drugs such as losartan and irbesartan are likely to be in short supply in the future. The FDA maintains that the overall risk is low. Don’t worry. Only one person in 8,000 is likely to develop cancer because of this snafu. But we are not happy campers. I personally take valsartan. My last prescription was from Aurobindo. I have yet to hear from my pharmacy. Nitrosamines are nasty chemicals. I do NOT want them in my pills!

Sadly, we will never actually know how many people will develop cancer as a result of this disaster. It is highly unlikely that the FDA will sponsor the kind of research that might tell us. We sincerely doubt that the Chinese company will sponsor such a study. This kind of research has to involve a great many patients and will have to last for decades. It takes a long time for cancer to develop from carcinogen exposure.

People who cannot get supplies of their usual prescription blood pressure medicine may need to ask their health professionals about alternatives. You can learn more about some other ways to lower blood pressure in our guide to Blood Pressure Treatment.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I take Atacand generic which is Candesartan, is it also on the watch list? Why can they not make a medicine that does not have killer side effects.

So far candesartan has not been identified as contaminated.

Hi,
I take Losartan. When I asked my doctor about the FDA’s recall of the above drug, he said that the problem was with only one batch, which has been withdrawn from the market. Meanwhile, because of my neck and back pain (for which I’ve been operated on several times) I still sometimes have very high blood pressure. I drink a glass of beat powder mixture, and within an hour my pressure normalizes. Can I use this natural remedy instead of Losartan? No use to ask my doctor. He does not believe in natural remedies.
Thank you.

The trouble with trying to substitute beet powder is that you would have to take it at least twice daily and keep close (daily) tabs on your blood pressure.

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