By now you have read a lot about the valsartan recall. Many lots of the common blood pressure pill, valsartan, have been recalled. Initially, the FDA issued recalls for valsartan from just three manufacturers: Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutical Industries (with valsartan labeled as Actavis LLC).
Now the recall has been expanded to include valsartan and combinations of valsartan and hydrochlorothiazide from other companies including Remedy Repack, A-S Medication Solutions and AvKARE.
All of these valsartan products may contain an active pharmaceutical ingredient manufactured in China and contaminated with N-nitrosodimethylamine, or NDMA. This compound is a probable human carcinogen.
How Big Is the Valsartan Recall?
It is hard to get a handle on the immensity of the valsartan recall. The FDA has been fairly tight lipped about how much of this generic drug has been recalled. One expert we consulted suggested that this could be the biggest consumer recall in history.
Valsartan is taken by roughly three million Americans. Millions more take it worldwide.
According to the Globe and Mail, a major Canadian newspaper:
“There were more than 2.5 million prescriptions for the drugs involved in the recall dispensed in Canada last year, according to IQVIA, a company that tracks the pharmaceutical industry. That represents more than half of the total 4.4 million prescriptions dispensed for valsartan drugs in Canada, according to the IQVIA data.”
If half of the valsartan sold in Canada has been recalled, that could mean a huge number of pills have been recalled in the U.S. and Europe as well. Our expert consultant could be right. This could be the greatest consumer recall in history.
The Food and Drug Administration keeps updating information on the valsartan recall. Since the July 27th update we now have an August 2, 2018, update. In addition to the companies listed above the FDA now states:
“The following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:
• Bryant Ranch Prepack Inc.
• H. J. Harkins Company Inc. (this company was not originally included on either list)
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals Inc.
• Northwind Pharmaceuticals
• Proficient Rx
“It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.”
How Dangerous Is NDMA?
“NDMA has been found to increase the occurrence of cancer in animal studies.”
The agency goes on to downplay the risk to humans, however.
“Consuming up to 96 nanograms NDMA/day is considered reasonably safe for human ingestioni. It is estimated that over the course of a person’s lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime.”
Lest you develop a false sense of confidence, FDA goes on to say:
“The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years.”
Yikes! Some people may have been swallowing a pill every day for four years that contained a probable carcinogen. The FDA did some calculations and concluded that only one person out of 8,000 would develop cancer as a result of the contaminated valsartan. We’re not so sure about this assessment. We doubt that anyone will be required to actually follow up on the millions of people exposed to contaminated valsartan. Consequently, we may never know how many people were affected by this gigantic manufacturing error.
The FDA’s Final Words of Wisdom:
“Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.”
You can read more about the implications of the valsartan recall at this link:
You may also wish to listen to our radio show about valsartan and other drugs made in China. It will be broadcast initially on August 4, 2018. The podcast will be available on Monday, August 6, 2018 at this link.