On July 15, 2018 we issued a People’s Pharmacy Health Alert: Valsartan Blood Pressure Pills Recalled Over Cancer Concerns. We tried to provide you, our faithful readers, the story behind the headlines. In a nutshell, the FDA followed the lead of drug regulators in Europe, Canada, Japan, Hong Kong and Taiwan by encouraging the recall of certain generic forms of valsartan. This heart and high blood pressure medicine was contaminated during manufacture with a carcinogen called NDMA. The affected valsartan came from a Chinese manufacturer. Companies that have been affected by the voluntary valsartan recall in the U.S. include Teva’s Actavis, Major Pharmaceuticals and Solco.
The Valsartan Recall Gets Murkier:
The Valsartan recall has opened Pandora’s box. There are questions about Chinese manufacturing of generic drugs. Then there is the whole issue of FDA oversight of foreign generic drug manufacturing. What are the implications for U.S. patients?
When Was the Valsartan Problem First Discovered?
If you read the news stories about the valsartan recall you might get the impression that this is a brand-new problem. Here is the official FDA New Release updated on July 17, 2018:
“The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is 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.”
We highlighted the last sentence. One might assume that this “unexpected” problem recently occurred because of “changes in the way the active substance [valsartan] was manufactured.”
The FDA commissioner goes on to say:
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market.”
When Did the Valsartan Problem Start?
It is not clear when valsartan was first contaminated with the carcinogen NDMA. Here is what we found in a July 17, 2018 Reuters health news release by Ben Hirschler:
“A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said on Tuesday.
The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could potentially have been exposed to cancer risk.
The European Medicines Agency (EMA), which first raised the alarm over the Chinese supplied valsartan on July 5, said it was now working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA.”
How Many People Were Exposed and for How Long?
If the Reuters article is correct and the problem with the Chinese manufacturing of valsartan dates back to 2012, this is an even bigger scandal than we first imagined. As we reported in our July 15 Special Health Alert, millions of people take valsartan daily to control high blood pressure and treat heart problems.
Here are some other questions we would like the FDA to answer:
- When did Zhejiang Huahai change its manufacturing process?
- Was the change approved by the FDA?
- Did the FDA review and test the “new” valsartan made by Huahai?
- What kinds of testing does the FDA require for detecting potential carcinogens in the manufacturing process?
- How does the FDA verify that pharmacies are recalling tainted products?
- Will patients have to pay for new valsartan or will the manufacturers of recalled valsartan provide refunds and quality substitutes?
- How will the FDA prevent a shortage of valsartan now that a major manufacturer has recalled so many pills?
- Can the FDA guarantee that other Chinese manufacturers of generic drugs are producing quality products?
Readers have responded to our Valsartan Recall Alert:
We have heard from many people about the valsartan recall. Here are just some of the comments we have received:
Abigail in Texas says:
“Either the FDA or big pharma needs to provide an opportunity to test our leftover valsartan pills for trace amounts of NDMA to ease all of our minds.”
Ellen in California wants to know why country of origin is not on the drug label:
“I do not understand why something we swallow does not have to be labeled as to country of origin when something we wear (clothing) does.”
Dorothy in Lake Havasu City, Arizona, is worried:
“Thank you for putting this information out as soon as you heard about it. I have been taking generic valsartan for years. My present prescription says: MFG. Solco, one of the recalled ones. I am one of those people who do not like taking prescriptions, but have to take BP meds. Needless to say, this frightens me.”
David H in Monroe, Louisiana, poses a key question:
“RE: Valsartan recall:
“Getting conflicting info from local pharmacies. Due to different insurance, my wife and I use different pharmacies. Both of us have valsartan by Solco. Her pharmacy says the recall is by lot number and she is ok. My pharmacy says recall is by manufacturer regardless of lot and is sending me a replacement. Any info as to who is right?”
To answer David’s question: His pharmacy is correct. The recall is by manufacturer. As far as we can tell, all lots of Solco valsartan have been recalled. His wife’s pharmacist was blowing smoke.
You can learn more about the valsartan recall at this link.
We have been writing about foreign-made generic drugs for quite some time. Our book, Top Screwups reveals serious flaws in the generic drug approval process.
You may also want to check out a book titled ChinaRx: Exposing the Risks of America’s Dependencer on China for Medicine by Rosemary Gibson and Janardan Prasad Singh. Here is a link.
Share your thoughts on the valsartan recall in the comment section below. Do you agree with us that this could be a bigger scandal than we originally imagined?