No, no, no, no no! Not again!! Just last week we said “Not Again” when we learned that that some formulations of the blood pressure drug irbesartan were contaminated with the impurity NDEA (N-nitrosodiethylamine). This probable carcinogen had been introduced during manufacture of the ARB (angiotensin receptor blocker). The active pharmaceutical ingredient (API) was made in India by Aurobindo Pharma Limited. Before that, there was a valsartan recall. And now there is a losartan recall. What the heck is going on?
Generic Cozaar | Losartan Recall
We are told that another generic ARB, losartan, is being withdrawn because of concerns about a probable carcinogen introduced during manufacture. This is getting ridiculous! On November 9, 2018 we discovered that the:
“FDA is alerting patients and health care professionals to Sandoz’s voluntary recall of one lot – JB8912 – of losartan potassium and hydrochlorothiazide 100mg/25mg tablets, that contain losartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic, used in combination for the treatment of hypertension. Sandoz’s product was made using an active pharmaceutical ingredient (API) that has tested positive for NDEA. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.”
So far, the FDA reports that “less than 1 percent of the total losartan drug products in the U.S. market” have been affected by the losartan recall. That might seem reassuring, but the valsartan recall started out seemingly small. It grew and grew until we lost count of the number of companies that were affected. We will be very interested to see whether this losartan recall spreads like the valsartan recall.
The Cast of Characters:
What is especially bizarre about this new warning is the cast of characters. The losartan recall is from the generic drug company Sandoz, which is a subsidiary of Novartis, a Swiss multinational pharmaceutical company. The active pharmaceutical ingredient (the real medicine) was made in China by Zhejiang Huahai Pharmaceutical Co. Ltd., the same Chinese company that made the contaminated valsartan.
We issued a special People’s Pharmacy Health Alert back oh July 15, 2018 because of cancer concerns. At first it seemed like a relatively small recall, but over the summer the FDA issued more announcements about recall after recall. More manufacturers were caught up in the web.
China at the Center of the Storm!
The Zhejiang HuaHai Pharmaceutical Company in Linhai, China made the valsartan that was distributed to other drug manufacturers all over the world. Regulators in Europe, Japan, Hong Kong, Taiwan, Canada and the U.S. ordered recalls of various valsartan products. Here is a list of manufacturers that had problems with their valsartan products.
But Wait…It Get’s More Complicated.
The finished losartan pills that were recalled by Sandoz were not made in China. They were actually formulated in Ljubljana, Slovenia by Lek Pharmaceuticals dd. This company took the API losartan from Zhejiang HuaHai in China, added hydrochlorothiazide from goodness knows where and turned these chemicals into Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25 mg. The Lek Pharmaceutical company presumably shipped its pills to Sandoz, which then shipped them to distributors which then shipped them to U.S. pharmacies.
Are your confused?
You should be. You have to read the FDA’s official announcement to appreciate this bizarre system of drug manufacturing. Here is a link to the FDA’s announcement.
What you are learning is that our medicines are being made all over the world. We suspect that a drug made in China, shipped to Slovenia and then shipped to the U.S. might not get the same FDA scrutiny that a medicine made in Pennsylvania might get.
We also worry about the way inexpensive generic drugs are transported. We have repeatedly asked the FDA if it monitors shipping conditions abroad. The answers we have received are unsatisfactory. Are medicines shipped in temperature and humidity controlled containers? Are they shipped by airplanes or cargo ships? The FDA has not answered our questions in a clear manner. We find that distressing.
Here is an article we have written about the FDA’s answers to our questions about shipping both from abroad and within the U.S.
The People’s Pharmacy Perspective:
We are sick and tired of reading about another ARB recall. We now have the valsartan, irbesartan and losartan recall to contend with. We shall see if more ABRs enter the contamination contest. At the rate we are going we would not be surprised to learn about others.
You may find our interview with Rosemary Gibson of great interest. Her book is titled: China Rx: Exposing the Risks of America’s Dependence on China for Medicine. Here is a link to a one-hour interview on this topic. We think you will find it fascinating. You can listen to the streaming audio for free by clicking on the green arrow above Rosemary’s picture. You can also download the mp3 file for free to play on your computer or electronic device. Here is the link.
We Value Your Opinion
What do you think about the ARB recalls? Share your own thoughts about the manufacturing of generic drugs in countries like China, India and Slovenia. The FDA continues to try to reassure physicians, pharmacists and patients that it has everything under control. The FDA says generic drugs made abroad represent a great savings for Americans. Do you agree?