The People's Perspective on Medicine

Another Day Another Losartan Recall | Can We Trust the FDA?

Are you one of the millions of people taking an ARB for hypertension like losartan or valsartan? Did you know there's a NEW losartan recall? Are you fed up?

Are you becoming numb to FDA generic drug recalls? We wouldn’t blame you if you were. The ARB debacle came to light on July 5, 2018. That’s when the European Medicines Agency (EMA) started warning countries that Chinese-made valsartan was contaminated. A probable carcinogen was detected in this API (active pharmaceutical ingredient). Millions of people were impacted all around the world because the Zhejiang HuaHai Pharmaceutical company in Linhai, China, supplied valsartan to lots of different drug companies. Then we were notified that a similar drug, losartan, also had contaminated batches. This week the FDA announced yet another losartan recall.

What Is an ARB?

Two of the most successful blood pressure medicines in modern times are ACE inhibitors and ARBs. ACE stands for angiotensin converting enzyme and ARB is an abbreviation for angiotensin receptor blocker. They have a somewhat similar mechanism of action.

At last count, over 10 million people filled more than 50 million prescriptions for drugs like losartan (Cozaar) and valsartan (Diovan). ACE inhibitors were even more popular. Twice as many patients filled over 100 million prescriptions for drugs like lisinopril (Prinivil, Zestril), enalapril (Vasotec), benazepril (Lotensin) and ramipril (Altace). If your medicine has a “pril” in the name it is likely an ACE inhibitor. If it has an “artan” at the end it is probably an ARB.

How Do They Work?

By now you have figured out that ARBs and ACEis work by affecting the chemical angiotensin. It is a critical component of the body’s intricate system for regulating blood pressure. If you suddenly lost a lot of blood because of an accident, your kidneys would release a chemical called renin.

Renin facilitates the production of angiotensin I. The enzyme called ACE changes angiotensin I to angiotensin II. This compound constricts blood vessels and raises blood pressure. If you inhibit the formation of ACE you lower levels of angiotensin II and dilate blood vessels and lower blood pressure.

An ARB works a bit differently to accomplish the same result. Drugs like losartan and valsartan block the action of angiotensin II at the cellular level. Think of an ARB a bit like bubblegum that is jammed in a keyhole. When the key (angiotensin II) tries to fit in the lock to cause vasoconstriction, it can’t turn. This leads to vasodilation and reduced blood pressure.

Losing Count of Recalled ARBS:

As you may remember, the first ARB recall (for valsartan) was in July, 2018. Since then there have been so many valsartan recalls that we have lost count. Here are just a few articles we have written on this topic:

Valsartan Blood Pressure Pills Recalled over Cancer Concerns

Valsartan Recall Update: How Big Is The Problem?

The Valsartan Recall Disaster Keeps Getting Worse, Not Better

Chinese-Made Losartan Recall | More Cancer Concern

Do You Have Any Idea Where Your Pills Are Made?

Irbesartan Is Contaminated with Probable Cancer-Causing Compound!

The First Losartan Recall:

On November 12, 2018, we wrote:

“no, no, no, no, no! Not Again!. Just last week we said “Not Again” when we learned that some formulations of the blood pressure drug irbesartan were contaminated with the impurity NDEA.”

In this case, the irbesartan was made by the Indian pharmaceutical company, Aurobindo Pharma Limited.

Then losartan was targeted. The active pharmaceutical ingredient was made in China by Zhejiang HuaHai, the same company that made the contaminated valsartan. But wait, it gets crazier. The pills were actually formulated in Ljubljana, Slovenia by Lek Pharmaceuticals for Sandoz, a familiar drug company. Read the FDA’s official notification to appreciate how bizarre this is.

The Latest Losartan Recall:

Hop on the merry-go-round with us because here we go again and again and again. On December 20, 2018, the FDA announced that:

“Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.”

The FDA goes on to point out that NDEA is a probably carcinogen.

Here is what Torrent Pharmaceuticals LTD tells us about itself:

“Torrent Pharma, the flagship company of the Torrent Group, is one of the leading Pharma companies in India. Conceived as a small generic company in the early ’70s by Late Shri U N Mehta, Torrent Pharma blazed a new trail in the Indian pharmaceuticals industry by successfully implementing the concept of niche marketing. With significant presence in more than 40 countries, Torrent is all poised to spread wings across globe with strong technical capabilities and international accreditations. To enable strategic differentiation, Torrent Pharma’s international business is segregated into US, UK, Germany, Europe, Brazil and Rest of the World.”

If you read the FDA’s statement carefully you learned that the losartan recall was for Torrent’s 100 mg pills. But the active pharmaceutical ingredient (API) was actually made by Hetero Labs Limited. What do we know about Hetero Labs?

In its own words the company states:

“Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Backed by over 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Generics, Biosimilars, Custom Pharmaceutical services and Branded Generics.”

“Hetero has a strong global presence in over 126 countries and focusses on making affordable medicines accessible to patients worldwide.”

The losartan recall is not the first time that Hetero Labs Limited has gotten into trouble with the FDA. A warning letter was sent to Dr. Reddy, Chairman and Managing Director of Hetero on August 15, 2017, by Jason Chancey, Consumer Safety Officer for the FDA.

“Dear Dr. Reddy:

“The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hetero Labs Limited, Unit V at Polepally Village, Jadcherla Mandal, Mahaboob Nag, Telangana, from December 7–16, 2016.

“This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP [current good manufacturing practice], your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).”

Here are just a few of the FDA concerns:

“Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

“Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).

“Your firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.”

People’s Pharmacy Perspective:

We have reached the limits of our patience with FDA’s oversight of generic drugs made abroad. You can listen to an interview we conducted with Rosemary Gibson: Show 1131: Was Your Medicine Made in China?

The one-hour interview is free. You can listen to the streaming audio by clicking on the green arrow above Rosemary’s photograph. At the bottom of the page you will see the heading “Listen to the Podcast.” You can download the mp3 file for free. Do not be confused by the price $9.99. That is for the CD. If you toggle the arrow to the right of Choose CD or MP3 Version you will see that you can access the free MP3 version of the show. The price changes instantly to $0.00. Just add it to your cart.

If you find this information of value, why not subscribe to the FREE podcast of our syndicated public radio show. Here is a link. Just click on View in iTunes under our photo and then click subscribe under our photo.

Thanks for supporting the People’s Pharmacy with your free subscription.

In our book, Top Screwups, we have a whole chapter devoted to our investigation into the generic drug disaster that has evolved over the last decade or so. It is called Generic Drug Screwups. We think you will find it enlightening. We investigated the FDA and discovered some shocking revelations. We do offer our Top 10 Tips for Taking Generic Drugs in the likely event that your insurance company requires you to take a generic medicine.

Please comment on the latest generic losartan recall in the comment section below.

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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’m starting to wonder if the reason why so many of us have blood pressure problems is this crummy economy and all the stress a lot of us are under just to make ends meet. There used to be a time when only one parent working full time could reasonably expect to be able to support an average sized family of 4. Now it seems like both parents have to work full time, and even then it seems like it’s often still not enough. Not sure how our economy went so pear-shaped. Also those of us who are single but have a lot of debt, with student loan debt comprising the bulk of it, have a similar problem: working full time but still having trouble making ends meet.

Having deleted the 3-5-19 People’s Pharmacy article regarding the FDA, today is a Red Letter Day! Mr. Gottleib has resign, and so hopefully medicines, contaminations, and the FDA conglomerate, will take a turn for the better. Great move on the part of the President. It is only a beginning, but a step in the right direction.

I agree with Carol in Milwaukee, I’m taking Losartan 50 mg from Torrent. I understand this recall is for the 100 mg, but I don’t feel real confident that this dose, 50 mg by Torrent is safe. When is this going to end?

I wish you had included Irbesartan in your headline. That was the relevant information for me. I was taking losartan, but my blood pressure specialist switched me. She said losartan isn’t a very good BP medication. Now I’m wondering who to believe about the recall of Irbesartan. Can I trust CVS Caremark to tell me that what they sent isn’t contaminated?

I took Valsartan for over three years and I currently have lung nodules that have been followed for two years. I’d like to know just what this drug causes, as far as
damage to an organ system., etc.,,. I’m not a smoker and never have been, I just
hope my nodules aren’t related to having taken this medicine.

We keep hearing about the problems with drugs manufactured in China and India, but there is no attempt to stop importing these questionable sources.

Think of all the big pharmaceutical companies that once produced medications for Americans in the United States. Not only did the FDA do a better job of monitoring these drugs, but it also employed many more Americans with good paying jobs with benefits.

Now it’s all about the bottom line with no concern about the consumer.
I’ve been taking Amlodipine and Atenolol for years, with horrible side effects. Most doctors say it’s fine. Recently I had a cardiologist try to switch me from Atenolol to Motropolol. It was very difficult and he decided I must stay on the Atenolol.

No insurance company is willing to pay for the original product. We must take the generic or pay a high premium. Our health care system is a mess, and it’s not the fault of the Affordable Care Act; it’s the greedy drug companies and insurance providers.

When is this country going to wise up and stop buying drugs from foreign countries? I am on Losartan, and so far where my product was made hasn’t been recalled. Is that because there isn’t a problem or because there aren’t enough resources to check out this company?

I wished I could get off this med totally. However, I tried many times, and no matter how many of the natural ways suggested to lower BP (including a lot of exercise) it just doesn’t work for me. Of course the big question is: “What is normal for the various age groups?” I believe that big pharm is controlling these numbers to sell pills. I ask my doctor that if 150 systolic is harmful then why should I exercise as my systolic goes much higher than that during my workout sessions. He says its for a shorter period of time. Pressure is pressure to me, and a short burst of high blood pressure can be as harmful as long term. Who is right? Is BP in the 140s and 150s normal for older people?

The FDA is in the pockets of the Pharmaceutical cartel! A sham at best, felonious conduct at worst! What is masquerading as healthcare in this country is little more than a “Treatment Industry,” peddling the poison that the cartels produce!

I’m taking Losartan Potassium 50 mg. I realize this recall is for the 100 mg but how confident can I feel assuming this dose, by Torrent Pharma, is safe?

There are several corrupt (subject to lobbying or other nefarious interventions) federal agencies, e.g. FDA, HUD , DEA , USDA and Interior, that do not seem to notice their purpose is to protect the public. I’m glad you are a watchdog for the FDA.

I don’t use a pharmacy because we have a wonderful clinic at work which supplies my Losartan. Can I trust that they will be notified of a recall if their source is involved?

This is not the first time I’m complaining to the People’s Pharmacy about Losartan and the terrible side effects I’ve suffered taking it for 4 years in the SPRINT study. Finally, when the study was complete I stopped it on my own because I developed horrible rashes, itching, and so on. After a recent blood test the doctor found one of my liver enzymes is not normal so I have to have a complete liver workup. We need to do something in this country to see that these poorly-made drugs are kept from our population. Made in America is what I want to see for all prescription drugs.

Just one of many reasons I’m very thankful that I don’t take any pharmaceuticals! However, I do take vitamins which may be equally concerning. Who knows where the raw materials come from? Eeek!

In the case of Hetero Labs previous violations: If violations were found upon inspection in December 2016, why in the world would it take until August of 2017 for them to receive a warning letter?! So that means they continued to produce the product using faulty processes for at least eight more months? That’s insane!

I’m sorry, but I hate generic drugs. They are not as effective as brand drugs. Big Pharma wants to make lots of money at the expense of the general public. And at this point our government won’t protect its own. It’s time people get on board with this and start to make a fuss over this. Really, this is killing our people, and it must stop.

The status of this drug manufacturing disaster is nice to know but telling us how to avoid getting an adulterated prescription would be much more useful. Here are a few questions:
How can we know our prescriptions are safe?
Is there a brand or alternate source that is safe?
If so, how can we be sure the prescription is being filled with the safe alternative?
Are they ALL unsafe if they have these ingredients in them?
Are we better off to stop taking these drugs?

Harry,

We only wish we had nice simple answers to your very important questions.

This is so disturbing on many levels. As a volunteer provider at a free clinic for the uninsured, our best resource for medications for our patients is an organization that must rely on generics in order to provide the most medication to the most people. As a patient, it is difficult to trust generics, and yet name brand medication is wildly expensive. Profit margin over people’s health is a persistent travesty.

When will they start re-evaluating all the other drugs and ingredients made in China or, for that matter, made elsewhere? Even U.S. makers have been reprimanded in the past.

I think it’s time everyone woke up and understood that the whole system is about money, not the health of patients. You’d be far better off to try your hardest to live healthier. Health doesn’t come from drugs. They mask or alleviate symptoms, and ALL of them have side effects. These may sometimes be severe and even deadly. Additionally, all drugs must be processed by the liver and/or kidneys, and sometimes are very hard on those organs.

The answer to the question the article raises is NO!

The FDA is a joke!
I don’t trust our FDA at all!
They allow harmful drugs to be sold and refuse to sell helpful ones
It got so bad with my Mom and drugs she was prescribed that I started checking if her medecine was for sale in the U.K. and the EU.
If a drug was not available there odds are it was already recalled there or deemed to have to such severe side effects it was deemed to do mare harm than good and not allowed to be sold there.

How I wish the FDA would be more like what they have in the U.K. !
So many drugs that had been recalled here, were first recalled there sometimes up to a year in advance of it being done here!

Elizabeth That was a very helpful comment. Thank you

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