The People's Perspective on Medicine

Pharmacist Did Not Tell the Truth About Valsartan Source

With the expanded recall of valsartan from China, it makes sense to learn where your valsartan was made. This might be more of a challenge than it seems.

Over the past month, a recall that at first appeared quite limited in scope has continued to spread. The problem is with an active pharmaceutical ingredient made in China that was contaminated with a probable carcinogen. Initially, the FDA named just a handful of companies that were affected by this recall, but more companies were added over time. That has plenty of Americans wondering where their valsartan was made. It isn’t always easy to tell.

Learning Where Your Valsartan Was Made:

Q. I received a call from my pharmacy that my blood pressure med valsartan was being recalled. They replaced it with a safer alternative. When I picked it up, I specifically asked the pharmacist if the valsartan was made by a U.S. company and if it had been manufactured in the USA.

She was emphatic that the Macleods valsartan was from a U.S. company and the pills were made in the United States.

When I got home I got out my magnifying glass and discovered that the pills were “manufactured for Macleods Pharma USA, Inc.” The address was Plainsboro, NJ. That was reassuring until I looked a little closer. The label also stated that my pills were “Manufactured by Macleods Pharmaceuticals Ltd. Damon (U.T.) INDIA.” Shouldn’t the pharmacist have told me the truth?

Did the Pharmacist Check Closely Enough?

A. It is not unusual for foreign pharmaceutical companies to have U.S. subsidiaries. According to the company, Macleods Pharma USA is the U.S. division of Macleods Pharmaceuticals, LTD, based in Mumbai, India.

According to the FDA, this company’s valsartan products are “not currently recalled.” That means they should be considered a safe alternative.

Why Didn’t the Pharmacist Tell the Truth?

We do think the pharmacist should have been truthful and told you that the parent company was in India. She should have added that the pills were made there. Perhaps she had not taken the time to look it up, so she just assumed Plainsboro, NJ, meant that the valsartan was made in the USA. When asked, however, she should have dug deeper and found the real source.

How Times Have Changed!

Not that long ago most of the medicines dispensed in the United States were made in the United States. Over the last two decades, however, a great deal of pharmaceutical manufacturing has moved abroad. Guess why? Right as always. They are cheaper to make abroad.

Most people never bother to think about where the chemicals in their pills are made. The active pharmaceutical ingredient (API) is the key component of any medication. Then come the fillers, binders, coloring agents and other assorted compounds that create a pill. These are collectively called the excipients or nonactive ingredients.

The API could easily be made in China. The excipients could be made there too, or in Thailand, Croatia, Brazil or India. The place where the ingredients are mixed together and formulated into a pill, capsule, tablet, inhaler or ointment could be in another country entirely. Trust us when we say the manufacturing of drugs is a closely kept secret.

The one thing we can determine is the country where they are put into final form. With so many recalls and scandals within the generic pharmaceutical industry over the last decade, people have a right to know where their medicines come from. And we think pharmacists have a responsibility to share that information accurately. Maybe there should be a law that country of origin be prominently displayed on the label.

What Do You Think?

Should the pharmacist have taken a few minutes to verify the country of origin before handing the pills over to this patient? What if the patient wanted valsartan made in the USA? Should the pharmacist have tried to locate some? What if the chain drugstore only supplies the least expensive valsartan from abroad that has not ended up on the FDA’s no-no list?

We would be interested in your perspective on this. What would you do if you discovered that all your medications came from abroad? Do you trust the FDA to verify they will be identical to the branded products? Would you be willing to pay a little more for pharmaceuticals made in the United States?

Share your thoughts in the comment section below.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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I definitely would pay more for drugs made in USA or a country whose manufacturing standards are reliable and similar to ours.

My initial prescription for Valsartan was probably okay and I took them for years. Then the pharmacy changed it to the Chinese company that is in the forefront of the recall and the pills looked different. Yet we cannot assess drugs from Canada. I don’t get it.

Bottom line: I would prefer drugs made and sourced in the USA ONLY! The FDA barely monitors US companies. There’s no way they can monitor or regulate foreign manufacturers! All drugs sold in U.S. should be labeled as to country of origin for all ingredients! We need Congress to pass a LAW to that effect ASAP!

In regard to the source of active drug ingredients and some generic drugs, one might wish to read the excellent book “China Rx: Exposing the Risks of America’s Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh.

The pharmacist was either over worked, careless, lazy, or naive . Take your pick. I use a local pharmacy where I know the the individuals . No impersonal mail order suppliers, that the big chains are trying to push us into. They are often dishonest. I have found that the cash price is sometimes better than their part and the the deductible!

Knowing a little about the pharmaceutical industry since I work for a wholesaler, the pharmacies we manage have what they call a formulary (what drugs they carry in stock). When they buy drugs off formulary they get reprimanded for not being in compliance. Manufacturers of drugs can change on the formulary because the source demanding the compliance will find a cheaper alternative. However, it is researched that the drug switched to be an equivalent.

Absolutely, the country of origin should be prominently displayed on the drug’s label. I’ve noticed that information is readily available on packaged food, so why not drugs? Likely because the food companies aren’t as rich and powerful as Big Pharma. The FDA is worthless. The whole situation with bad medicine and money hungry doctors is sickening.

My Chinese friend won’t buy any food product made in her own country.

Anything that affects the physical and mental health of a population ie: food, water, medication, should be under the protection of a homeland security type agency. Something having such a powerful effect on health and behavior such as medicine should be manufactured here in the states. Based on what I have read I have little faith in many of the government agencies that are supposed to “protect” our health. That being said, to allow the manufacturing of our medications to be sourced out to other countries exposes our citizens to the perils of questionable practices as is evidenced by the current Valsartan recall. Clearly, a dangerous ball has been dropped in an effort to save a few dollars.

It needs to be mandated (will probably have to be done on a state by state basis through rules promulgated by that state’s Board of Pharmacy) the origin of the raw ingredients AND where the tableting (manufacturing) process takes place. So the label would read” raw materials from India, China, Ireland etc… and manufactured in England, USA etc…”. These labels need to be required on the stock bottles and this information also needs to be on the prescription vial itself as part of the label. And no drugs should ever come into the United States from a source that is not FDA inspected and this includes Canada. It is very difficult to find where raw materials originated – often the companies have multiple sources and each lot may indeed come from a different source of origin. Let’s make it all “made in the USA.” Ellen Breed, PharmD

GMP (Good Manufacturing Practices) is a quality issue for any company. There are national and international standards describing such operations. That’s why, when investigating any company, check their quality statements and adherence to standards. That will tell you quite a bit. Many of the smaller companies, and even major ones overseas, do not have quality recording software systems to help them maintain their own standards. Insist on it!!

Also, how about changing lifestyles to get completely off drugs? In my opinion, the pharmaceutical companies don’t want to cure you, they only want to treat the symptoms, and keep you on a prescription for the rest of your life!! Check it out.

First off, Consumer Reports is NOT consumer friendly when it comes to the medical field. Take them with a grain of salt; also research other sites.

Secondly, any type of drug given here in the U.S. should be made/manufactured here in the U.S. I personally feel drug manufacturers moved operations abroad to skirt our laws, in addition to thinking they’re saving money. In the long run, what do they actually save if their product is recalled?

Now I read that HCTZ 12.5mg is being recalled as the manufacturer instead substituted Spironolactone (sp) without telling anyone. Any wonder us consumers become so distrustful of the pharmaceutical field when this happens?

I signed up for FDA recalls and checked the medical box; am I surprised over the number of recalls not only on pharmaceutical products, but diagnostic equipment used in hospitals. It’s a real eye-opener on how our health is compromised. That’s why I am so thankful/grateful for The People’s Pharmacy and the work the Graedons are doing.

It’s bad enough to be 80 and under three different doctors’ “care” for different elements of one “system”, and being unaware of what’s causing what I’ve heard described as “Polypharmacy”, dumping an eggcup full of pills morning and evening. No help from the medics in trying to figure it out.

And on top of it all, not knowing whether or not these foreign substances have been manufactured/composed of the “advertised” compound or compounds?

Where is the so-called “medical profession” in all this?

Where are our “elected representatives” who, supposedly, are looking out for our interests?

I am NOT willing to pay more for drugs made in the USA. They cost too much now and in many cases the list of side effects are worse than the reason they are prescribed.
I have a right to expect my medicines to be safe. When something like this is discovered the US government should sue the eyeballs out of the executive officers of the company and hold them PERSONALLY responsible as well as the company itself. This would go a long way towards quality control in a crucial area of medicine. Unfortunately, the political connections of these international corporations allows them to get rich at our expense and we are left twisting in the wind. I have no tolerance for any of this, especially considering that they sell these drugs cheaper in other countries while they rob patients in the US.

I take Losartan. With the recall of valsartan I wanted to see where my drugs were manufactured. I happened to have 2 generics in my cabinet, one being a new refill. I called CVS. The pharmacist could only find the location of one of the drugs which came from India although it had a US drug company on it until you probed further. She could not find the origin of the other generic pill. She gave me the phone number for the drug company. I called and they would not tell where the drugs where manufactured. They said it was basically secret and they didn’t have to tell me. I checked on a government website and the drug companies do not have to make the country of origin public knowledge. I am appalled by this. How do you regulate a drug made in China or India or for that matter any foreign government? This needs to change!

I did some research about Valsartan/Express Scripts(Camber) and they are manufactured in India. I also found out that this formula has been on the market since 2012. India (Hetero) changed the formula and added in this carcinogenic additive a little less than China in 2012. So for those of you including myself who have been taking this for such a long time I wish ourselves good luck. Again, the FDA has been doing a pitiful job. It’s really disgusting. Hope that Losartan doesn’t have the same garbage.

I’m wary of foreign made drugs but doubt I could afford made in US drugs. I recently picked up a generic for metoprolol & for the 1st time the drug store had listed the mfg. I researched the mfg and discovered they had had numerous recalls and were having trouble passing FDA inspections. Of course the drug store said that since I’d left the store, I couldn’t return the meds. I’m taking the 90-day supply hoping I dodge a bullet.

I’m 70 and I discovered some “certified” drug suppliers in Canada and have been satisfied thus far. In many cases the drugs are cheaper than my co-pays with insurance in Texas. The company gives you options from different country of origin. I usually select Canadian made but understand from your article that various ingredients may be sourced from anywhere.

Unfortunately, due to many medical issues, I take a combined total of 17 different medications daily, not including vitamins. I will now inspect each bottle, tube, and vial to locate the location of manufacturer. If I come across any that are not completely made in the U.S., I will display the medication names, the company, the place of manufacture along with the location where the medicine is produced.

DOES THIS APPLY IN CANADA AS WELL?

I think our drugs and ingredients should come from the USA

I for one, am frustrated that my generic drug medications come from Asia & India where manufacturing standards are not strictly adhered to. I had had problems w meds manufactured in India ( with one handed over to me by my pharmacy (CVS) ) that was on the fda drug recall list – “for bad manufacturing practices!” This is scary! Not only do we have to worry about all the various side effects of prescription medication, now we have to worry if the manufacturing process in third world countries is problematic & safety standards are being violated!!

Four or 5 years ago I took a pharmacy continuing education course on the subject of foreign-made drugs. It stated that MOST of our drugs are manufactured in either China or India. The FDA has some jurisdiction over the matter. The article said that on average, a manufacturer in China is inspected every 13 to 30 YEARS by the FDA. (Not a typo. Every 13 to 30 years.) The inspections can’t be unannounced. Most or all of the inspectors don’t speak Chinese. Guess who furnishes the translators?

Anyone who has followed the news knows that the Chinese don’t even safeguard their own people as they should–there has been melamine in their baby food and rabies vaccines that aren’t efficacious. A few months after I took that CE course, I saw in the Houston Chronicle that Congress was looking into the matter. As dysfunctional as our Congress has been lately, that does little to reassure me. Follow the money. Drug companies are making big profits. One way they do that is find cheap, cheap sources. We have the best elected officials that money can buy. Worried yet? You should be.

CHINA ? Who knew? I thought we paid more for our medications so we would be protected ! When others were getting meds from Mexico and Canada it was my understanding they were taking chances not purchasing U.S. manufactured medications. It makes me angry to know anything from China may be in something I am unknowingly taking. Can you imagine being a victim of Chinese drywall then Chinese medications ? Disgusting, disgusting, disgusting !!!

There should be a law in the U.S.A. mandating that the country of origin be on all med labels sold in the USA.

Problem is, there probably aren’t any meds that USA is the country of origin. If there are meds that the USA is the country of origin, please let us know! I would be willing to pay more for them.

I realize they could still be contaminated if made in the USA, but we would have a better chance of less contamination than those coming from a foreign country. Hopefully the FDA would be held to a higher standard for drugs made in America.

I agree. Also, Consumers Reports (Consumers Union) should be plugged into this. They do a great job of digging and exposing items like this!

Tom,

We are big fans of Consumer Reports (CR)…but when it comes to generic drugs made abroad they have adopted the FDA’s perspective, ie, everything is fine and dandy. We have discussed this with execs at CR for many years and this is one area that they refuse to hear anything other than generic drugs are identical to brand name drugs and save you lots of money.

Thanks for asking-I’m not comfortable with
the current degree of murkiness regarding
the source/origin of medications. Yes, it
needs to be obvious on the label as to
where the product(s) came from. Why
is the FDA so silent on this?

Can you get this resolved?

Very interesting about CR lack of interest in problems related to generic drugs When in doubt, always follow the money trail.

My doc badgered me for years to take statins even though my blood tests were very good. I finally succumbed and got my first bottle. When I got home i started looking to see who made it and where it was made. The bottle said it was “distributed” by a Florida company. I looked up the name of the company and it had a facility in Florida as well as other places around the world. After spending much time I determined that couldn’t be sure where they were made and I could never know for sure where the ingredients came from. This is a trick when you see a product that proudly boasts it is “Made in USA”. A closer look usually states “includes foreign and domestic components”. It doesn’t really matter if a product is made in America if the ingredients are from China or somewhere else. In the end, I never took the pills. They sit in my cupboard.

I would be willing to pay a little more for my prescriptions if made in the U.S.A. The Valsartan I have been taking was made by Solco which is in China and it was recalled. My mail in pharmacy sent me an envelope with address label so I could return the bottle I had just received but not opened. In turn they sent me Valsartan that was not on the recall list, but it was made in India. It says so right on the label. Now there is a shortage of this drug, my doctors office changed my medication to Telmisartan which I cannot take due to having diuretic properties in it. Shame on who ever approved pharmaceuticals being manufactured in other countries, there is no way that the FDA can over see the proper handling of these drugs in various foreign countries and have all be well. I don’t trust any of these drugs! Can any one recommend a U.S. pharmacy where I can purchase trust worthy prescriptions?

Nix on foreign medicines! I fail to see how the FDA can stand behind a product that is manufactured in a country whose standards don’t match up to this country’s. Disgraceful! Absolutely, a patient has the right to know where his/her medicines come from. Scary!

As a pharmacist of more than 40 years, it’s very difficult now to determine where the true sources of active and inactive ingredients originate. I think it’s unfair to the pharmacist to say that she was not forthcoming as to the source. So many pharmacists are extremely busy that they can’t always resource their replies, especially in a retail setting.

It needs to be more transparent the source of all ingredients. The FDA, although we understand remains chronically understaffed, needs more agents to address this acute problem. Also there are other agencies that regulate pharmacies and pharmacists but particularly the state boards. They also have joint responsibilities and these matters.

Realistically, pharmaceutical manufacturers should be labeling their products clearly with countries of origin. It’s rather ironic that we label fruit products with country of origin.

I absolutely agree that it is unfair to the pharmacist to say that she was not forthcoming as to the source of the medication, and I feel the title of the article is intentionally inflammatory. I have been a pharmacist for 30 years and have yet to meet a colleague who would intentionally mislead a patient about the source of their medication. Pharmacists are consistently rated among the most trusted and ethical profession for good reason. We are patient advocates through and through.
Also noted that a few comments later regarding the question if all Valsartan products have been ‘pulled from shelves” (not recalled), the response is “not true.” In some pharmacies it IS true that all the sources of Valsartan have been pulled from the shelves as a precaution even though they are not listed on the recall, because the nature of the recall is so fluid and the overwhelming reaction of most of us is to protect our patients above all else.
I’ve been a long time People’s Pharmacy promoter because I felt the primary focus was to educate consumers, but this feels a lot like finger pointing. Let’s get back to empowering each other to work together as a healthcare team in order to obtain the safest, optimal outcomes.

Totally agree. Pharmacist could have been more cautious, (just because something hasn’t been recalled YET does not mean that it won’t be in the near future) but I have personally made calls to these manufacturers & the answers received were “murky”. If manufacturing were brought back to the USA we’d have a higher level of protection. I have also made comment on this & the public seems not to know that most of the rules & labeling requirements as well as pedigree & chain of custody with regards to refrigerated items comes from state Boards of Pharmacy.

My pharmacist told me that at this point all brands of Valsartan has been pulled from shelves, no matter the maker. Is this correct?

Not correct…The FDA has provided lists of drugs that have and have not been recalled. Here is a link:

https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm

After developing Lichen Planus from diuretics, a severe allergic reaction from Losartan and Diovan, I think that ALL medications should be made and manufactured in the USA. I have
a hard time tolerating most drugs due to allergies and to have the added uncertainty of these
medications is beyond what I expect from the medical world. I hope this system will change.

I absolutely believe that country of components and manufacturer should be prominently displayed on the label of the bottle. Food is another issue where the country of origin should be on the packaging. The fact that these labels are absent should scare the hell out of all of us.

I stopped using chain drugstores because everything they fill is from India or China, two countries with so many warning letters and unethical practices over the past five years since our FDA finally started checking the manufacturing and lab testing facilities there. These countries do not have the same standards as the USA.

It is difficult for me to fill some prescriptions and I have, at times, chosen to go without. Finding drugs made in the USA is not easy anymore. I suspect many people who do not get well after taking a course of an antibiotic or another drug, when switched to a different brand, get well because the second or third drug (many times the brand or another more expensive medication) is properly manufactured for safety, efficacy, and sterility unlike the first generic they took.

Those cheap drugs are cheap for a reason….buyer beware and start demanding more information about medications you are going to put into your body.

I want my medicine to be made in USA or Canada only

I think the country where drugs are made should be prominently listed, as you mentioned. I would be willing to pay a little more for medicine made in USA. Why is this info so hard to find? Does FDA check drugs made in other countries for content and quality? Sometimes I wonder what we’re doing to ourselves unknowingly.

My prescription provider Express Scripts has contacted me via mail. They are requesting that we “do not send in refills or renewals for valsartan, but obtain an alternative therapy from my prescriber and send it to us”.

I have taken many different types of drugs such as PPI’s and BP meds only to wind up in the hospital with racing heart rates, over the edge BP and allergic reactions. My sister-in-law had the same reactions to other meds including panic attacks. One thing all of these drugs had in common although they were for very different diseases was that they were ALL manufactured in India.

If we are allergic or have reactions to compounds from other countries, as I am sure a great number of people are, we should know where the drugs are manufactured. We have a right to know. I am tired of hospital emergency room trips due to drug reactions. Now I refuse to take any drugs not manufactured in the US. Why play games with our lives? We deserve the right to chose our drug manufacture location.

Our pharmaceutical companies need to stop getting ingredients out of the United States now I am fearful of even taking my prescribed medications

They should put it on every pill bottle or any thing else that comes from Canada or india .

I was taken off Valsartan, and am now on Losartan, but don’t know where it’s made. I have never seen anything on a bottle showing that information. I am now worried about hydrochlorothiazide, and also found out it could have a connection to gout, which I have had twice in the past year. Medication can be worrisome, especially on older adults.

It is truly a sad state of affairs that pharma companies value bottom line profits over doing the right thing for the patient who is also the customer. Why kill the golden goose?

Many of us had rather pay extra for US made products than risk the danger of contaminated products from India/China/wherever. Pharma should step up….stay in the US, protect the patient/customer and provide jobs for Americans.
Enough said.

If the ingredients are made in China or India, for example, it becomes moot regarding fillers, a company’s presence in the U.S., etc. Even the brand drugs likely source ingredients from countries that the FDA scarcely has a presence in. On top of that, try to picture a trade war with China where they refuse to provide essential ingredients to our domestic makers. I see one more worrisome and governmentally neglected area ripe for chaos.

I would like to have all my medicines made in the U.S. because I feel somewhat protected by the FDA. However, the prices are outrageous already. Many people cannot afford the medicine that they prescribed. What are we to do? How do we get quality and safety and affordable drugs? My husband was on valsartan and it has since been changed to an alternative. It makes me concerned about all of our medications.

My Cardiologist switched my blood pressure med from recalled Valsartan to Lorvarstan are their any problems with this medication??…..Very grateful for People Pharmacy website that’s how I initially found out about the recall,thank you so much

My 3 month supply of Losarta ( Hyzaar)in just came in a large white bottle. I immediately Ckd where it was manufactured. You guessed it! Madadoob Nagar, India. Should I take it?

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