blood pressure measurement, valsartan was made

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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  1. Thelma
    Lakewood Ranch, FL.
    Reply

    I definitely would pay more for drugs made in USA or a country whose manufacturing standards are reliable and similar to ours.

  2. Wendy
    Central Florida
    Reply

    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.

  3. Jackie
    CT
    Reply

    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!

  4. LI
    Reply

    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.

  5. Peter
    Reply

    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!

  6. Donna
    Houston
    Reply

    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.

  7. Dagny
    Philadelphia, PA
    Reply

    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.

  8. Debbie
    Plano, Tx.
    Reply

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

  9. Maryann
    11021
    Reply

    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.

  10. Ellen
    The Villages, Florida
    Reply

    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

  11. Ron
    Florida
    Reply

    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.

  12. Danita
    Florida
    Reply

    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.

  13. Duke
    Reply

    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?

  14. Harry
    Kentucky
    Reply

    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.

  15. Sue
    NJ
    Reply

    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!

What Do You Think?

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