good supplement, heart problems

Do you swallow any pills in the morning? We would be surprised to learn that you don’t. Most Americans swallow a handful without even thinking. Let’s start with vitamins. Millions of people take B vitamins along with C and D. Then there are dietary supplements like turmeric (curcumin), calcium, magnesium, glucosamine, CoQ10 and probiotics. Many people take pain relievers (NSAIDs) like ibuprofen or naproxen along with acid-suppressing PPIs, blood pressure pills, diabetes drugs and cholesterol-lowering medicines. Do you have a clue where your pills are made?

Once Upon A Time:

There was a time when most prescription and over-the-counter drugs were made in the USA. That included both brand name and generic medications. The FDA made a concerted effort to inspect manufacturing facilities on a regular basis.

These visits were not announced in advance. That always made sense to us. No one would want a drug manufacturing company to know the inspectors were coming. That way FDA officials could see what was really going on in the facility. You would not want the local health department to notify restaurants in advance that they were planning to inspect the kitchens.

Where Your Pills Are Made Today:

Over the last two decades, the pharmaceutical industry has changed dramatically. Manufacturing of many medications has shifted overseas because it is cheaper to make medicines in China, India, Thailand, Slovakia or Brazil.

The Story of Aspirin:

A decade ago Gardiner Harris wrote a compelling article for the New York Times Magazine titled “The Safety Gap” (Oct. 31, 2008). His first paragraph tells the story of aspirin:

In the belly of an industrial district south of Lyon, France, just past a sulfurous oil refinery and a synthetic vanilla plant, sits a run-down, eight-story factory that makes aspirin, the first pharmaceutical blockbuster. The Lyon factory is the last of its kind. No other major facility in Europe or the United States makes generic aspirin anymore. The market has been taken over by low-cost Chinese producers. Even Bayer, the German company that created aspirin in the 1890s and has fought for more than a century to distinguish its product as the most trustworthy one, now has backup supplies from China.”

Mr. Harris went on to point out in 2008 that “China now produces about two-thirds of all aspirin and is poised to become the world’s sole global supplier in the not-too-distant future.”

How would you know where your aspirin is made? Certainly not by looking on the label! What about acetaminophen, ibuprofen or naproxen. Do you have a clue where your vitamin D3 comes from or your vitamin C? Chances are you don’t. There is nothing on over-the-counter drugs or dietary supplements to tell you where your pills are made.

Where Was the FDA?

The FDA was slow to respond to the outsourcing of pharmaceuticals. It took years for the agency to figure out how it might assess foreign-based facilities. Countries like China and India require notice far in advance before an inspection can take place.

We’ve never understood why the FDA tolerates such limitations. If a country wants to export its pharmaceuticals to the USA, shouldn’t it have to play by the same rules as American-based manufacturers?

FDA Warning Letters: Form 483

Even with advanced notice, many foreign manufacturers have received warning letters from the FDA. The Food and Drug Administration labels such warnings a Form 483. What this letter typically means is that the company has violated an FDA rule. It might have to do with manufacturing or misinformation.

Companies that have received warnining letters from the FDA include Wockhardt, Ranbaxy, Dr. Reddy’s Laboratories, Aurobindo, Sun Pharmaceutical Industries and Fosun Pharma. In some cases the agency detected deviations from good manufacturing processes and kept some of their drug products from being sold in the US.

The Valsartan Debacle:

This summer, valsartan blood pressure pills were subject to a world-wide recall. The problem pharmaceuticals contained an active ingredient made by Zhejiang Huahai Pharmaceutical Company in Linhai, China. The company had changed its manufacturing process and as a consequence the medicine was contaminated with a probable carcinogen, NDMA. This problem had gone undetected for years.

More recently, a US subsidiary of an Indian company, Accord Healthcare, mislabeled bottles of blood pressure medication. The label said hydrochlorothiazide 12.5 mg. The pills actually contained spironolactone 25 mg. For some patients, this mistake could have been a life-threatening error. These two drugs have very different effects on the mineral potassium. Hydrochlorothiazide depletes the body of potassium, while spironolactone can raise potassium levels.

Readers Want to Know Where Your Pills Are Made:

One reader wrote:

“HCTZ was prescribed to lower my idiopathic high potassium level. I am beyond grateful for your column addressing the recall of Accord’s generic formula. I’m concerned that this medicine could be having the opposite effect of its intended one.”

Many people would appreciate knowing where their pills come from. One woman tried to do her homework:

“I take losartan. With the recall of valsartan, I wanted to see where my own drugs were manufactured. I happen to have two generics in my cabinet, one being a new refill.

“I called CVS. The pharmacist could only find the location of one of the drugs. It 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, but she gave me the phone number for the drug company. I called and they would not tell me where the drugs where manufactured. They said it was basically their secret.

“The drug companies do not have to make the country of origin public knowledge. I am appalled by this. It needs to change!”

Another reader expressed an opinion that many share:

“All drugs sold in the US should be labeled as to country of origin for all ingredients. We need Congress to pass a LAW to that effect ASAP!”

The People’s Pharmacy Perspective:

We believe that all pharmaceuticals and dietary supplements should have country of origin information on the label in print that anyone can read. We also recognize that this is complicated. The active pharmaceutical ingredient (API) in any pill is the most important component. But there are other ingredients as well. They include binders, fillers, coloring agents, etc. These are referred to as excipients or inactive ingredients.

A blood pressure API like lisinopril might be made in China. But the other inactive ingredients might come from Slovakia or Pakistan. The final pill could be manufactured in India. What should go on the label? We think there are two essential factors: Where did the active pharmaceutical ingredient (API) come from and where was the pill formulated? At most, that would be two countries. That’s not so difficult.

Chain pharmacies might decide that their customers would like to purchase vitamins, over-the-counter medications and prescription drugs made in a country where FDA inspections are unannounced.

What do you think? Share your own perspective on where your pills made. Do you think country of origin information should be included on vitamins, dietary supplements and pharmaceuticals?

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  1. Candice
    CT
    Reply

    I think every thing should labled, I think the FDA should be monitoring it. I know there there is practically no monitoring of the overseas facilities. If these products are being made cheaply in China and India, why are they costing us an arm and a leg?

  2. Virginia
    Georgia
    Reply

    Doesn’t really matter if you know or not–there are almost no other options, unless you are independently wealthy ! The FDA is really not up to the task of protecting consumers and are at the mercy of Big Pharma, even though it is supposed to be unbiased. We are really behind Europe, Canada, and other countries on this subject. A major quick shift in legislation is required.

  3. Annette V.
    Plano, Texas
    Reply

    This is “Elementary Common Sense” in my opinion. The USA FDA should monitor ALL imported drugs, including routine inspections of the manufacturing facility. Better yet, manufacture them in the USA!! 🇺🇸

  4. Paul
    WA
    Reply

    Appears to me that our elected officials are much more concerned with keeping the flow of money to fund their re-electtion campaigns than with the safety of what is consumed by their constituants. So let’s fix that. Elect all new individuals. But who is going to fund the election of new office holders? OOPS!

    Might it be time for taxpayer funding of election campaigns? That way there could be limits set on the maximum candidates could spend. The pols have had a long time in which to create the cozy process we now have whereby office holders and/or candidates are, in effect, payed in advance for their votes in the future. Anyone see any problems with this?

    Wish I knew how to cause this change in how we elect our pols.

    • Brenda
      Colorado
      Reply

      Paul, I think you already have the answer to this. Vote all these corrupt politicians out, and elect ones that pledge not to take any SUPER PAC money or bribes from special interest groups. We need a complete overhall of Congress right now.

  5. Larry L.
    Wisconsin
    Reply

    Country of origin should be required by law.

    The U.S. DHSS should be given the responsibility and budget to enforce such a law.

    Civil and criminal penalties for failure to disclose and to disclose accurately should be imposed.

  6. Terry
    Matthews NC
    Reply

    So, it is illegal to purchase drugs from other countries but it’s perfectly ok for these countries to secretly send the same drugs to our pharmacies which, in turn, sell them to us for more money!!

  7. Heide
    Reply

    Absolutely, I want the countries of origin for my meds, BUT still how would we know if the meds are what they are supposed to be with no FDA looking over their shoulders?

  8. Linda
    Ohio
    Reply

    I think country of origin information should be included on vitamins, dietary supplements and pharmaceuticals. Thanks for advancing this idea and for making room for others’ responses. Maybe we can help get something going.

  9. Daphne
    England
    Reply

    Daffodil from England.
    This is quite frightening.
    How do we find out where they are made if we are in the UK?

  10. Dee H.
    California
    Reply

    For some time I had been taking Celebrex and then I became a Kaiser member. When a refill was required it took me several refills to notice that the Celebrex wasn’t working as well. I noticed on the bottle the manufacturer was either in China or India. Having looked up the original manufacturer of Celebrex, I requested that their subsidiary be the supplier of further refills. Kaiser didn ‘t like it, but my doctor approved when I mentioned that the Celebrex made by a foreign company was no where near accomplishing pain relief for me.
    Now I LOOK at the manufacturer of any prescription meds prescribed to me, realizing Kaiser is a massive organization and would like to buy less expensive drugs – I am amazed that they do not wish to give their patients the best medicines to cure/help them!
    Everyone needs to take care and be watchful!

  11. Sally
    Jacksonville,OR
    Reply

    I believe most Vit C is made in China

  12. renee
    beverly hills, ca
    Reply

    we all need to flood the FDA with comments about drugs made in other countries, especially China !!!!!..start writing emails!!!!…even some of the ingredients are made in China and sent here and mixed here…..companies in the USA should not mix ingredients from other countries……that will kill people or make them sick……FDA could do better…..^.^

  13. Orangehues
    NY state
    Reply

    I had been taking Valsartan for about 2 or 3 years when I read about the recall in People’s Pharmacy newsletter. I asked my local pharmacy when they were notified and it was just the day before I read about it!! It was a big problem; they were swamped with the work.
    I had always assumed my drugs were made in the US and the FDA was keeping strict tabs on the quality. If there’s one product where quality control is the most important I would have to say it is in the manufacture of drugs which have the power to kill. We must insist to Congress that all drugs be manufactured in the US where we at least can hold the FDA to their responsibility to protect us. Write or call your Congressperson.

  14. elaine
    Illinois
    Reply

    Maybe Congress could create manufacturers for the 20 leading generic drugs purchased by Medicare. then they could control everything from the beginning and ensure that the medication is made to FDA standards.

  15. Linda
    PA
    Reply

    This is what I do not understand about pharmacies saying that they do not have any information to give customers in regards to their drugs. I recently had a 90 day prescription of valsartan filled by CVS. It came in a large plastic bottle not unlike the bottles I see on the shelves behind the pharmacist. On that bottle was written the lot number, the NDC number, the manufacturer (in this case, Jubilant Cadista, made in India). I was able to go on the FDA recall list and check these numbers. I also went on the Cadista site and noticed that they had 2 lots that were being recalled. Luckily, I did not have any of them, but my point is that is was not that hard, and also, these pharmacies DO have this info. My sister ordered a smaller version of the valsartan and that was in one of those amber plastic bottles with NO info on it. I think the public has a case for at least demanding thier drug stores to supply this info when they clearly have it…. right on their shelves in most cases.

  16. Jerry
    Illinois
    Reply

    Check out this website: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm
    On your Rx label is the company name that manufactures your prescription. If you go to the above website you can see if that company is registered with the FDA. One of my previous prescriptions was from a company that was unregistered.

  17. Marianne
    Pittsburgh
    Reply

    This is an outrageous situation!! And what happens if countries providing our meds are not on friendly terms with us? China has a history of trouble providing safe products for it’s own people, vis a vis the baby formula debacle years ago that caused the death of so many infants. I will be contacting my US senator and reps immediately!

  18. deejean
    Wisconsin
    Reply

    After reading this article I emailed my two Senators and my congressman. It is really appalling that this has happened. The efficacy of our Rx drugs is life and death for many of us and the fact that these substances can be harmful is really scary, especially when we think of children taking their antibiotics for infections that has just come from a filthy dirty factory in China or India or wherever. If you haven’t written you federal congressman, please do it now.

  19. Maryellen
    Richmond, VA
    Reply

    Of course we have the right to know where our prescription & OTC’s come from – both the ingredients & place of manufacture. They should be made in U.S. where they are within the oversight of the FDA & if not they should meet the same criteria.

  20. Gary
    NC
    Reply

    A US based company is having product made off shore shipped to the US for distribution. The FDA should inspect product for proper ingedrents. Hold the US company accountable. Heavy fines will get their attention.

  21. Mark
    NC
    Reply

    I take vitamins and attempted to find out the source buy most companies refused to tell me. Only NatureMade clearly states it on their website:

    Where are your products manufactured?
    Answer: All Nature Made products are manufactured to meet our high quality standards. Most all of our products are manufactured at our own facilities in Southern California. For the few products that are made by other companies, we work with a few, select, highly qualified contract manufacturers that manufacture to our high standards. Most of these contract manufacturers are located in the United States, but a few are located overseas. None are located in China.

    Read more at http://www.naturemade.com/faqs/general-faqs#vlydaLzatL9QQclL.99

  22. TY
    Georgia
    Reply

    Alarming! I have a nephew who takes medications for mental health and different binders
    made a difference to him.

  23. Howard
    Illinois
    Reply

    We have an absolute right to know where our pharmaceuticals are manufactured! Country of origin labels are required on clothing, food products, household products, etc. How come not on drugs we consumer? I agree with a previous comment that drugs and supplements SHOULD BE manufactured in the USA. Overseas manufacturers cannot be trusted. Unannounced FDA inspections of plants are the only way to insure we get safe products.

  24. Faye C
    fort Walton Beach
    Reply

    of coarse we should know where our meds are made and why are they made in America I know there are plenty of people to work in those factories . Why is the FDA putting all of our lives in danger. Faye Coronado

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