The People's Perspective on Medicine

Pharmacist Wouldn’t Take Back Recalled Valsartan BP Med

Who's responsibility is it to take back recalled valsartan? Should patients get a refund for a contaminated drug? What happens when a pharmacist refuses to honor a recall?

On July 5, 2018 the European Medicines Agency announced a recall of a generic blood pressure medicine called valsartan (Diovan). The active ingredient in some generic formulations was apparently contaminated with a carcinogen called NDMA. Read our first health alert here.  On July 17, 2018 the FDA announced a voluntary recall and shared this: “The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China.” The companies were Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutials. But some pharmacists were reluctant to take back recalled valsartan as this reader points out.

Recalled Valsartan: Who’s Responsibility?

Q. What can you tell me about the recalled valsartan? I have been taking the Solco product for some time. When I spoke with the pharmacist yesterday I was brushed off as if there was no problem. He acted as if the recall wasn’t a big deal and that they were doing nothing about it.

Should we customers call the FDA for advice? I am concerned about continuing to take the 90-day prescription that was filled a few days ago.

A. Valsartan (Diovan) is a widely prescribed heart and blood pressure medicine. The recall IS a big deal! Some generic valsartan pills were contaminated with (NDMA), a probable carcinogen.

A Chinese company (Zhejiang Huahai) sold contaminated valsartan to a number of generic drug manufacturers around the world. Solco Healthcare U.S. is a subsidiary of Huahai. Other U.S. companies affected include Major Pharmaceuticals and Teva’s Actavis valsartan.

The FDA states that:

“patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.”

The FDA also notes that:

“Zhejiang Huahai has stopped distributing its valsartan API [active pharmaceutical ingredient] and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.”

Your pharmacy should provide you unaffected valsartan at no extra cost. If there are shortages, your doctor could prescribe a similar medication such as irbesartan, losartan, olmesartan or telmisartan.

What We Don’t Know About the Recalled Valsartan:

There are many unanswered questions regarding the recalled valsartan. Here are just a few of our concerns?

When did the contamination first occur?

A report from Reuters suggested that the carcinogen might have occurred as early as 2012.

Did the FDA discover the problem?

As far as we can tell, the FDA followed the European Medicines Agency in recall. Why didn’t our regulators discover the problem sooner?

If people have been swallowing a carcinogen daily for years, who’s responsible?

If someone taking the recalled valsartan gets cancer, is anyone responsible? Will the FDA require the Chinese company to do any epidemiological follow up?

Will we ever know if people have been harmed?

Our guess is probably not. The FDA has been notoriously lax in requiring long-term cancer studies regarding medications.

You can read more of our questions for the FDA at this link.

Our Guide to Blood Pressure Treatment provides information on other options to control hypertension along with a number of non-drug options. Share your own thoughts about the pharmacist’s responsibility for taking back and refunding patients for recalled valsartan.

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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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What you posted:
Read our first health alert here. On July 17, 2018 the FDA announced a voluntary recall and shared this: “The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China.” The companies were Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutials. But some pharmacists were reluctant to take back recalled valsartan as this reader points out.

My thought: If MAJOR or buys ingredients (in this case VALSARTAN) from Zhejiang Huahai, what about other drugs (LOSARTAN, OLMESARTAN among others in the class) – do they have the NDMA contaminant? Is FDA checking for contaminants of any drugs from CHINA? or INDIA? or ISRAEL? Are any generic drugs actually manufactured in the USA anymore???

I, too was taking Valsartan and my NP switched me at my request to Olmesartan (generic Benicar). My pharmacist suggested I keep my bottle of valsartan, as sometimes the drug company will refund the cost to the consumer. I’m not waiting on that one, but am keeping the bottle just in case they might. My issue then became Rx was for 10 Mg, but olmesartan comes in 5 or 20 mg. The pills are sooooo tiny I could not cut in half and my Medicare D will not approve taking two 5 mg, so I have to pay more money!!!

I wish people realized they have options, other than pills. Then, they are not at the mercy of the unscrupulous.

I have friends who were able to get off all BP and cholesterol pills within several months by following the Ornish diet.

Personally, I eat a very healthy (not typical American) diet to eliminate inflammation and decrease autoimmune disease. I’ve done this for nearly 20 years. Food is our real medicine!

Upon reading the Peoples Rx newsletter in this regards, I called my De, and got a call back immediately to come in and deal with it. My Dr. probably only knew about it at the same time Peoples Rx warned us. My Dr. was going to call me if I had not called first. Yay to everyone involved.

I am now taking losartan, which is apparently the original ARB on the market – old and tried and true. Losartan has the same action and side effects panel. Valsartan was felt to be more effective when first prescribed for me, but I have responded well. I am having no side effects and my BP is a bit lower, I may need to back off some – with losartan I have been running 105 over 60 which is a low baseline if I have to work very hard; so I have to be more careful about hydration.

My BP drops a lot if I get deflated from heavy sweating and not enough electrolyte and fluid replacement.

So far so good. I would like to know much more about NDMA.

Before switching to Losartan find out if it was made by Solco as it is in my pharmacy. So, rather than switching and finding out another switch is necessary I am continuing to take my 3 month prescription of Valsartan and hope that by the time I need a refill, Valsartan will be ok again.

The day I got the notice I took my almost new Valsartan HCTZ bottle to my Walgreens. They said their only information said to give people a phone number to Solco. They refilled a prescription for a nonaffected med but would not give credit…had to pay another copay. The Solco rep just took my name and number and said they had no idea how they were going to handle it. Not happy. Still have almost 90 days in a drawer.

I appreciate the information. I have taking Diovan and the Valsartan for 14 yrs. Obviously the insurance company demanded the generic. I use CVS and yes they have been distributing the Solco Pharmacy brand. And yes my lot number was one of the recalled.

I am 53. I had aggressive prostate cancer and had to remove my Prostate last year April 2017. Our insurance companies charge top dollar and then force us to take the cheapest product. Why in the world would we allow our medicines to be produced in the poorest of Quality Control countries. Wake up people! A country that has used lead paint on Mattel toys as recently as 4 years ago, metal in baby formula, carcinogens in dog treats, and high sulphur content in sheet rock and will not stand behind it.

Have no idea what my rights are or if they will ever be defended by the FDA or politicians. Remember these insurance companies, pharmaceuticals, banking industry, defense contractors, energy companies and the like give millions to our politicians. Our pennies will never make a difference.

My pharmacist wouldn’t take back the unopened Chantix after I learned it can cause you to commit suicide (nice one, FDA) so I just ate the $100.

Have AFIB on Varlsatan, HTCZ, Xeralto. Developed Gout, with elevated liver and kidney enzymez. Taken off HTCZ , ER doctor said Varlsatan can cause theses problems and Xeralto TV said should not take if you have elevated liver and kidney enzymes. Allergic to all the HBP meds so what I am to do. Also they say it can cause rapid heart so why am I on these meds?….r

Wal-Green took back what I had and gave me a 10.00 refund.

After my initial contact with the pharmacist and his cavalier attitude regarding the valsartan recall, I decided to phone the customer service department at their headquarters. The representative knew nothing about the recall. After holding approximately 5 minutes, she returned to the call and advised that I should phone the manufacturer (Zolco) to find out what they were willing to do. This pharmacy is a nationwide chain and advertises that they are the most caring and helpful to all of their customers.

They, obviously, do not know what “caring and helpful” mean! Over the years I have spent multiple thousands of dollars with this chain, whether it be over the counter products or prescriptions. No more! I hated to move my business, because there were individuals in the pharmacy and in the retail portion of the store that were very helpful and pleasant. The pharmacist was apparently following headquarters instructions and as a result, has lost a long time customer.

I’ve moved my prescriptions to a grocery store chain that had immediately begun phoning all of their valsartan customers the day the recall was made. My doctor also changed the prescription to losartan. I wish we could list the name of companies that treat their customers this badly so others would know where to spend their money.

I take Losartin and have been taking it for years. I told my Dr that it does not seem to help but she said it does. The recall on valsartin explain it all since the mfg. is Solo.

They should just close the FDA. They are less concerned about the consumer. I’m sure the same filler is in the losartan as in the valsartan.

Charles

My pharmacy changed it’s policy several times. At first they offered a replacement; then they told me to call the supplier. I was told by the supplier that my particular batch was not affected. (Yeah, right!) The pharmacy eventually replaced my Valsartan from another source.

In my opinion, we need to stop doing pharma business with China, period! Also, the FDA needs to loosen it’s grip on the market, making it more free for consumers to purchase their medications elsewhere at better, more competitive prices.

I agree! Please everyone ask the pharmacy before accepting a generic – “WHERE IS IT MADE” and verify by looking at the bottle. Also, write your congressman and the Senate Oversight Committee for the FDA. Tell them the Chinese generic problem is too dangerous and China doesn’t have the consumer protections that other countries have. This cannot be allowed to happen. Also, as much as we hear about the “rare but serious side effects” we should have MANDATORY LABELING that is CLEAR AND CONSPICUOUS as to the country of origin of our generics – simply putting it on the Pharmacist’s supply bottle doesn’t guarantee that the end consumer will know – IT MUST BE ON THE PRESCRIPTION LABEL: COUNTRY OF ORIGIN: CHINA. Also, write your pharmacy and tell them you don’t want Chinese generics. Here’s the address for the Senate oversight committee:

U.S. Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

Wow! My pharmacy replaced my valsartan immediately. No problem.

This all reminds me of the noise my 1961 Pontiac made when I put it in gear. The official response was , “They ALL do that !! .” This translates to, as do FDA comments, Go away boy, you bother me !! ( with apologies to Senator Foghorn Leghorn / Looney tunes and Merry Melodies.

Thanks for the Sweet Memories!

My pharmacy sent me a letter and told me to bring the Rx back and I got a refund immediately. I have also been switched to Losartan. Hoping for the best.

The FDA says “China has stopped distributing the contaminated product”? Is this like Putin says “Russia wasn’t involved in election meddling”? How do they know this? Do they take China’s word for it? Do they test anything? Do they care?

I hope the American people eventually come to understand the apparent ONLY concern of our government, big pharma, big banking, big food etc. etc. is MAKING MONEY, lots of it, with NO thought or concern for harms done or people hurt and maintaining the power they have to continue down this path.

I read your alert 2 weeks ago
Have taken Valsartan for severalyears. Sent portal patientnote to my cardio doctor. He stopped my Valsartan, put me on Losartan. My pharmacist said they didn’t get meds from the mfg. Mentioned. Still, I am staying with losartan. Had gotten the Valsartan from mail order pharmacy. Haven’t checked with them.

My prescriptions always have the manufacturer listed on the label.

In the age of managed care medicine, the pharmacist has very little leeway as to what brands of a drug is stocked. The public wants cheap massed produced medicine and that is what they are getting. Sorry folks, don’t blame the pharmacist, he is just a hired gun. It has gotten to the point that health plans mandate that you use “their” mail order pbm (pharmacy benefit manager) or pay for the product yourself.

I purchase my prescriptions at XXX pharmacy. They refunded the cost, but
I had to call them and ask for it. They didn’t have a substitute to offer, so my doctor prescribed a replacement. When I asked the pharmacy technician if they were going to inform their customers who take the contaminated Valsartan (which XXX distributed) about the recall, the technician replied that they received a recall alert at the pharmacy level so, no, they were not going to alert their Valsartan customers. What does that mean? In the end, it’s best to be our own advocates. However, friends — also on Valsartan — have told me that their pharmacy called to inform them about the recall. Very disappointed in XXX pharmacy.

Every consumer must ask their pharmacy where their meds were sourced. We cannot stand for pharmacies picking the cheapest option. There are virtually no consumer protections in China. I’m stuck with having taken Valsartan for years, and have no recourse. We need to stand together and demand quality.

It’s sad and scary that the active ingredients for most of our drugs and vitamins come from China. As you said, there are no consumer protections in China.

Our pharmacist although reluctant at first provided valsartan from a manufacturer that was not on the list you provided as contaminated. We just insisted it be replaced. Now they have suddenly filled a script for losartan and expect my husband to just begin taking it. I am reluctant to have him switch. He had been taking atenolol for years and developed a couple of side effects so the Dr switched his medication, that started a couple of trips to the ER with sky high BP. Now that he is stable on valsartan HCT we are reluctant to switch again to the losartan. What should we do?

Terry – Most docs are replacing the scripts with losartan. Mine did. I checked before I accepted the meds – I said, “where is this made” and the Pharmacist acted like I was crazy, but I told her, I’m not taking any more meds from China. Ever. This one is made by a company called Lupin. I called them in Baltimore. I asked, where is this made? And they said, “India.” I’m okay with that. But not China. Also, do an internet search on the manufacturer to see how many recalls they have had before. You have to look out for yourself!

Contact your physician for an alternate prescription. I would print out the recall notice and take it to the pharmacist along with your unused Valsartan when you pick up the replacement prescription.
https://www.fda.gov/Safety/Recalls/ucm613504.htm

We actually got a call from Costco telling us to bring it back. They had called the doctor for a replacement, which was waiting for me to pick up. They also refunded the difference of the two prescriptions. All in all great service.

I have been on a Valsartan/Amlodipine combination pill for a number of years. The generic manufacturer listed on the bottle was not one of the listed ones, but my doctor brought up last week in a follow-up appointment, his wish to switch me to Losartan and Amlodipine; taking two separate pills. I am now taking these. I worry for people who did not see the recall or have a proactive physician, given the potential risk.

If the product is contaminated, why should it still be given out? An, yes, who is responsible if people get sick from it or it does not work, and their condition gets worse? Doctors insist that generics are totally safe. Pharmacies say, when I ask them why I am getting a different mfg. company with every refill, that they have to take what they get, and it is safe. But they also say there is a higher or lower difference. They say that yes, people are upset, but they can’t do anything about it. Who will be responsible for people who depend on medicine to stay alive?

THANK YOU PEOPLES PHARMACY FOR BRINGING THIS ALL OUT IN THE OPEN, AND BRINGING OUR ATTENTION TO THE FDA.

If the product is contaminated, why should it still be given to people? Why are pharmacies not told to pharmacies to stop using it, and each person ask their doctor for another SAFE PILL? I would never go back to a contaminated medication. Also, I have been on the same blood pressure pill for 18 years and refuse to change to generic. My body is used to this, and it would be a great concern to me at this late date. I have no side effects.

I am being charged more and more to keep the name brand, and I will continue to pay, but am being told that eventually I will not be able to get anything but generic. Then I will not take any. I am 89 y.o. and do not want to play games with my life and health. I do not trust generics but took them this year for C H disease, and they worked. But by first refill, they changed the mfg, co., and that upset me. I was told that they have to take whatever is sent to them. They claim there is no diffirence, but we all know there is a certain percentage of up or down differences, which could be the difference between breathing or not breathing. . Thank goodness for PEOPLES’ PHARMACY. MAKING US AWARE.
THANKS FOR HELPING PEOPLE BRING THIS STUFF OUT IN THE OPEN.

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