Here we go again: another generic metoprolol recall from an Indian drug company. The FDA announced problems with Dr. Reddy’s metoprolol succinate 25 mg extended release tablets and the company is in the process of recalling 1,356,000 pills.

What is going on with this heart medicine?

Toprol-XL (metoprolol) is a beta blocker in the same family as atenolol and propranolol. Tens of millions of people swallow beta blockers every day to control heart rate, reduce the risk of a second heart attack, prevent migraines and ease the pain of angina. These medications may also lower blood pressure.

The original brand name medicine was developed under the name Lopressor and was an immediate release product. That means it had to be taken up to four times daily. That was inconvenient for many people. The extended-release formulation, Toprol-XL, was approved in 1992 and was given once daily, making it far more patient friendly.

We first suspected that there might be problems with generic extended release metoprolol succinate in 2007. Readers of our newspaper column and visitors to our website began reporting therapeutic failures when they were switched from Toprol-XL to metoprolol succinate. Here are just a few of their reports:

“After taking Toprol XL with good results for three years to control cardiac arrhythmias, I was given a generic substitute three weeks ago when I switched pharmacies.

“After taking the daily dosage for five days, I began having more and more arrhythmias to the point of having to be admitted to the hospital. There were no other differences in my daily life.

“After discharge, I returned to the unused brand name drug (Toprol XL) and have had no further problems.” Nancy, March 20, 2007


“I have been taking brand name Toprol XL for quite some time without any problems. Last week, I ran out and my doctor phoned in the refill for a generic prescription. I received metoprolol ER.

“I took it for 7 days. This is absolutely NOT the same. I have a blood pressure cuff that records my last 100 readings. During about the first 12 hours after taking it, my blood pressure was way too low. During about the last 12 hours, my blood pressure was much higher than it ever was. I am on my way now to pick up a new prescription for the brand name, at an additional cost to me, of course.” Debbie, July 5, 2007


 

On October 21, 2007, we wrote to alert the FDA and its Office of Generic Drugs about the problems patients were reporting with this medication. We were told, in essence, “We’ll get back to you.” We heard nothing more.

Over the last several years there have been a number of recalls of generic metoprolol. In 2008 the FDA warned Sandoz that its formulation of metoprolol succinate had not been properly validated. There were dissolution problems. In other words, it didn’t dissolve properly in a test solution. Sandoz recalled its generic formulation of metoprolol that year.

In 2009, Ethex, a subsidiary of KV Pharmaceutical, also got into trouble with its extended-release metoprolol. The company eventually pleaded guilty to felonies of failing to notify the FDA about manufacturing problems with a variety of medications.

Fast forward to 2014. In May, a large Indian drug manufacturer called Wockhardt had to recall 109,744 bottles of its metoprolol succinate. This company had two of its manufacturing plants shunned by FDA in 2013. Violations in manufacturing meant that products from these facilities could not be exported to the U.S. One of the plants made metoprolol succinate. Until these discoveries, Wockhardt provided one fourth of the metoprolol swallowed by Americans.

Now we are told that another Indian drug company, Dr. Reddy’s Laboratories, also has problems with its metoprolol succinate. It is in the process of recalling 13,560 bottles from the U.S. market. This involves 25 mg tablets from lots C206578 and C207415 (NDC 55111-466-01). In both the Wockhardt and Dr. Reddy’s recall of metoprolol the problem was dissolution. That is, the formulations were not releasing the active ingredient according to FDA specifications.

But here is the rub. Although the FDA considers the Dr. Reddy’s recall important (Class II, which means “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences”) it is doing little to alert patients. Pharmacies are supposed to stop dispensing such products and return them to the company. But patients who have Dr. Reddy’s metoprolol succinate 25 mg pills, even if they are in the recalled lots, are supposed to keep taking them. Huh? Does that make any sense?

Even if you wanted to check on your bottle of pills to see if it was included in the recall, the chances are very good that you would not find a lot number. That’s because most state pharmacy rules do not require lot numbers on repackaged pill bottles. Why is it that there are lot numbers on all over-the-counter medications, soup cans and cereal boxes but rarely on a prescription bottle of generic pills? Does that make any sense to you?

Here are some more recent complaints about metoprolol from visitors to our website:

“My metoprolol was usually a small, white, tapered pill. My prescription was refilled with one that was white and aspirin-shaped. After taking only a couple, I experienced an irregular heartbeat.

“I called the pharmacist and she exchanged the round pills. The problem stopped. When I told my previous doctor what had happened, she said, ‘That couldn’t happen.’ I said, ‘The pharmacist said it could.’

“Later my drugstore ran out of the small white tapered pill. I was sent to another drug store to get it refilled. I told the pharmacist what had happened and he said, ‘Of course that happened; the round pill is not time release.'”  E.T., May 16, 2014


“After having a bad reaction to a generic metoprolol in 2007, I began using the AstraZeneca original (Toprol-XL) and then switched to the PAR extended release generic, which is the one authorized by AstraZeneca. It’s more expensive than other generics but I’ve always done well with it (50mg/day), so for me it’s well worth the money. To my knowledge there’s never been an issue with this generic, but I look forward to PP corroborating that.” Gerald, May 16, 2014


“I too had cardiac problems after being on metoprolol for a few years. My GP refused to believe I had problems from the medication. Eventually I was hospitalized. The cardiologist stated that if I had not come to the hospital via 911, I would not have survived.” Marjorie, RN, BA, May 26, 2014


Were this the only generic drug recall in recent years we would not be terribly worried. Unfortunately, dozens of different generic drugs have been recalled. We were instrumental in identifying the problems with generic versions of the antidepressant Wellbutrin XL 300. A generic product called Budeprion XL 300 was eventually withdrawn after we bugged the FDA for years because of reports of generic drug failures by visitors to this website. A different bupropion XL 300 was also withdrawn with little fanfare from the FDA.

To learn more about this tale of woe and intrigue, check out of book, Top Screwups Doctors Make and How to Avoid Them. It provides our “Top 10 Tips for Taking Generic Drugs,” since insurance companies virtually force most Americans to buy generics. We’re not against generic drugs, but we wish the FDA would do a better job both approving bioequivalency and monitoring foreign manufacturers. In the meantime, people will have to take steps to protect themselves. We hope our tips for using generic drugs safely will help.

Share you own generic drug story, positive or negative, below.

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  1. SalW
    Reply

    I get weekly emails from the FDA which include all recalls, but there has not been one mention of this recall. My husband and I recently saw his cardiologist, and he was very interested in all of this information.
    I have to assume there is a problem in getting the message out to the health professionals that need it and also to unsuspecting patients.
    Since generic companies are not required to put lot numbers on their drugs, there is no way to know what to pull from the shelves. I doubt there is any information a pharmacy can get from the FDA if they don’t really believe it is a problem. So, these pills still remain on the shelves because no one thinks there really is a serious problem.
    For our protection, we are staying away from the four pharmaceutical companies in India which have had problems. If no one will protect us, we will do it ourselves.

  2. Bunny
    Reply

    I have been on Metoprolol succ. ER for a longtime. Recently I came close to running out of my prescription, called my internist to just order what I needed for a short time until my mail order came in. I have always had AstraZeneca and the fill in was from Watson. I had to stop the Watson brand D/T it made me extremely dizzy and could not function. So all generics are not created equal. I did call Watson and reported the issue, my local pharmacy told me to stop taking it.

  3. P Braddock
    Reply

    I was recently shifted to Metoprolol succinate from another beta blocker and was supplied by my pharmacy with Dr. Reddy’s 50mg round tablet scored, making it possible to reduce one dose to two/25mg doses. Why would only the 25mg version be recalled? Is my supply effective and is it safe?

  4. sharon
    Reply

    I’ve been taking Metoprolol Succ ER for years and it does a good job on my a-fib. However, I’m wondering if it is causing the severe weakness I experience…not tiredness…but weakness. Can anyone help? -sharon

  5. DONNA
    Reply

    I have been taking metoprolol for a year, and have been noticing a very tired feeling and a much lower blood pressure the last few months… plus the fact the shape of the pill changed recently… I too, will be checking with my mail order delivery service and questioning my doctor about this, and going back to toprol if I can afford it. Thank you for the info……

  6. CarolF
    Reply

    Kathy, what did you finally settle on instead of the Levoxyl? I haven’t noticed any side effect from the generic but my TSH bounces around and I have had some hair loss. I am known for my thick hair so nobody notices it but me. I never had any symptoms of low thyroid. It was just picked up in a blood test years ago. I would like to go back to Levoxyl but now is it more expensive.

  7. RB
    Reply

    For women taking Zetia, there seems to be better effectiveness if we also take good quality fish oil. Like ND who commented this morning, I don’t tolerate statins (nor does my sister nor our 3 late brothers). Fish oil helps, as well as providing some relief of arthritic joints.

  8. ND
    Reply

    I have been on metoprolol succ ER 25 mg for a few years, since I had a minor heart attack (never really sure why I’m on it). Mine are from PAR. I am not aware of any issues for me. It does worry me though that affordable meds may be dangerous. Paying for Plavix was a real problem, I hope there are not problems with the generic. Blood “thinners” have potential for very real danger. Now I have to take Zetia, because each of the three statin drugs I tried caused muscle pain, Zetia is quite expensive. Wish I didn’t need meds.

  9. Teresa
    Reply

    Why are our drugs being made in foreign countries? We need jobs in this country. I know it’s all about money savings, but how much are you saving if people end up in the hospital, or worse case, dead?
    I too recently had a problem with generic Ziac. Food Lion pharmacy switched generic drug companies in January. It took me a couple of months to realize the generic they switched me to (which I’m sure was a cost savings to Food Lion!) was not working.
    I thought I was going to end up in the ER! I had some of the original generic prescription in my purse and started taking it and my symptoms went away within a couple of days. I went to Food Lion Pharmacy and they switched me back to the original generic. Let’s bring our manufacturing of drugs home.

  10. NBM
    Reply

    If the response to this topic, on this site, is any indication of the problems with the generic versions of medicines in this country, we are in big trouble!! Something needs to be done, at the national level, to get the FDA’s attention. I would suggest a “Congressional Investigation”, but with the “do nothing Congress” we now have in office, that would be a futile effort. Has PP considered sending the FDA copies of all these complaints?

  11. LND
    Reply

    This same thing happened to me with the generic Toprol XL. I was hospitalized twice over irregular heartbeat. This last time I had to be shocked back into rhythm. I had an ablation the first time. They need to do something about this. I am on Sotalol now. Still not working so well.

  12. Kathy
    Reply

    I went through a terrible transition period when Levoxil for my thryroid was taken off the market because it had a funny smell. I had been on the same dose for 30 years. I had heart problems, my blood levels when haywire and after trying three or four other generics and Synthroid. I am balanced again. I am off the heart medication and it has been hard to get the doctor to take the diagnosis of heart problems off my chart, he still wants me on heart medications. KC

  13. Henrietta
    Reply

    I worry, too. I am the only person at my pharmacy now getting the brand name Avapro. All the other customers are getting the generic version. Wondering what to do if it is no longer manufactured. The brand name is extremely more expensive, but, to me, worth it!

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