The FDA has just announced that a maker of generic Toprol XL will have to recall 109,744 bottles of metoprolol succinate. That could represent a substantial number of pills.

Wockhardt is a large Indian drug maker and it has supplied roughly one-fourth of the metoprolol swallowed each year in the U.S. Although the FDA previously stated that all the generic metoprolol products it had tested passed initial dissolution testing, a new announcement released on May 14, 2014, reveals that Wockhardt’s metoprolol actually failed this crucial test. The implications are significant regarding FDA’s oversight of metoprolol in particular and generic drugs in general.

Let’s start at the beginning of this tale of woe and intrigue. In 2007 we started receiving messages from visitors to this website that a beta blocker heart and blood pressure medicine called Toprol XL was not working as well as expected in its generic form, metoprolol. As more and more complaints poured in, we contacted the FDA about our concerns.

On October 21, 2007, we informed Gary Buehler (the director of the Office of Generic Drugs) and other FDA executives that there was a problem with the generic formulation of this and certain other important medications.

Gary’s response: “We are investigating all aspects of this issue.”

We heard nothing from the agency that year (or in following years) about its investigation into generic metoprolol. Nevertheless, over the last seven years we have continued to receive complaints from patients who maintained that there were generic metoprolol formulations that were not working the same way the brand name Toprol XL did. Here are just a few examples:

“I had been taking Toprol XL for six years with no problems. When the generic (metoprolol succinate) came out, I was switched to that. All was well for a while but then my blood pressure shot way up. I started having dizziness & numbness on the left side of the face. I also had difficulty breathing and anxiety.

“The pharmacist told me that she has heard a ton of complaints about metoprolol succinate and that it is not the same as Toprol XL. She stated that Toprol XL is a time-release formula & metoprolol succinate is not.

“I had my cardiologist switch me back and I started feeling better right away. By the second day my BP was back to normal.” Roger, December 9, 2007


“Generic metoprolol ER is not the same as Toprol XL. My pharmacy gave me generic metoprolol in December and within two weeks I started having irregular heartbeats.” Stephanie, Feb. 12, 2007


“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


“I was recently taking Toprol XL for a heart rate problem called SVT and was doing fine. Our drug coverage changed and the mail order drug company sent me the generic metoprolol succinate ER tabs.

“About a week after starting the generic drug I was awakened at 5:00 am with a heart rate of 188. We went to emergency and they got it under control. This happened 3 times within a four week period and finally my husband and I told the doctor the only thing we could think of that had changed was the generic drug.

“She immediately wrote a new prescription for brand name Toprol XL. I never had another problem.

“I understand the generic is a immediate release and is in the system for about 6 hours and that the Toprol XL is 24 hour time release. I am 54 years old without a blood pressure problem, but someone elderly could have a real serious BP problem on this generic.” Linda, June 26, 2007


 

We could provide lots more stories about the problems patients have had with generic metoprolol over the last seven years, but by now you get the point.

We have continued to alert the FDA that there was a serious problem with various generic metoprolol products. For people with hypertension, irregular heart rhythms or hypertrophic cardiomyopathy, having a medication that does not work as anticipated could turn into a life-threatening situation. Nearly 40 million prescriptions of metoprolol are dispensed each year in the U.S.

NEW DEVELOPMENTS!

Fast forward to 2014. The FDA recently announced that it would begin testing generic metoprolol succinate…after seven years of our badgering. A recent report from Bloomberg News notes that the agency has received 3,425 adverse incident reports for the drug including “lack of effectiveness,” as well as “troublesome side effects.” In this Bloomberg report the FDA made it clear that in initial tests, generic forms of metoprolol succinate dissolved properly. That seemed to suggest the FDA had tested various products and found they had all passed muster. The way a pill dissolves in a test solution provides some indication how well it will dissolve in a human body.

But that all changed on May 14, 2014. Without a lot of fanfare, the FDA noted that the Indian drug company Wockhardt had a problem with its metoprolol. That prompted the recall of 110,000 bottles of 50 mg metoprolol succinate. Goodness knows how patients and pharmacists will be able to determine which pill bottles need to be returned. Most pharmacies do not put a lot number on the prescription label. Even if you call your pharmacist you may not be able to discover if your metoprolol is part of this recall.

Perhaps even more worrisome is an acknowledgment by FDA spokesperson Sandy Walsh that the FDA is rethinking the criteria it has used for decades for approving generic drugs. We are gratified that the agency is rethinking its procedures, but we worry that there could be hundreds of products on pharmacy shelves that may not be working the way physicians, pharmacists and patients expect.

BOTTOM LINE:

There was a famous phrase uttered aboard the Apollo 13 moon flight on April 14, 1970: “Okay, Houston, we’ve had a problem here.”

For 25 years we were among the country’s most stalwart supporters of generic drugs. But for the last ten years we have been telling the FDA that we have a problem with some generic drugs. We suspect that there are issues with the FDA’s approval process. We also suspect that there are serious problems with manufacturing quality, particularly in countries like India and China where the FDA does not have adequate personnel to carry out inspections. Over the last few years we have heard about problems with Wockhardt, Ranbaxy and Sun Pharmaceutical, to name just a few. Given that the overwhelming majority of our generic drugs now come from abroad, Americans have a right to be indignant.

If you would like to read more about the details of our investigation into the generic drug problem in America and the FDA’s inadequate oversight, we offer our book, Top Screwups Doctors Make and How to Avoid Them. You will discover the details behind the Budeprion XL 300 debacle and learn what steps you can take to avoid generic drug disasters. Here is a direct link to the book.

Share your own generic drug experience (positive or negative) below. We are especially interested in metoprolol stories, but please let us know about any generic drug you have taken.

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  1. J.W.
    Reply

    I’ve been on Metoprolol Succ 50mg for approximately 8 years. Throughout that time I’ve experienced contiuous hair shedding. According to my doc, there is only a 1% chance it’s the Metoprolol. Wondering if anyone else is experiencing the same. The medication has been helpful in other ways.

  2. Sha D.
    Reply

    Was twice in hospital & had to have stress tests, due to new time release pain meds. Now I wonder what I was given.
    Regards

  3. Carole N
    Reply

    Went to pick up my Metoprolol Succ 25mg – today and a notice said the pills may appear different but the content was the same. Since I have severe reactions to some meds, I questioned the change as I wanted to secure the same thing I have taken for 2 years. I checked with other pharmacies and found they have none of the metoprolol succ from Wockhardt. The pharmacist said they now only deal with Wilson as they are in the USA. I am checking with my regular druggist to see where they get the new generic, and I think I will check in the future for all meds and where they come from.
    I am on Medicare and Blue Cross and they sometimes decide on their own what we should take, but with my severe allergies (I stop breathing) I try to retain what I have once I know I can tolerate it. Very grateful for this article, as it answered my questions and then some.

  4. SAA
    Reply

    I am currently taking Metoprolol Succinate Extended-release Tablets 50 mg once a day. I do not feel I am having any problems; however, I am concerned about the recall and do not know if I am affected.
    My medication is in the original bottle which lists the following information:
    NDC 49884-405-01
    Mfd. by: AstraZeneca AB
    S-151 85 Sodertalje, Sweden
    Mfd. for: Par Pharmaceutical Cos., Inc.
    Spring Valley, NY 10977 U.S.A
    Product of India
    PAR R12/10
    Pharmaceutical LA405-01-69-03
    Can you help me determine this$

  5. Marjorie g
    Reply

    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 “awaken”. RN.,BA.

  6. TLP
    Reply

    Metoprolol tartrate (generic for Lopressor) is not the same drug as the one they are talking about above, which is metoprolol succinate (generic for Toprol XL). Both are metoprolol, but one is long-acting (Toprol XL) and one is not (Lopressor).

  7. AnnieT
    Reply

    Thank you for this article,
    For a long time I have questioned the effectiveness of generics, particularly those from other countries.
    I too have had similar issues with Blood pressure management suffering real lows and real highs along with dizziness at times.
    Early on I started on Toprol XL then like all the others was steered into the generic Metoprolol succinate approved by cardiologist..
    I cannot begin to comprehend the how and why this country has allowed the importing of the majority of its drugs from countries that do not have the same standards as we once had. Oh I do $$$ but why do we allow it to continue?
    Every single day I receive FDA recalls and I am shocked at the amount of recalls on major drugs and IV solutions. These are life saving drugs not some insignificant Supplement. Scares me.
    What can we do ? Who can we turn to ? How do we demand safety once again
    Respectfully, Annie T

  8. Helen
    Reply

    The FDA has been playing games for years with Wockhardt in India. You contacted them in 2007 re: generic metoprolol and this is 2014 ! If the readers get on their computers and read all the FDA warning letters, import bans etc etc they will be shocked. A general search on Wockhardt problems will result in many many articles regarding all the problems, and yet we continue to let their generics come into this country. Between some doctors not admitting that there are problems with some generics, and the FDA not cracking down hard enough on some of these companies, it is just a losing battle for the patient.
    Everyone can look up their pills on drugs.com. There is a pill identifier that allows one to put the code, shape, and color of medications to find out exactly what it is and who manufactured it. Take the time to find out what it is in that bottle that the pharmacy gave you. People who don’t have computers can ask someone to do it for them. It’s important.

  9. Sharon B.
    Reply

    I have taken metoprolol for more than two years with no side effects.

  10. SN
    Reply

    My experience with generic metoprolol was troubling. My doctor prescribed 50 mg Toprol XL for PVCs but my insurance would only cover the generic metoprolol. At the time (2009-2010) the companies making the generic were Watson Labs and Par Pharmaceuticals. My first 3 months were with the Watson version and the PVCs were greatly reduced but I felt slightly lightheaded and seasick. After 90 days I refilled my Rx and got the generic from Par.
    BIG difference! I felt much worse: dizzy, off-balance, loads of PVCs – just plain awful. I called around to different pharmacies and checked to see if they used Watson or Par for their generic metoprolol before placing my next order and picking it up. This went on for a year, until I got new insurance and they covered the brand name Toprol XL at an *almost* reasonable cost.
    I happily paid the extra because while on the brand name drug I felt human again. No PVCs, much less dizziness, no seasickness. Unfortunately, the Toprol stopped working after a year and I had an ablation. All is well now and I’m drug-free but it scares me to think of all the patients who rely on this drug to control their symptoms and are forced by their insurance company to get the generic.
    I know from my personal experience that the generic metoprolol (from any company) just plain doesn’t work as well as the brand name.

  11. Gerald
    Reply

    After having a bad reaction to a generic toprol in 2007, I began using the AstraZeneca original 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 (it’s also the only med I take). To my knowledge there’s never been an issue with this generic, but I look forward to PP corroborating that.

  12. VL
    Reply

    I am so glad I read your comments. I also am having a problem with irregular palpitations (very strong) and also since I take my blood pressure every day (As per my cardiologist). I have noticed that it is much higher that it has ever been. I take metoprolol Succ ER 25 Mg at night and metoprolol Succ ER 50 mg in the morning. The 50 Mg. is made in India: company is MYLAN and the 25 mg. metoprolol is made by Par Pharmaceutical.
    I had an aortic valve replaced on Oct 28, 2011 and I am 80 years old. I try to be active but the pounding of my heart quickly scares me and I rest until it goes away. Thank you, Mrs. V. Lopez

  13. nese
    Reply

    Thank God for People’s Pharmacy!!!

  14. joe h
    Reply

    I continue to have problems with generic bupropion, it doesn’t seem to have the same release all the time if feel on some days like being on a roller coaster. No way will my insurance pay for name brand and I can’t afford to pay top dollar for it.

  15. Penny H.
    Reply

    My previous internist had me on metoprolol and Lisinopril for high blood pressure. He retired and I asked my new doctor if I needed both since my BP was always in the low normal range. She told me to stop the metoprolol. I did and my BP has actually dropped to an average of 98/60.

  16. paulbyr
    Reply

    What remedies do knowledgeable people suggest? I doubt there is a data gathering organization to record when people die because the drug they needed has vanished and been replace with a non-effective [Indian?] substitute.

  17. ET
    Reply

    This may help someone. Usually, the metoprolol was a small white tapered pill. My prescription was refilled with one that was white and asprin shaped. I only took a couple to experience an irregular heartbeat.
    I call the pharmacist and she exchanged the round pills. The problem stopped. I told my previous doctor what had happened and she said, “That couldn’t happen.” I said, “The pharmacist said it could.” Later my drug store was out of the small white tapered shaped 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 timed release.”
    Comment: When this pharmacist saw my retired military ID card, he paid for the prescription with the comment, “Thanks for your service to our country, my parents were Holocaust victims.”
    Another recent change that seems to be OK is the Micardis HCT has been changed to a generic: Telmisartan and Hydrochlorothiazide Tablets USP.
    Thanks

  18. SEH
    Reply

    I just picked up a renewal of my generic Metroprolol succinate ER 50 mg from pharmacy. It is generic made by PAR Pharm. Has this manufacturer had any issues with this drug?
    thanks

  19. Jackie L.
    Reply

    I have been using metoprolol for several years and have been having ongoing problems with blood pressure spiking for no apparent reason, irregular heart beat which is why I am taking this medicine and it doesn’t seem to be doing much good.
    As a result I am now also taking another blood pressure medicine called Micardis. I never really had high blood pressure and only started on medicine because of the irregular heart beat. Metoprolol slows your heart beat and really makes me very listless. Am not happy and am contacting my doctor today.

  20. Carla ARNP
    Reply

    My patients and I thank you for all the great work you do at the People’s Pharmacy! I love that you stay on the FDA trying to make our medications safer. I also appreciate all the non-pharmacological remedies you suggest.
    It’s wonderful to have alternatives to offer my low income and under-insured patients.

  21. Craig Donovan
    Reply

    It strikes me that many of the patients who have commented on the poor therapeutic effects of generic medications were at first on a branded pharmaceuticals. With all of the cost management going on in medicine today, I have to believe most patients are started on a generic version when one is available and in that case would never know the difference between an effective and ineffective response. Scary thought.

  22. J.Johnson
    Reply

    In January of 2013 I was admitted to the hospital with a-fib. They tried all sorts of meds on me and even did a cardioversion which did not hold. I continued to have the a-fib but was able to function pretty well on Rythmal, Warfarin and Lisinopril. In an attempt to stop the a-fib my cardiologist put me on Metoprolol Tartrate. I don’t know if this is a similar drug to what you are discussing.
    All I know is that within a few hours of the first dose I could not walk across my house without being short of breath and exhausted. And, the a-fib was worse. I was simply unable to function at all. It took me a couple of days to figure out that it was the Metropolol so I stopped it and went back to the original meds.
    Finally I was put on Amiodarone and another cardioversion was done which held this time. I was able to drop the dose of Amiodarone from 400 a day to 200 and then to 100 a day. My pulse stays in the 60s and 70s usually and I’m able to finally get back to my normal activities which means walking several miles a week.
    I have thought all along that my reaction to Metoprolol was because I’ve been unable to take any beta blocker. Now, I see this on your site and will certainly bring it to the attention of my cardiologist. Of course I am concerned about the many reported side effects of Amiodarone and my eye doctor is watching my eyes carefully for signs of amiodarone in the cornea. I did notice at once that it caused muscle aches and a phlegm producing cough, but, it allows me to function without a-fib. I’m 78 years old anyway. I figure the good outweighs the bad.

  23. M. Wood
    Reply

    I used the generic, metoprolol Succ and had the same result as tho I’d had food poisoning.
    I was switched to TOPROL XL (non-generic)with the dosage cut back 50%. It worked. This is strong stuff. I think doctor’s should start small and if needed, then work up to a stronger dosage.

  24. Tom P
    Reply

    How do I know if the pills I have are good/bad/recalled? My blood pressure is good but I’ve been experiencing some numbness and headaches lately?

  25. NGA
    Reply

    I have supraventricular tachycardia proximal and have been taking Metoprolol Tartrate ONLY when I need it for palpitations which happen about once or twice per month. I am very concerned, although I have not had any problems with my drug other than it sometimes takes longer to work.
    I was notified just this morning (e-mail) by Walgreen’s that they cannot refill my prescription. It is gratifying that they are on top of things!
    I was not aware that my medication was being produced in India. Had I known, I would have requested a change.

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