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. joann
    long island ny
    Reply

    Heart attack 2012, prescribed Metoprolol, taken without incident 4 yrs. Until this week when I landed in hospital with chest pain, pounding headache, dizziness & blurred vision. Tests all fine. Still had headache & spiking blood pressure, more test scheduled. Upon review the only thing different was a new bottle of metoprolol from PAR via CVS. Reverted to a leftover older bottle of pills and symptoms immediately resolve. Medical personnel quick to dismiss? I am reporting this to CVS, FDA, hospital & insurance.

  2. Ginnie
    Maryland
    Reply

    I’ve been taking Metoprolol ER for 6 years (with NO problems), since my sudden cardiac arrest. Since my last refill about a month ago my average heart rate has steadily increased. It got so bad that I finally went to my cardiologist yesterday and he said that there had been problems in the past with generic manufacturers. Sure enough, I went home and looked up the “new” manufacturer – Dr. Reddy’s, based in India. There was a recall on their Metoprolol in 2014, and they currently have 3 FDA sanctions against them. WHY are we distributing life and death medications made by a company that repeatedly receives sanctions? (And by the way… Dr. Reddy’s? Really? Why not just call yourselves “Bob’s Drugs”!) I was switched to PAR today. We’ll see how that goes, but if it’s not better I’m going to brand.

  3. SK
    North Carolina
    Reply

    For some reason my pulse got out of control [never had been] and my BP was also very high. I saw your article in April or May of 2016 and shared it with my physician. I checked and my Metoprolol was from India. My physician changed me to Toprol XL and the pulse came back to normal and my BP has dropped. I am very grateful for the information as posted by The People’s Pharmacy. I am also hoping the hair loss will stop but so grateful for the other. Thank you so much.

  4. CHARLES
    BAYSIDE NY. 11361
    Reply

    After taking PRINIVIL for about 25 years my nephrologist switched me to METOPROLOL succinate ER 25 mg.twice a day. It worked until my last refill at my pharmacy was manufactured by PAR PHARMA (my original pill was round with a score this one is oblong with markings A & B;i must say that my blood pressure has risen 10 %?? my cardiologist shrugged it off but I am convinced that this pill is not doing its job;am I putting myself in jeopardy???

  5. Dani
    Reply

    I just looked at my bottle it says:
    METOPROLOL ER SUCC 25 MG.
    PHARMACEUTICAL: PAR
    Is this the Pharmaceutical that every one has had an issue with?
    Any issues with TOPROL XL and the Pharmaceuticals?

  6. Dani
    Midwest
    Reply

    Iam a 54 yr. old female, was put on Metoprolol ER Succ 25mg. for Severe Migraine Prevention by my Cardiologist. Iam healthy, other than migraines, & a mild heart murmur. My cardiologist said I can’t continue to keep taking Relpax, & Imitrex 3-5 x’s a week, so he gave me Metoprolol ER Succ 25mg..
    As a preventative for severe migraines. Well all was great in the beginning, 5 weeks ago. Headaches were less often. But now I’m having adverse effects such as: palpitations, very nervous, weak feeling, burning pain in back, & top of head, blood pressure goes really low 110/70, pulse 45, then at night might be 150/86, pulse 64, before my next dose.
    I looked this medicine up & found out that there are others with the same side effects. I called my doctor today & asked to be switched to the brand name TOPROL XL..we shall see! I can’t continue & refuse to feel this way. It’s awful for me. Good Luck! :)

  7. Carolyn
    Cleveland, Tenn.
    Reply

    I had been taking toprol XL for years and had very few problems over those years with my irregular heartbeat. Then I was switched to a generic (metoprolol) .then I started having alot of problems with my irregular heartbeat. I made them give me the name brand back.I just started taking the name brand but it is not the same name brand pill I was taking before. The first name brand pill I was taking worked wonderfully but this name brand pill looks just like the generic one I was taking, in fact practically identical and so far it’s not working. I’ve been taking it for 3 or_4 days. It concerns me that it may not be a name brand. I just know that the original name brand pill worked so well and this one is different and it doesn’t seem to be working and that is the only change I’ve had . I can’t see anything that could be causing the problem. I feel that the problems with medications should be looked into alot more carefully. We are depending on the pharmacutical companies to do their jobs correctly. But obviously they seem to be filling to do so. My prayers are with everyone having these problems.

  8. Jessica
    Charlotte, NC
    Reply

    I have been taking the metoprolol succinate 50 mg for a cardiac arrythmia, PVCs. Before I left for my vacation, I had the 6 week follow up with my cardiologist to see how things were going. All was going well, medication was working and I felt much better. When I returned from my vacation, I received my new prescription bottle in the mail ( I had to switch pharmacies due to a new health plan) and after taking the new prescription, symptoms returned after 6 weeks of feeling great. Nothing else changed. I called the pharmacy about the manufacturer. The oblong shape from Par-pharm was very effective for me but the round pill marked M2 did not work for me at all, with symptoms of palpitations and increased anxiety (due to palpitations). The point is, pay attention to the manufacturer. …there are differences! I have to unfortunately pay out of pocket for the better manufacturer.

  9. elaine
    boston
    Reply

    Also had hair loss on metoprolol I am now on lower dose. But have been suffering from anxiety on it cardiologist doesn’t think it’s from metoprolol but didn’t have it before like this

  10. Joan
    Florida
    Reply

    I began to have problems with Metoprolol and was becoming a zombie, along with irregular heartbeats, trips to the hospital, etc. So, I began reading on my computer. I saw that this generic drug was having problems, and they all sounded like MY problems. I inquired of my insurance company and was told that I would have to pay for my TOPROL XL – and so I did! What a difference! Now and then my blood pressure rocks and rolls, but much less frequent, and is usually due to my eating habits, etc. No way will I be convinced to try Metoprolol again. Also, if it is so evident that these generics can be dangerous – why then do our insurance companies refuse to pay for the real thing???????????

  11. Laureliete
    United States
    Reply

    Toprol Xl does not have the inactive ingredient hypromellose. This flowery sweet name was changed in the last few years from hydroxypropylmethylcellulose. And with very little close to no fanfare at all. Very deceptive. It IS in some of the metoprolol generics. Watson brand for example is one. I can’t take hypromellose. Twice it was in a drug I took daily. The first time I ended up in a coma with heart failure, liver failure and kidney failure. I had no risk factors at all. I’m lucky to be alive. The second time worsened the heart failure from the first time. Two different drugs both with hypromellose in common. No other daily drugs I took had that in it. It could be a coincidence but I’m not willing to risk my life. Last year went on one more drug with that same inactive ingredient and saw my liver enzymes begin to soar within the first two weeks. Went off that drug immediately. It is not the same as cellulose compounds don’t know why Watson would substitute it so unnecessarily. It must be cheap because it is showing up in everything from aspirin to face wash. By the way it is also used in industrial adhesivives. Go figure!

    • Donna
      Indiana
      Reply

      I am on Metoprolol Succ ER and have been having PVC’s, I also have other heart issues but these PVC’s are driving me crazy, and after reading all these stories I’m beginning to think it is this generic medication. I’m going to call my Dr. and request Toprol XL, and see what happens I to will have to pay for the name brand but it will be worth it. Has there been any law suit against this manufacturer?

  12. paul
    Reply

    I am 60 years old and was switched from a beta blocker to a channel blocked ( metoprolol) 7 years ago. It was actually my ex wife driving by that started the paul is losing his hair rumor in an excited way.

    I ignored her gossip until a couple years ago when I realized I was shedding hair faster than my black lab.

    It was everywhere… in my hat, intertwined in my eyebrows, (also thinning disproportionatly), stuck In my glasses, on my robe, on my shoulders in the vacuum even.

    I am not a vain man but when this became more than annoying I noticed the hair falling out was really really thin and enimic looking.
    I did some research and found one of the side effects of metoprolol was hair loss. But it was so far down the list ait was in the very rare catagory.
    I do not believe them.

    As of last week I stopped taking metoprolol 200 mg and also amlodepine cold turkey.
    even though my doctor had assured me my pulse would skyrocket in 48 hours without it, my pulse and blood pressure have actually improved. 138/78 pulse of 98.

    I don’t care if I drop dead today, as long as I don’t lose any more hair!!

    signed… waiting for hair

    • The People's Pharmacy
      Reply

      We do not advocate stopping blood pressure medication suddenly, and urge those on blood pressure pills to get their doctors’ guidance for getting off.

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