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FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility

Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

There is yet another apparent quality-control problem in the generic drug manufacturer sector.  This one involves Sandoz, the generic drug unit of Novartis AG (NVS), and its metoprolol succinate ER tablets, which is a generic form of AstraZeneca's Toprol XL.

An August 26, 2008 Reuters article, "UPDATE 1-US warns Novartis generic unit on plant problems", provided this information from an FDA letter about the problems found by inspectors at a North Carolina Sandoz manufacturing site:

"We question the continued distribution of this product until better process controls are implemented and process validation is completed," the FDA letter said.

"We are also concerned that the problems noted in the metoprolol validations could be indicative of problems and poor decisions made with other product validations," the agency said.

Novartis sought to downplay this August 2008 FDA warning letter to Sandoz, according to the August 26 Reuters article:

Novartis spokesman Eric Althoff said the FDA's concerns were "primarily about documentation and validation."

"We are working together with the FDA to solve the problem," he said.

It is unclear as of August 26 whether Sandoz will cease distribution of its metoprolol succinate ER tablets (generic Toprol XL) and/or issue a recall of this medication.  We will be watching for these possible related developments.

In addition, we will post a link to the Sandoz warning letter regarding its metoprolol succinate ER tablets (generic Toprol XL) when this letter is available on the FDA web site.

P.S.  This August 12, 2008 FDA Warning Letter (08-ATL-13) concerns the Sandoz manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina.  (8/26/08)

61 responses to “FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility”

  1. Mike Gordon Avatar
    Mike Gordon

    I have been on Metoprolol Succ ER for 2 1/2 years. Should I be concerned?

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Mike:
    The nature of the manufacturing problem at this NC Sandoz plant remains unclear, still. As such, I cannot tell you whether there is any safety aspect to it.
    You should speak to your doctor and/or pharmacist if you are concerned about your current or future supply of metoprolol succinate ER tablets (generic Toprol XL).
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. William Roberts Avatar
    William Roberts

    I have benn taking this drug for about a year and am just now finding out about the recall, How could this drug negatively affect me? The phammacy where I trade had little or no info regarding this except that they were replacing it with the same drug made by ETHEX. These pills are much larger than the former ones and I would have difficulty in swallowing them. Any sugestions?

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    William:
    I have not seen any recall notice for these metoprolol succinate ER tablets by Sandoz (Novartis), so I do not know if there is any safety aspect to it.
    As stated in the article, there were quality-control issues that the FDA identified, and when you are dealing with a prescription drug one would imagine that making an “out-of-specification” pill could cause dangers for the patient taking it.
    If you or someone else could send me a copy of any Sandoz metoprolol succinate ER tablets recall notice they have received, I would appreciate the opportunity to review it.
    I hope you keep reading Drug Injury Watch.
    Tom Lamb

    Reply
  5. Millie S. Avatar
    Millie S.

    Today when I tried to refill my Metaprolol, I found I could only get the larger sized generic – that is how I found out about this
    recall issue. Rite Aid pharmacist told me that I should be receiving a letter in the mail with an address on where to send the balance of the pills for a refund. I called my cardio DR and had him issue a script for brand specific drug instead. I had been feel great at the end of 2007 and have been feeling poorly most of this year – I’m wondering now if this pill was a factor.

    Reply
  6. Tom Lamb Avatar
    Tom Lamb

    Millie:
    I appreciate you providing us this insight about the Sandoz metoprolol pill recall.
    There has been no information from Sandoz nor the FDA since we first learned in late August about the manufacturing problems at the Wilson facility.
    I do not know if this apparent pill defect has a safety consequence associated with it.
    If you or someone else can send me a copy of any letter received from their pharmacy, Sandoz, or their agent who will be collecting the pills for them, I would welcome the opportunity to review it and learn more about the situation.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  7. Phil Church Avatar
    Phil Church

    I was switched to the Sandoz drug about a month ago and about two weeks later started experiencing light headedness. Doc can’t find any reason for that but I am suspicious. Anyone else notice any symptoms?

    Reply
  8. Tom Lamb Avatar
    Tom Lamb

    Phil:
    Insofar that there has been no additional information from Sandoz nor the FDA regarding this defective drug situation, it is unclear whether there is a safety issue related to these generic metoprolol pills. As such, like you, I am hoping that others may share their experience with the Sandoz metoprolol ER pills that might be “out-of-specification” due to faulty manufacturing.
    If you have any information for Phil and me about the Sandoz metoprolol pill causing any side effects, please post a Comment.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  9. Sherry Avatar
    Sherry

    I have ben on Metoprolol for quite awhile, a little over a month ago I started having odd symptoms of dizziness, nausea, rash, anxiety, heart palipitaions, sweats and the loss of taste. My doctor has been running tests for weeks with no luck in finding out what was causing this. I told him about the recall and WE truly believe it was this medication. I did not find out about the recall until I tried to refill my RX at RiteAid and was told about the Recall. They did not offer any explanation at all, I had to do all the research myself and I have seen many many articles from folks with the same if not more symptoms I have been experiencing. Now I am trying to get the RX Insurance to cover my new prescription of name brand (Toprol XL) but they are balking at it since there is a generic. If anyone has any other info, please post it here.

    Reply
  10. Tom Lamb Avatar
    Tom Lamb

    Sherry:
    I appreciate you taking the time to share your experience with metoprolol ER / Toprol XL.
    You certainly are entitled to feel frustrated at this “silent” recall apparently being done by Sandoz months after the manufacturing problems were found by FDA the Wilson, NC Sandoz facility. For neither the drug company nor the FDA to address the safety concerns of you and numerous other patients seems to me to be irresponsible, at least.
    If anyone gets a hold of some documentation from Sandoz or their pharmacy about this metoprolol succinate ER recall, please send it to me so I can share this information and material with those who are searching for it.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  11. Maridsa Avatar
    Maridsa

    I have just found out about this recall when I went to refill, like others have mentioned–I am really upset that I had no prior notification of this from Rite-Aid and the pharmacist would not give me any information. I am very concerned now b/c I have been sick for over a month with SOB and hoarseness, dry cough, I ended up with Bronchitis but this hoarseness and SOB is still lingering a month later, I will see Cardiologist. Prior to this I was already wondering if it could be the meds. Does anyone know where I can file a formal complaint about the poor handling by Rite-Aid and where we can get more information about what effects this drug has possibly had to our health? Just not sure what next steps to take and I don’t think we should be silent on this, someone better start giving some answers-this is our health we’re talking about and I agree that it was working in 2007-what’s happened in 2008?

    Reply
  12. Kelly Ford Avatar
    Kelly Ford

    I was on the ETHEX generic and then switched by my pharmacy to the Sandoz generic. Within days I began having heart palps, which is the reason I was on the meds in the first place, to decrease the palpitations. After 2 weeks of just feeling strange, finally called the pharmacy and they put me back on my old generic, and I felt better within days. I thought it was all in my head, but maybe not after all…

    Reply
  13. Tom Lamb Avatar
    Tom Lamb

    Maridsa:
    As far as the conduct by RiteAid, you may want to contact your state’s Pharmacy Board to let them know that you are disappointed about the lack of disclosure concerning this apparent recall of Sandoz metoprolol succinate ER pills.
    Of course, if you find out anything of interest, please share it with us. There are plenty of others who are in a similar situation; see:
    http://www.topix.com/forum/drug/metoprolol/TGANVJMN2DENR57B1
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  14. Tom Lamb Avatar
    Tom Lamb

    Kelly:
    Many people have been left wondering about this metoprolol succinate ER tablets recall and whether there is any safety aspect to it.
    If you or anyone else gets real / substantive information about the “problem” with these metoprolol succinate ER tablets by Sandoz (Novartis) from the drug company, the FDA, their pharmacist, or their doctor, please share it with us, here.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  15. Deb Hilton Avatar
    Deb Hilton

    I’ve been sick the last few months on the generic. Just talked to Rite Aid pharm. about recall. He said it was strictly a packaging issue, but offered to switch my pills for me. Rockford, Mich. Rite Aid store.

    Reply
  16. Tom Lamb Avatar
    Tom Lamb

    Deb:
    I appreciate the report on what you were told by your pharmacist.
    To others, is what Deb was told in Maine consisitent with what you were told by your pharmacist?
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  17. Cindy Jo Aguilera Avatar
    Cindy Jo Aguilera

    My mother has been on Metoprolol Succ ER by Sandoz for 1 year now. A few years prior to that she was notified by her eye doctor that she had signs of macular degeneration. Every year since, she’s had eye appointments and doctors noted very little, if any changes. Now after she has been on Metoprolol, she has shown significant changes in the Macular Degeneration and was diagnosed legally blind. We feel this medication is the reason the macular increased rapidly. Has anyone else complained about loss of eye sight? Thanks Cindy

    Reply
  18. Tom Lamb Avatar
    Tom Lamb

    Cindy:
    I do not have any information about an association between Macular Degeneration and the use of Metoprolol Succinate ER tablets made by Sandoz or other types of Metoprolol.
    Does anyone know of such an association? If so, please share your information with Cindy and other readers of this post by submitting a Comment, below.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  19. Eve Avatar
    Eve

    I am not surprised and expected this to happen.
    After taking the “Sandoz” metaprolol last spring I knew within a fifteen minutes that the drug did not come close to the brand-name Toprol XL nor did it even seem to be in the same family of drugs.
    I actually began to feel as though I were having angina attacks or worse. My breathing became difficult and I was beginning to sweat.
    The drug at first glance looked like the brand Toprol XL, however, upon closer inspection it became obvious that these pills were poorly made. The edges were uneven and looked as though they were crudely cut. All thirty pills – with their raggedy edges – seemed slightly different from one another with those raggedy edges.
    Never again will I take a blood prssure medl. that is a generic. It’s not worth my life to save a few bucks.

    Reply
  20. Tom Lamb Avatar
    Tom Lamb

    Eve:
    Your firsthand account of what these possibly defective Sandoz metoprolol succinate ER tablets (generic Toprol XL) looked like will, no doubt, help other readers with their situations.
    The quality of generic drugs has been cast into doubt as a result of the several different recalls of generics we witnessed in 2008. Besides this Sandoz generic Toprol tablets recall, we had: the “double-dose” Digitek recall involving Actavis and Mylan; followed by recall of all generic pills manufactured at Little Falls, NJ, Actavis plant; and, then there were the first, second, and third recalls by ETHEX / KV Pharmaceuticals….
    For the details about these 2008 recalls please see:
    http://www.drug-injury.com/druginjurycom/generics-efficacy-safety-gmp-quality-control/
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  21. Kim B Avatar
    Kim B

    I’m just in shock! I’ve been on metoprolol succ er for several years and had NO idea about any recalls until today when (JAN 8, 2009) I opened an email from FDA recalls and followed the link to find metoprolol listed as being recalled. Doing further research I found and printed many copies of notes on recalls from different mnfr’s from dates back to 2006.
    I also use Rite Aid, and have a few bottles kept from june/sept/nov-29 from mnfg; santoz.
    I had called rite aid a few times last year regarding different sized pills when getting a refill, they told me it was a different lot or company, nothing to worry about go ahead and take them…never a word about a recall.
    I’ve had lots of problems over the years including, hair loss, breathing problems, vision problems=came on very sudden, I’m an avid reader, and in one months time I could not read a book without magnifying glasses. (I’m thinking this started when I started taking this medicine, but not sure) I also had a point where I had to make a dr’s apt. left eye was pouring tears out and would not stop. In early 2008 I had an episode w/heart palpitations, it’s normal for me to have a few here and there, but this was very scary, it started all of a sudden and lasted all day and all night. I couldn’t even sleep due to the palpitations. At that point I started taking my blood pressure at home because I just wasn’t feeling right. I was amazed that my blood pressure readings were so low, some were 89 to 90ish over 50-54, my normal is usually 135 and up, over 78 to 90. I ended up at the ER due to palpitations and I Went to dr. after that, he ordered some tests and a stress test. I had showed him a chart w/ blood pressure readings and was told that is great! As Part of the stress test, I had to stop Metoprolol for 3 days prior to the test, so I did (I started to feel better) I went to complete the first part of the test, and was told to come back for the 2nd part, well the dr had to cancel & it was over a week later when I completed the test, making a total of several days off the med. I felt better, so I started taking just 1/2 the 25mg pill and keeping an eye on B/P, I called the dr and told him of this and he agreed to take a 1/2 ..BTW stress test came out ok, but something about the lower part of heart..I can’t think of this now, but he said it was all ok nothing to worry about right now. When I first started taking this I would have bad anxiety/breathing difficulty, I even called the dr about it, was told it’s ok, take it. I have anxiety and copd anyway, but this was worsened within a 1/2hr after taking, so instead of taking it in the morning I would take at night so it didn’t completely ruin my day.
    Well tonight Jan 8 2009 I called rite aid and asked them why I hadn’t been notified? And why…do I have a prescription dated NOV 29th from manufacturer SANTOZ? I said as of now I’m still taking pills you filled for me on Nov 29th by mfr;santoz. I was told that it was from a different lot and labeler was PAR pharm. I said yes but still manufactured by santoz? and at that time I opened my new prescription dated dec. 29th (that I hadn’t started yet) to find large round white pills..I looked at the label and to my amazement, my doctor had wrote the prescription for 50mg instead of 25(remeber I only take 1/2 of 25mg)jeeesh!
    Wow, I’m sorry this is so long but I’m just amazed by this! Beleive me I will be calling my doctor tomorrow, I will be requesting a new medicine. And thank you for this place to vent, I sure needed it after the last few hours I’ve had!

    Reply
  22. Kim B Avatar
    Kim B

    RE;Deb Hilton
    I’ve been sick the last few months on the generic. Just talked to Rite Aid pharm. about recall. He said it was strictly a packaging issue, but offered to switch my pills for me. Rockford, Mich. Rite Aid store

    Deb I was told practically the same thing, allthough I have proof by the saved bottles that until Jan 7th, 2009 I was taking Sandoz generic. The pharmacist at rite aid told me that the labeler was PAR pharm, and when I questioned him that the manufacturer was still SANDOZ he gave me a brush off saying I should talk to my doctor if I didn’t want to continue this medication. BTW this prescription was filled on NOV 29th 2008..after the recall, it was suppose to last me 2 months. He told me this wasn’t the type of recall that patients needed to be alerted too, which I replied, this is my heart we’re messing around with here I think I should be notified!

    Reply
  23. Tom Lamb Avatar
    Tom Lamb

    Kim:
    Sorry for the delayed response.
    I completely understand your frustration and unhappiness as regards how this Sandoz pill recall is being handled by the pharmacy you use.
    Certainly, 2008 was an “eye-opener” when it comes to the quality of generic drugs. We have learned that a generic pill may not be what it is suppose to be, as a result of improper manufacturing practices in facilities located here in the U.S. — not overseas somewhere.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  24. Kim B Avatar
    Kim B

    Thanks Tom,
    Your so right, it is an eye opener that this is happening.
    Our government should have a handle on this and should pass strict laws and practices in regards to generic drugs (and many other things, such as food) here in the U.S.
    Sadly, even when a person can get a non-generic prescription from the doctors, our insurances won’t cover them if the generic is available. Unless you can afford to spend sometimes hundreds of dollars a month, there are no choices.
    U.S. Government our own worst enemy?

    Reply
  25. soren Avatar
    soren

    I have been taking metoporolol for at least a year and within the last month I have been having pain in my chest and back. I was also having a shortness of breath and was lighthead. It got so bad I went to the ER. the doctor said my chest xrays were fine so he gave me medicine for pluralcy which after reading about, didnt seem like what the problem was. the doctor said he didnt know why I was feeling light headed. so today i call my pharmacy and they tell me metoporolol has been recalled. and so now im wondering if this has anything to do with the problems ive been having latley. Is there any way to find out why it was recalled?

    Reply
  26. Tom Lamb Avatar
    Tom Lamb

    Soren:
    As for “why” the recall, that question should be put to your pharmacy and/or the drug maker.
    Concerning your inquiry about whether your symptoms were possibly related to your use of the metoprolol succinate ER tablets (generic Toprol XL), I cannot answer because I am only an attorney and not a medical doctor.
    I do understand why you ask these questions, and I’m sorry I am not able to give you the answers.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  27. Susan Avatar
    Susan

    Hi all, glad to find you! I took brand name Toprol 50 mgs for years to prevent rarely occurring hormonal tachycardia, but my heart is healhty. My body loved the brand name Toprol – until the generics came out. They upped the price of the brand name out of my price range so I switched to the “new at the time” plain jane generic Toprol a little over a year ago I think it was.
    BRAND NAME TOPROL 50 mgs APPEARANCE: round, flat white pill similar to aspirin.
    MY FIRST GENERIC TOPROL APPEARANCE: exactly the same as the brand name, flat and round.
    THAT GENERIC STUFF MADE ME SICK IMMEDIATELY. I had sudden horrible dizziness that almost made me pass out. Also gave me palpitations, racing heart, the feeling of extremely low BP but it was actually way high (my normal is 110 but drug made it over 140). Also severe, relentless headaches. And frequent bouts of burning, watering and crusty eyes all day long, they even turned red at times. It was related because I have better than perfectly healthy eyes. Also have a lot of hair loss but I have so much it’s always coming back lol. ANYWAY…my doctor kept saying she was very confused why that first generic toprol would make me sick, it’s the same drug, and that it had to be the 1% of whatever they put in it to “package” it that’s different between manufacturers, that was what was making me sick, so she agreed I try a new one.
    I got off that poison generic within a few weeks (thinking I would just need an adjustment period) and switched to atenolol, which is a little strong for me since I don’t have a BP problem. Generic toprol symptoms disappeared immediately but wasn’t happy long term with the atenolol and doc recommended generic metatoprol ER 50’s. (I think the bad one was ES but can’t remember.) I’ve been on the ER’s for a year and they are NOT as good as the brand name Toprol but they seem to be ok – and look totally different! Sometimes, I don’t feel right on it though, so I wonder. I still get occasional racing heart (which is a healthy heart) when on the brand name Toprol I was never aware of my heartbeat at all, was great stuff.
    APPEARANCE OF MY CURRENT METATOPROLOL ER 50 mgs: a big white football, not round and flat.
    I just found out BY ACCIDENT at my pharmacy tonight, while filling a different Rx, that next week when I see doc for routine metatoprol ER renewal, I’m out of luck b/c the drug is recalled. I was inquiring about my Walgreen’s long term program and price and they went – WHOOPS – it was a nationwide recall by all manufacturers and that I have to see doc for a replacement. A pharmacy employee jumped in and added “it may be back in about six months.” None of them knew what the problem was.
    I apologize I don’t know yet which manufacturers’ drugs I’m taking but I bet that first one that was round and flat (50mgs) was the bad batch, and my current football shaped metatoprol ERs are not the bad batch, but just not effective as the brand name. That’s my guess. I’ll research this further and come back if I get any new info from my doctor next week that could help others. I need a beta blocker, but not a BP drug so it’s tricky with me. I’m considering returning to the expensive brand name Toprol and will just have to not eat to pay for it. Or will discuss a new one altogether with doc.
    I’ve filled at least two Rx’s of my football shaped 50 mgs metaprolol ER’s AFTER the recall and no one said a single word to me. I agree with others wholeheartedly (pun intended) who are saying “it’s my heart and I should have been notified.” Not only that, what I haven’t seen mentioned yet is that beta blockers and BP drugs are long acting and your body needs to adjust to these when you change brands and types. I’m sick and tired of putting my body through these adjustments back and forth, over and over, messing with vital organs in my body, all because of insurance issues, or brand names, or generics, or mislabeling or miscommunications, or shelf life ineffectiveness, or worse. It’s time we take control and I worry that any “new era” centralized healthcare changes in the next four years might make this worse.
    Other than communicating amongst each other, what can we do?

    Reply
  28. Tom Lamb Avatar
    Tom Lamb

    Susan:
    Thank you for taking the time to give us this detailed account of your experience with Toprol and its generic, metoprolol succinate ER tablets.
    If anyone develops a serious side effect for which they were hospitalized and that event is linked to a possibly “defective” metoprolol succinate ER pill — or any other pill that is out-of-specification, e.g.,”double-dose” — there is a possible personal injury product liability lawsuit to be filed against the drug company.
    If there is such a possible lawsuit, one should keep and preserve: the remaining suspect pills; the pill bottle; and, any documentation related to the prescription and/or the pills.
    One should NOT surrender possession of their remaining pills to the drug company or the pharmacy because, as you can understand, then a critical piece of evidence is no longer available for use in connection with any lawsuit (or any future investigation of the incident for other purposes).
    Due to this metoprolol recall by Sandoz, the three generic drug recalls by ETHEX in 2008, and the Digitek recall by Actavis / Mylan earlier last year, there are many people who have begun to doubt the efficacy and safety of generic drugs — as you expressed in your Comment.
    Hopefully, the “new” FDA will step up its monitoring of generic drug manufacturing facilities, here and abroad, going forward.
    Please feel free to contribute, again, to this “conversation” by submitting another Comment if you learn something new or have any follow-up questions.
    Have a good day.
    Tom Lamb

    Reply
  29. Cheryl B Avatar
    Cheryl B

    I am furious. I’ve been on Toprol for several years, but was put on the generic in fall of ’07. Since that time, have experienced hair loss, uncontrolled rise in my blood pressure, and red splotches on my legs that don’t go away. Also other weird tingling and numbness. I questioned whether it was the generic, but my dr. assured me it was “just the same as brand” and her response was to put me on yet another med! Only reason I found out about the recall and problems was a casual offhand remark by my pharmacist this morning regarding a recall. Looking on the internet, I see it’s been a while, and yet NOBODY told me. I am going back to brand and having a serious talk with my doctor about keeping me out of the loop. It’s MY health!

    Reply
  30. Susan Avatar
    Susan

    Thank you Tom for your reply. I see I am in no way alone. I did not go to the ER and did not incur any expenses so seems I have no evidence-backed claim in a lawsuit or class action. I’m sure many are also in that same boat.
    My question is this: Even if we didn’t incur expenses from harmful effects, how do we know that this drug hasn’t done any permanent damage to our bodies? I am still currently taking my football shaped Metatoprolol ER succinate 50mgs until I see my doctor this week. Am I doing any harm? You can’t just stop taking a beta blocker. I will be asking my doctor that question this week.

    Reply
  31. Tom Lamb Avatar
    Tom Lamb

    Cheryl B:
    In defense of doctors and pharmacists — at least as regards the period of time before these generic metoprolol recalls were announced — I believe most would not have suspected that the FDA-approved generic pill was not the “same” in terms of efficacy and safety.
    Things have changed, however, given all that came to light in 2008 with regard to generic pills not being what they were suppose to be….
    I completely understand your outrage, just trying to help you put it in the right direction — the drug companies and, perhaps, the FDA.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  32. Tom Lamb Avatar
    Tom Lamb

    Susan:
    Good to hear back from you.
    To start, as the FDA advises, one should not stop taking any prescription drug before talking to their doctor.
    If you are visiting your doctor this week, you may want to take your bottle of Metatoprolol ER succinate 50mgs with you for the doctor to inspect.
    Feel free to share with us anything you learn from your doctor which you think may benefit others facing this same predicament.
    I hope you will continue to read and contribute your insights to Drug Injury Watch.
    Tom Lamb

    Reply
  33. Susan Avatar
    Susan

    Glad to contribute Tom. See my doctor tomorrow and I will follow up here. Here’s what I’ve learned so far after spending hours on the phone w/ my ins co and 2 pharmacies:
    – After the recall and then the withdrawl of all generic forms, now the brand name TOPROL is not available at Walgreens or Walmart “due to the demand” of people going back to it after stopping the generics. Therefore, I’m required to change to an entirely different drug.
    – 2 pharmacies tell me that most doctors are switching people to the generic Lopressor to replace my Metatoprolol ER. Generic Lopressor is a 12 hour pill, so since I was on 50mgs once a day of Metatoprolol ER succinate, one pharmacy told me I have to take a 50mgs generic lopressor every 12 hours and the other pharmacy told me I’d have to take a 25mgs generic Lopressor every 12 hours LOL. I’ll let my doctor determine that. The problem is, the generic lopressor MIGHT be the first generic pill I took when I came off the brand name Toprol but I can’t determine that – it might have been the metatoprolol ES that made me sick but the pharmacy can’t find it. I’ll get the info from my doc which one made me sick – I know she has a record of it.
    – The manufacturer of my current Metatoprolol ER succinate that I am taking now is indeed ETHEX.
    – PHARMACY TOLD ME THAT THERE WAS A METATOPROLOL OUT TEMPORARILY MADE BY A COMPANY CALLED SOMETHING LIKE “TAR” BUT IT WAS STOPPED. I wonder if that’s the one that made me sick???
    – My ins co told me if I can find the brand name Toprol which costs $40 for me, and I want the $25 price since no generic is available now, then I would have to get receipts from my pharmacy proving the price difference and then try to recoup my refund from the manufacturer directly. This makes me mad b/c if no generic if available I should only have to pay the standard $25 and not the $40 but my ins co has not changed the price for brand name Toprol, still $40. But this is a moot point since brand name Toprol is not even available until they can make more to meet the demand.
    My insurance co, a major, popular one, indeed has a recall for generic Toprols in their system but the rep on the phone had absolutely no idea it was there until I told her and she is taking it to her supervisor.
    For those who want to take the generic Lopressor 12 hr pills, they are available at Walmart for $4.
    Bottom line for my doctor tomorrow:
    – Is the brand name Toprol available anywhere that she’s aware of since that’s my drug of choice? And if so, I have to pay full $40 for it then recoup the $15 deviation from my normal $25 price for each Rx directly from manufacturer.
    – Will the manufacturer of brand name Toprol FIGHT the requests for refunds and will we need an attorney for this, if that route does take place?
    – If brand name Toprol is not available, when will it be?
    – If the metatoprolol ER succinate becomes available again, when will that be?
    – Is the generic lopressor substitute for metatoprolol the same one that made me sick before?
    – Is the generic lopressor that best drug for me since I prefer 24 hr beta blocker over a 12 hr beta blocker?

    Reply
  34. Susan Avatar
    Susan

    I also wanted to add that I’m really confused now. My Metatoprolol ER succinate 50mgs are made by Ethex. The initial FDA warning for this generic was was re: this drug made by Sandoz. So why is the one made by Ethex also recalled??? This makes me think the problem is with the drug itself, regardless of who manufcturers it. I can’t wait to stop taking it, tonight is my last one.
    Not only is the Ethex one also recalled, I found someone’s post that Ethex has the following statement on their website:
    On behalf of the ETHEX Corporation, a subsidiary of KV Pharmaceutical, thank you for your inquiry regarding Metoprolol succinate ER tablets. If you or one of your patients have experienced an adverse drug event (ADE) to ETHEX Metoprolol succinate ER tablets, please call our Medical Communications Department toll-free at 800-321-1705, ext 3790, so that we may document this per FDA regulations.

    Reply
  35. Tom Lamb Avatar
    Tom Lamb

    Susan:
    Ironically and unfortunately, both Sandoz and ETHEX have recalled their generic metoprolol tablets, now.
    To be clear, (at least as I understand the situation) the problem is not about the drug metoprolol but about the fact that these two companies have made their tablets “out-of-specification”, meaning that they have mis-manufactured their metoprolol tablets — and that is why they are being recalled.
    In fact, ETHEX and its parent companay, KV Pharmaceutical, have recalled every generic drug that it manufactured (and has ceased production of any new generic drugs) due to systemic quality control problems that have been found at its manufacturing plant.
    I am anxious to hear your report, here, about how your doctor handled the set of questions you have prepared for your office visit today. Keep in mind that you may be more informed about the current metoprolol pill situation than your doctor given the extent of your investigation to date.
    Have a good day.
    Tom Lamb

    Reply
  36. Joyce Ann Coates Avatar
    Joyce Ann Coates

    I have taken Metoprolol ER 200mg ever since they came on the market ,several years I think .Originally I was on toprol 2oomg I have asthma and felt short of breath on both and headaches,but concerning the vision I have gotten worse an worse but never conected with the meds. I had to get new glasses still cannot see well have a new condition dry eyes.I am not able to see T.V keep blinking.Yes I do beleive it is connected to the meds.

    Reply
  37. Tom Lamb Avatar
    Tom Lamb

    Joyce:
    While it is my aim, here, to get information and news about prescription drug side effects to people like you who need it, please know that I am not a medical doctor nor a health care provider.
    Any serious health concerns you have should be addressed to one of your doctors.
    For an in-depth investigative report on another generic drug manufacturing problem, this one concerning Digitek (digoxin) and Actavis, see:
    “Did the FDA Miss Signals on a Troubled Heart Drug?”
    http://www.publicintegrity.org/articles/entry/1100/
    I encourage all who want to get a better idea about WHY there is this current Metoprolol recall to take a look at this report about the Digitek “double-dose” pill situation.
    Take care.
    Tom Lamb

    Reply
  38. T. McManus Avatar
    T. McManus

    Today I received a call from CVS informing me that the Metoprolol EC I have taken for nearly a year had been recalled and backordered with no indication of when or if it would again be available. Being a quality assurance practitioner for 30 yeras I was naturally curious as to why, given that the Pharmacist could not tell me why. The link below that was found in the postings here provided a shocking analysis from the FDA as to why. The total lack of quality protocols and validation data, coupled with what can only be described as complete and utter disregard for the consumers was shocking to say the least. The method whereby an alternate lot from a different population was used to qualify a previously known deficient lot(s) is in conflict with Quality Assurance 101 !!! Any first year quality professional would know this, and it is with complete shock that I read the methods used by the drug company’s that manufacture this medication. They should be subject to ennormous punitive fines and strict oversight by the FDA or other reputible entity. Allowing this medication to remain on the market for this many months speaks volumes regarding where their priorities are. I generally will never post to a blog, but this one is close to my heart, literally, and figuratively and these uncaring, irresponsible drug companies have not heard the last from me on this one. Here I was believing my blood pressure was running high due to my errors in health management, when the more likely root cause was their need to line their pockets at the public’s health expense. Geeeeezzz
    http://www.fda.gov/foi/warning_letters/s6891c.pdf

    Reply
  39. Cathy Avatar
    Cathy

    I just found out about the recall today from a pharmacist at a CVS pharmacy, my regular pharmacy is Rite-Aid. I called in refills for my meds on Friday 2/13/09, when I stopped after work to pick them up I was told the metoprolol was not available but was not offered any explanations, when I arrived home there was a message from my doctor about changing my medication. I stopped at a CVS pharmacy today to see if they could fill my prescription for me that is when I found out about the recall, I am also very angry with both Rite Aid and my Doctor, I saw my doctor in November to pick up new prescription forms for my meds since it had been a year since I saw him last, for months I have been experiencing dizzy spells, racing heart, headaches, but just thought my blood pressure problems were getting worse, maybe I was eating too much salt etc. but now that I think back on things, knowing what I know now it was not anything that I was doing it was the medicine! I am pulling all of my prescriptions out of Rite Aid! Never really liked the way my doctor handles things so I will also be looking for a new primary physician!

    Reply
  40. Tom Lamb Avatar
    Tom Lamb

    Cathy:
    Lately, I have been staying out of the way, so to speak, and letting patients share directly with each other their respective experiences by use of this Comment section.
    However, I do want to thank you, and others like T. McManus (who submitted a Comment, here, just before you), who have taken the time to communicate what you have been through. I have no doubt it is appreciated by the many others who have been reading these posts, as it provides another perspective on these Metoprolol recalls by Sandoz and ETHEX.
    Have a good week, all.
    Tom Lamb

    Reply
  41. Paul Avatar
    Paul

    I was doing some research to find out why my Toprol XL 25mg has been on back order when I found this site/article. It set me back in my chair.
    I had ‘events’ Dec/Jan. ’07 of extreme loss of balance / disorientation and other effects. I told my doctor that the events coincided with a change in how my pill looked and reading the label confirmed a change in the mfg. Guess who the mfg was…
    The doc put me on the name brand and no problems since.
    I always had a strong suspicion it could have been the change in medication mfg. and this strengthens that suspicion.

    Reply
  42. Linda Avatar
    Linda

    I am grateful for this blog on Metroprolol Er Succinate. I was put on a 25 MG in Dec. 09 by my Doctor. I have had nights where I have awakened with a chest burning pain that is a little left of my sternum. I have never had an angina pain before and was worried that it might be angina. Now I think that it may be an effect of the Metoprolol that I have been taking. I have never had such a symptom before taking the Metropolol. I awoke at 4:30 AM with the pain and came out to research the effects of the pill and found this site. A week ago, I went to get my second refill of Metropolo at Walgreens and was told that the generic Metoprolol ER Succinate was no longer available, so the prescription was refilled with Toprol XL. I will talk with my doctor today about the recall. I am surprised that the doctors office was not in the loop about this recall and contact all their patients who were on it. I have been still taking the Metoprolol as I had a few pills left. This whole thing makes me very wary of generic drugs.

    Reply
  43. Susan Z Avatar
    Susan Z

    Hi Tom,
    In Dec 2008 I was diagnosed with hyperthyroidism. Due to the hyperthyroidism I developed tachycardia. I have never had a problem with breathing or my heart. On Jan 2, 2009 my doctor put me on Metoprolol ER (Sandoz)for the tachycardia. Instead of slowing my heart rate, my heart rate increased, trouble breathing, chest pain, numbness in legs,feet, hands. Dizziness, headaches, nausea, hair coming out, swelling and a feeling of being “out of body” and lots of anxiety. On Jan 15, 2009 my heart went nuts, sweating, pain. On Jan 16th I was diagnosed with a partial bundle branch block. I am going to see a cardiologist on Tuesday to see if a pacemaker is needed. I was always in great health, 5’8 130lbs, physically fit and now I have a problem with my heart and can’t even walk up a flight of stairs. I am now on Atenolol. I complained for 2 weeks to my doc that the Metoprolol was making me feel horrible and until the EKG he insisted I stay on the drug. He seemed to freak out a bit with the EKG and told me to bring in the script with remaining pills for him to see. He has not given it back to me. I heard from my pharmacist that he perscribed the drug more than any other doc in the area. I always see drug sales reps in in office and I am wondering if he knew about the recall and just kept perscribing it? My pharmacist did not get the recall until Feb 13th. With all the technology we have nowdays why did this happen and does it continue to happen? I had an EKG a year ago before having a breast biopsy and there was no block and now I have all these problems when I took the Metoprolol. Is there anything else I need to know before I see the cardiologist and should I get my script back from my doctor?
    Thank you
    Susan Z

    Reply
  44. sharon pennington Avatar
    sharon pennington

    Hi my name is Sharon and I am shocked by this recall – I have been taking this generic since it came out – and I take 100mg a day – I am not sure which refill it started to occur with but it was summer and I had constant eye problems – I suffered for 2 months with crusty dry red stinging eyes – chest pains, high blood pressure, numb hands and feet and a cold feeling that would not go away – I would not be able to stay awake past 8pm – unusual for me – but I felt drugged and out of sorts – I was getting headaches constantly and feeling out of my body – like I was drugged or something – I just last week called in to get a refill on my medicine and received a letter from Future Scripts that said that my med was “on backorder or that there was a shortage” and that they were subbing the tar 50 mg to be taken 2xs a day – no where in this letter is a mention that there was a recall and until I went on line today I WAS STILL TAKING THIS MEDICINE!!!!!!!!!!! I CANNOT BELIEVE THERE IS A RECALL AND I AM NOT MADE AWARE OF IT – I am going in the hospital in two weeks for anesthesia and am scared out of my mind now – I think back now to when I got the last refill and I told my boyfriend one day I was taking one of my meds and it looked different – but I took it anyhow – I figured it was issued from the pharmacy so it is ok to take – I am mad and upset and think this is so wrong – what can we do about it

    Reply
  45. trpl777s@yahoo.com Avatar
    trpl777s@yahoo.com

    I was researching metoprolol on the internet when I came across this. I am taking 200 mlgs of one of the ones on the recall list. The reason I was researching was because I developed pustular plantar psoriasis in Nov 2007. My derm said sometimes a beta blocker could cause this. I was on Toprol XL with no problems and then when I received the generic I got psoriasis. Very severely and I am now disabled from it. I really believe now this was the cause. I made a doctors appointment to come off the Metoprolol Succ. This infuriates me that if my Psoriasis was caused from this.

    Reply
  46. jean Avatar
    jean

    My husband has taken toprol for years and then switched to the generic metoprolol. Over the past few months he has suffered from severe itching and rash on his leg that will not go away. He has been to doctors and dermatologists. No one seems to know the cause. Now after attempting to fill his prescription for metoprolol and finding out about the recall today (2/24/09) we have begun doing some research. It seems that rash and itching could definitely by a side effect. Luckily he hasn’t experienced the heart palpitations or dizziness others have. I find this appalling that neither the pharmacy or his heart doctors have notified him regarding the possible side effects of the recalled drug. He plans on making some visits and phone calls tomorrow. Have any of you experienced the itching or rashes? I am so thankful for others who submit their symptoms and concerns. We can all learn so much from each other – keeping those we put our trust in honest!

    Reply
  47. Frances Avatar
    Frances

    I just went to pick a refill on my metoprolol 50 mg ER and was shocked when told the price, so asked why and was told it was not the generic anymore, they had been recalled. K-Mart told me they didn’t have to call customers about the recall because it was voluntary – so I came home to get the internet for info & found all of this. I am so mad! I was hospitalized in May of last year for facial numbness, an unexplained anxious feeling, thought I was having a stroke, ended up having to see a neurologist. Plus, have been having rashes & itching, redness & heat in my knees. Now I am wondering if it is all caused by this generic!! I refilled my generic in November – no one said anything!!!! This is so maddening. Seriously, peanut butter gets recalled & everyone gets told, but a prescription drug has problems & no one speaks up! I am going to start the real Toprol immediately!

    Reply
  48. Stan A. Williams Avatar
    Stan A. Williams

    I have had almost identical symptoms, wanting to claw my eyes out of my head, unable to open them in any kind of light, blood pressure high at alarming levels, unable to stay awake at all; if I sit still for five minutes, I’m asleep. Horrible headaches, turning frequently into migraines which require further severe meds which in turn raise blood pressure further. And they just refilled mine two weeks ago. Class action suit anyone?

    Reply
  49. Renee Avatar
    Renee

    I am sitting here reading this in tears!!! I was put on metoprolol in January because my blood pressure was alleviated. Since being on the meds I thought I was going out of my mind! I was always cold, to the point that mny toes were purple, I had severe itching, my vision was whacked, my head had weird sensations…now after reading all this…I believe it was the metoprolol!!! This isnt right! Why didnt someone make us aware of this!! You can bet if there is a lawsuit filed I want to be a part of it!

    Reply
  50. Cathy Avatar
    Cathy

    I wrote down below under trpl777s. I just wanted to update. I have been off the metoprolol for 6 days. The rashes on my arms and legs are gone. My chest and neck used to be beet red and itch. It is now pink and doesn’t itch. My eyes are not dry and not hurting to the light. My hands and feet are not turning purple. My pustular psoriasis hasn’t lessoned though. There is no doubt now that the medication was causing these problems. The FDA should really be looking into this.

    Reply
  51. Angela Avatar
    Angela

    I can NOT believe this junk, I am 31yrs old and pregnant with #3, I have been taking this med for over a year, and here I am 5 months pregnant wondering why I can’t get the generic of Toprop xl anymore!
    I have had very bad headaches, cold feet, dizzy, stomach pain, along with a couple other symptoms and I thought it was due to my pregnancy…THE MAKERS OF METAPROLOL SHOULD PAY, and if this has caused something to be wrong with my unborn child I am going to find these people and kick some butt!!!THEY SHOULD BE TELLING EVERYONE, WE SCREWED UP!!!

    Reply
  52. Debbie with a D Avatar
    Debbie with a D

    I am not sure who Tom is? I have been reading all the comments above as I off of work today trying to find another brand.. Here is my story with this med. I was put on it over a year ago for elevated heart rate common in my family. I am fit all vitals are fine, good cholestrol etc… At first I felt better, I had been taking the 25mg once per day. After awhile that was not working and was told by my Dr. to take 2x day. Over the year I had to had noticed the size change and asked it this was my medication? They said yes mfg . Ok….I am not really sure when changeI started to feel worse. No energy, too much engery, headaches that were different then my regular ones. Anxious, agitated,out of breath, and yes the blurriness of eyes. I would wake up out of dead sleep with a HR of at least 110 and feel exhausted after a nights sleep. One of my last refills were on Dec 31! One day before the actuall recall. Still continued to not feel well, thinking damn it has a been along winter, stress ect…Before vaction I call in my refill and on the way to the airport, opps sorry we are out. No expanation! I specially said I have a few left I can take and they said they would call my Dr and get a different script and I could pick it up anywhere in the US. So on vaction I was feeling worse. I finally has to get the refill that is when I first heard of the recall that was February 11! My Doctor did not know I was getting the generic. The pharmasist in FL was helpful and informaitve and in days I felt better this verison was tiny in size in comparison what I was taking. Present day…Refill at home smaller non generic! I thought ok I will try, it not the generic but it still is Sanoz. Again I am back to feeling like sh**! I wanted the brand I had gotten in FL but no Wallgreens can get it in this midwest region. I was so angry, I complained to the pharmasist in charge. I had TOLD them I some left and at no point was I told to stop! I do not beleive the new and improved is new and improved or even worse I have been harmed by this medication. Then I thought of the elderly who don’t complain, that may still have some of this defective medication! WHY WERE PATIENTS NT NOTIFIED BY THESE PHARMACIES? So today I have called around for a different manufacture. By the way it is not good to go cold turkey off a Beta Blocker as your heart rate could elevate quickly. So I will once again try with a new phamacy a different mfg. and hopefully taper off. Again I hope I have not been harmed by this drug and it makers.

    Reply
  53. Jim Avatar
    Jim

    WOW… I thought I was just going crazy, I have suffered constantly running/crusting eyes, being very cold, rashes and itching, out of the blue rapid/offbeat heart rates and suddenly I get winded just walking up a flight of stairs. I have been on Metoprolol ER since June 2008, 37mg a day (one and a half 25mg tabs) the manufacter was Sandol until about November 2008 when I was changed to Ethex brand. I inquired about it at Walgreens (Illinois store) and they just said it was a common manufacter change. January 2009 I called in my prescription and they tell me they have to contact my doctor because they are all out of Metoprolol, two days pass and Walgreens calls back and says my doctor approved a new prescription. I go to Walgreens and they give me Metoprolol Tartrate(Mylan brand), I told them this is not what I take and they said the doctor approved it in place of the Metoprolol so I have been on this stuff since then. I hate taking any kind of drug PERIOD, I dont care how safe it is or how many people take it. Now I see I am not alone with these symptoms and now I have a reason for these symptoms. It seems like the FDA really dont care and neither does Sandol….I wonder how much Sandol contributed to political campaigns, maybe quality control would be a better place to spend the money.

    Reply
  54. Paulette Avatar
    Paulette

    Paulette
    I have been on the Metoprolol Er Succinate medication for awhile now and could not figure out why I had so much skin irritations and runney eyes. I have permanent scars now from all the scratching. I have been going to a dermatologist for over 2 years and nothing has worked.
    I have even been precribed medication for depression and a cream based steroid for the itching, nothing has worked.
    I hope there is a class action law suit.

    Reply
  55. dotty Avatar
    dotty

    I have had problems with some itching of legs, dry eyes, rapid heart rate, red and beefy color of my hands. My skin is dry and cracked on the bottom of my legs at times. I was never told about this drug and I have been on it for about 4 years. All of these problems started after I started taking this drug, but not knowing about any problems with the drug I did not associtate it with these symptoms. The last refill I got was about four months ago. When I went to get my refill a week ago, I was given Tropol and told Metoprolol was not available, but was not told why. I think we need to seek legal resolve and also what is the potential harm this drug have caused.

    Reply
  56. JoAnn Schnrider Avatar
    JoAnn Schnrider

    I am still fighting the afects of Metoprolol.
    After weeks of rapid heart beats I am trapped in :Flight or Flight; . Panic attacts and more problems than I care to write. An now on anti anxiety meds that will evenually help. I hope

    Reply
  57. Anita M Avatar
    Anita M

    My mail-in pharmacy switched my Metoprolol presctiption to the Sandoz brand in May 2008. I irritatingly called it my placebo. It seemed to work or not work. I had no idea there was a recall until yesterday. I decided to research on line, as my current generic seems to work just exactly as erratic as the Sandoz brand did. Unfortunately, I had a kidney infarct last year – a little over a month after taking the Sandoz brand generic. Right now I am just very angry. Health insurance for retirement was outragously expensive. Our prescription drug coverage wanted to supply the cheapest available (which is fine if it works), and no one tells me that I was or am endangered due to bad or possibly bad drugs.

    Reply
  58. tasha Avatar
    tasha

    I was on the er metoprolol er for years here recently i have been very tired short of breath ,eye water, raceing heartbeat, and now my dr. did a ekg and said something was abnormal i just had an ekg not even a year ago what could have happened? any way now the dr want to put me onmetoprolol tartrate 50 I am a little worried but want to know if anyone has taken this and how it makes them feel?

    Reply
  59. Anonymous Avatar
    Anonymous

    Having worked at Sandoz myself, I would NEVER take one of their generic drugs nor would I recommend their products to anyone I care about.

    Reply
  60. Tom Lamb Avatar
    Tom Lamb

    Anonymous:
    Thanks for sharing your insight / opinion. Not much I can add to that very clear statement.
    I hope you continue to read Drug Injury Watch.
    Tom Lamb

    Reply
  61. Jen Avatar
    Jen

    My husband had the same problem. I had to call the medics and we went to the ER 6 times. The medics thought he was having another heart attack, but the ER found he had not had another heart attack.

    Reply

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