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FDA Finds Fault with Generic Toprol XL which is Metoprolol Succinate ER
Some of you may know about this, but this information is very important. This is probably the most prescribed beta blocker on the market. I would contact my prescribing doctor immediately if you take this generic form - Metoprolol Succinate ER.
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Latest News: FDA Finds Fault with Generic Toprol XL -- Problems Reported Earlier by ConsumerLab.com
(Date Posted: 8/28/2008)
On August 12, 2008, the U.S. FDA sent a letter to Sandoz Inc. warning of violations in its manufacture of Metoprolol Succinate ER tablets and other drug products. Sandoz's Metoprolol Succinate ER tablets are generic versions of Toprol XL.
In March 2008, ConsumerLab.com reported on consumer complaints with Sandoz's Metoprolol Succinate ER. As described in the ConsumerLab.com report, consumers have experienced increased blood pressure, increased heart rate and ectopic beats, as well as side effects such as nausea, dizziness and headaches when switched from Toprol XL to Metoprolol Succinate ER. ConsumerLab.com noted that the Sandoz formulation of the product is different from Toprol XL and dissolves in a different manner.
In its letter to Sandoz, the FDA states that, based on an inspection of a North Carolina plant in March 2008, Sandoz failed to appropriately validate the manufacturing process for Metoprolol Succinate (25 and 50 mg). Some lots were found to fail tests for content uniformity or dissolution. The FDA noted that Sandoz's practices represented a "moving target of quality."
The FDA notes that Sandoz did not conduct timely investigations of lots that failed dissolution testing. In addition, Sandoz chose to continue to release product even after being notified of violations.
The FDA concluded that Sandoz does "not provide a high level of assurance" that its process is "capable of producing a product that meets specifications." The FDA added, "We question the continued distribution of this product until better process controls are implemented and process validation is completed." The FDA requires that Sandoz take prompt action to correct the violations.
http://www.consumerlab.com/recalls.asp
http://www.fda.gov/foi/warning_letters/s6891c.pdf
========================================================
Latest News: FDA Finds Fault with Generic Toprol XL -- Problems Reported Earlier by ConsumerLab.com
(Date Posted: 8/28/2008)
On August 12, 2008, the U.S. FDA sent a letter to Sandoz Inc. warning of violations in its manufacture of Metoprolol Succinate ER tablets and other drug products. Sandoz's Metoprolol Succinate ER tablets are generic versions of Toprol XL.
In March 2008, ConsumerLab.com reported on consumer complaints with Sandoz's Metoprolol Succinate ER. As described in the ConsumerLab.com report, consumers have experienced increased blood pressure, increased heart rate and ectopic beats, as well as side effects such as nausea, dizziness and headaches when switched from Toprol XL to Metoprolol Succinate ER. ConsumerLab.com noted that the Sandoz formulation of the product is different from Toprol XL and dissolves in a different manner.
In its letter to Sandoz, the FDA states that, based on an inspection of a North Carolina plant in March 2008, Sandoz failed to appropriately validate the manufacturing process for Metoprolol Succinate (25 and 50 mg). Some lots were found to fail tests for content uniformity or dissolution. The FDA noted that Sandoz's practices represented a "moving target of quality."
The FDA notes that Sandoz did not conduct timely investigations of lots that failed dissolution testing. In addition, Sandoz chose to continue to release product even after being notified of violations.
The FDA concluded that Sandoz does "not provide a high level of assurance" that its process is "capable of producing a product that meets specifications." The FDA added, "We question the continued distribution of this product until better process controls are implemented and process validation is completed." The FDA requires that Sandoz take prompt action to correct the violations.
http://www.consumerlab.com/recalls.asp
http://www.fda.gov/foi/warning_letters/s6891c.pdf
It is a shame and a tragedy that you and others had to go through this ordeal, especially without any support from people here, or anywhere probably.
I (maybe we?) that did not lend support, or comfort, find it so hard to believe that people with heart disease or conditions can be treated like this. Especially when "In March 2008, ConsumerLab.com reported on consumer complaints with Sandoz's Metoprolol Succinate ER.", and YOU had no idea of why you felt so bad.
So my excuse for lack of support is my monumental disbelief in the way the "system" handled this very serious screwup.
I do hope that all of you are better, and that there are no lasting affects from this bad medicine. Sandoz Inc. deserves being sued whether there are any long term affects, or not.
My best to all of you,
Jack
I (maybe we?) that did not lend support, or comfort, find it so hard to believe that people with heart disease or conditions can be treated like this. Especially when "In March 2008, ConsumerLab.com reported on consumer complaints with Sandoz's Metoprolol Succinate ER.", and YOU had no idea of why you felt so bad.
So my excuse for lack of support is my monumental disbelief in the way the "system" handled this very serious screwup.
I do hope that all of you are better, and that there are no lasting affects from this bad medicine. Sandoz Inc. deserves being sued whether there are any long term affects, or not.
My best to all of you,
Jack
Same problems here....I kept telling my cardio doc that it was making me worse (besides HBP I have SVT) and he wouldn't believe me! So I stopped taking it on my own...this was quite some time ago.
Stupid doc.
Stupid doc.
I had the same problems with metoprolol. I thought I was dying for 3 months. The doctor wouldn't even answer me when I asked if the metoprolol could be making me feel so bad. I finally started to wean myself off of this drug and I am starting to feel a little better, but I still have the side effects. I have been off this drug for 4 days.
If you look back in this Medhelp forum around March 2008, I was complaining about this same thing and no one would believe me! It almost did me in for 3 months. My medical bills were 6 inches thick and I had every test known to man. I can't believe they finally caught on. I filed a complaint with the FDA, you can do it on-line at their website. I highly recommend it, it does get their attention.
Do this article apply if you didn't switch over from the brand name? I was on the generic only but had many side effects that they mentioned...
I'd be only too happy to start a forum of people who'd actually like to persue going after the manufacturer , KV Pharmaceuticals, for not taking responsibility that their metoprolol succinate ER 50 MG is a dangerous drub. Please contact me on on my email: ***@****.
Robin Iver
Robin Iver
Its about time the FDA does something! I tryed generic toprol xl and had very bad
side effects and problems from it.. forced me to buy the non generic toprol xl for $$$
out of pocket !! due to Medco plan for meds. I think the FDA should check all the b.p
meds Generic and Non Generic for problems as well. and really check the big pharm companys outside the U.S.A . that send us some of these drugs !
I would be 9 out of 10 companys wouldnt meet the u.s. standerts !
im off toprol xl totaly now - and on a ccb - another generic form with tons of side effects!
all I can say its about time !!
side effects and problems from it.. forced me to buy the non generic toprol xl for $$$
out of pocket !! due to Medco plan for meds. I think the FDA should check all the b.p
meds Generic and Non Generic for problems as well. and really check the big pharm companys outside the U.S.A . that send us some of these drugs !
I would be 9 out of 10 companys wouldnt meet the u.s. standerts !
im off toprol xl totaly now - and on a ccb - another generic form with tons of side effects!
all I can say its about time !!
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