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Old 01-07-2010, 11:23 AM   #1
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"BYSTOLIC" opinions after 2 years of FDA Approval

My doctor prescribed Bystolic over 2 years ago after it's official release in the U.S. I switched beta blockers several times since. At present, I'm taking Bystolic 5mg again. Aside from fatigue, worse blood lipid/glucose results and some sexual problems in the beginning, most of the side effects have been rather mild. Have others been taking Bystolic for an extended period and what are your opinions and results so far??

 
Old 01-12-2010, 07:30 AM   #2
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BYSTOLIC fails to get FDA Approval for heart failure.

Forest Labs has tried to get Bystolic approved for heart failure patients. Last week the FDA refused to approve the blood-pressure drug for treating heart failure patients. Anyone with heart failure should not be on this drug. Toprol and Carvedilol are the recommended beta blockers. Apparently in an 8-0 vote, the advisory panel members who advise the FDA on new drug approvals said they will not recommend approval of Bystolic. An official ruling by the FDA is expected by March 1, 2010.

 
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Old 01-12-2010, 09:39 AM   #3
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Re: BYSTOLIC fails to get FDA Approval for heart failure.

Quote:
Originally Posted by ACE28 View Post
... Last week the FDA refused to approve the blood-pressure drug for treating heart failure patients. ... Toprol and Carvedilol are the recommended beta blockers.
Thanks for posting this interesting info about Bystolic!

I have heart failure. In case my Cardiologist ever tries to force Carvedilol out of my tightly clasped hand, I now have the info that you posted to booster my insistence that I stay on Coreg FOREVER and EVER!

I've never taken Bystolic. The only Beta Blocker I have ever taken is Coreg (Carvedilol). From what I've read, Bystolic has never gone head to head against Coreg, so there are very limited comparison studies.

This latest ruling by the FDA against Bystolic is probably making for some very unhappy people down at Forest Labs.

Regards!
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CHF, A-fib, HBP, Insulin Resist & Asthma much better

⇒ I avoid common ordinary but unhealthy household items
⇒ Balanced, healthy diet
⇒ Exercise
⇒ I alter my Circadian Rhythm
⇒ I LOVE COREG!

 
Old 01-12-2010, 12:03 PM   #4
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Re: BYSTOLIC fails to get FDA Approval for heart failure.

The news is now public information. I'm sure Forest Labs was counting on the heart failure indication. Unfortunately, you cannot change the statistical numbers. They may have tried to fudge some of the numbers by constantly changing certain values, but the FDA advisory panel was not convinced or for that matter confused. That's not a good thing. I'm glad Coreg is still working great for you. At present, Coreg and Toprol continue to be the gold standard for heart failure with a proven track record and years of research studies.

Last edited by hb-mod; 01-12-2010 at 12:09 PM. Reason: Removed Quote of immediately preceeding post. Please use "Quick" Reply rather than "Quote" Reply. Thanks!

 
Old 01-12-2010, 02:20 PM   #5
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Re: BYSTOLIC fails to get FDA Approval for heart failure.

Quote:
Originally Posted by ACE28 View Post
... At present, Coreg and Toprol continue to be the gold standard for heart failure with a proven track record and years of research studies.
I have a lot more faith in the older medications, that have proven track records and have endured large scale and trusted clinical trials. Like Carvedilol and Digoxin. Those two medications have been tested numerous times, with provable, beneficial properties.

I have learned first hand why both Carvedilol and digoxin has been approved for, and are beneficial treatments for Heart Failure and why they have such solid reputations. Carvedilol doesn't just bring down the blood pressure, but also causes some very noticeable, favorable and expected health improvements, as documented over and over again many times.

In my opinion, Bystolic has a long way to go before I believe that it is anywhere near as beneficial as Carvedilol. But, then again, that merely is my non-professional opinion, for what it is worth!
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CHF, A-fib, HBP, Insulin Resist & Asthma much better

⇒ I avoid common ordinary but unhealthy household items
⇒ Balanced, healthy diet
⇒ Exercise
⇒ I alter my Circadian Rhythm
⇒ I LOVE COREG!

 
Old 01-12-2010, 03:34 PM   #6
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Re: BYSTOLIC fails to get FDA Approval for heart failure.

Quote:
Originally Posted by Machaon View Post
I have a lot more faith in the older medications, that have proven track records and have endured large scale and trusted clinical trials. Like Carvedilol and Digoxin. Those two medications have been tested numerous times, with provable, beneficial properties.
I agree, though most doctors would not agree. Unfortunately, they are to quick to start patients on the newest medications to "advance science" or for drug company perks. The problem is, a large number of newly approved drugs are extremely harmful, and the results can often be fatal. Bextra, Baychol and numerous others were proven to increase the risk of death. Bystolic may not be the best for heart failure, but it's definitely not in this category. It's licensed in 75 other countries and has been approved in Europe for close to 15 years. I believe in the U.K, it is approved for heart failure. For high blood pressure and heart rate control, it's still a pretty effective drug.

 
Old 01-13-2010, 08:49 AM   #7
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Re: BYSTOLIC fails to get FDA Approval for heart failure.

Quote:
Originally Posted by ACE28 View Post
I agree, though most doctors would not agree. Unfortunately, they are to quick to start patients on the newest medications to "advance science" or for drug company perks.
I agree with you. For the past 22+ years I have endured many different medications and combinations of medicines and had to suffer from many nasty interactions and side effects. I avoid new medications like the plague until they have been thoroughly tested.

That is some of the background for why I choose to stay with Creg (Carvedilol) Digoxin and Warfarin. Also.... when I was taking a tested, and proven Ace Inhibitor, I refused to switch to an ARB for the same reasons. Plus.... the newer medications are MUCH more expensive than the old generics. My health is important to me but so is my wallet!

Quote:
The problem is, a large number of newly approved drugs are extremely harmful, and the results can often be fatal. Bextra, Baychol and numerous others were proven to increase the risk of death.
Ze problems is that many patients think that their doctors are some sort of god, and that their doctors truly have the answers. NOT! Most doctors do not take enough time to research and fully evaluate each of their patients, and most doctors don't really have the incentive to put any more time into any one patient. As a result, doctors are merely experimenting, more or less, on patients with difficult to treat high blood pressure, heart rhythm problems or heart disease.

Quote:
Bystolic may not be the best for heart failure, but it's definitely not in this category. It's licensed in 75 other countries and has been approved in Europe for close to 15 years. I believe in the U.K, it is approved for heart failure. For high blood pressure and heart rate control, it's still a pretty effective drug.
From what I have read, the jury is still out on the overall effectiveness of Bystolic and it's side effects. It may be many years before sufficient tests are run using Bystolic, or comparing Bystolic with other Beta Blockers.

I'll stay with the proven and effective Carvedilol. At least I know fully what I am dealing with, and Carvedilol has treated me kinda nice. I love the stuff. OTOH, I am glad that Bystolic has been good for you! That is a great test of the medication, all in it's own.

Take care....... have a great day!
__________________
CHF, A-fib, HBP, Insulin Resist & Asthma much better

⇒ I avoid common ordinary but unhealthy household items
⇒ Balanced, healthy diet
⇒ Exercise
⇒ I alter my Circadian Rhythm
⇒ I LOVE COREG!

 
Old 01-13-2010, 05:59 PM   #8
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

Quote:
Originally Posted by harcle12 View Post
Thank you Ace! I've heard from a few people that I should cut the 5mg tab I'm taking now in half for the first week instead of the skip day program but when I mentioned it to my Dr he said no and to go with the program he laid out-every other day, etc. Hopefully it will be ok as i have a very healthy heart per echo ekg a 1 1/2 yrs ago and other tests. Plus I'm in pretty good shape so I hope it will be ok!
Thanks for you input! Jack

In this case, I would listen to my doctor. He is talking form experience and training. Besides, you are paying this doctor to monitor and treat your condition in the best way he sees fit. If not, why bother going to your doctor for advice. If you don't follow his recommendations and something should go wrong, it would be entirely your fault because you were given professional advice from an M.D, and you ignored him.

Note: This is just my opinion, the decison is ultimately yours.

Last edited by mod-anon; 01-14-2010 at 04:31 AM.

 
Old 01-13-2010, 06:06 PM   #9
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

I agree! Just wondered what to expect in the way of withdrawal symptoms.
thanks!

 
Old 01-14-2010, 07:19 AM   #10
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

That can't always be anticipated. Some have no side effects all and feel so much better than before. Some feel worse when also switching to another medication.

 
Old 01-14-2010, 11:24 AM   #11
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

Thanks again Ace! I'm going to follow the Dr's instructions and I am honestly not that concerned, just didn't know what to expect. Hopefully I will be able to get straight back to the gym once I stop completely, since the guidelines are nothing strenious while tapering down--wonder if that means no sex as well! Hope not! Also wonder if an occassional Jack Daniels would hurt--cant cut out everything can you? I really appreciate your feedback as you certainly seem to know what you are talking about.
Jack

 
Old 01-15-2010, 10:51 AM   #12
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

You may have to remain celibate for at least 2 years....and drink only prune juice.

Last edited by hb-mod; 01-15-2010 at 02:32 PM. Reason: Removed Quote of immediately preceding post. Please use "Quick" Reply rather than "Quote" Reply. Thanks!

 
Old 01-15-2010, 11:30 AM   #13
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

Ace--Thanks again. After reading the threads here and your feedback, I had another conversation with my doctor. He feels that due to my exercise program (pushing my H R up through cardio-treadmill, etc) that I would have no problem with the increased heart beat, etc. when stopping. However he was comfortable with me reducing my dosage in half (5mg down to 2.5mg)(as you mentioned in one of the threads) for a couple of weeks and then going to the skip a day then three day program. I feel much better about it and will post the progress as it happens for others to see. Got heart rate to 129 (good for being on a beta blocker) last night with BP post work out at 118/61. Feel good about this! Thanks a ton for your input! It's much appreciated!
Jack

 
Old 01-15-2010, 11:32 AM   #14
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Re: "BYSTOLIC" opinions after 2 years of FDA Approval

Older Marines like me can't drink prune juice and celibasy is out of the question! -

 
Old 08-10-2010, 03:11 PM   #15
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Re: BYSTOLIC fails to get FDA Approval for heart failure.

I have heart failure secondary to HBP and i am on Bystolic.
I am allergic to ace inhibitors, arbs, tekturna and absolutely couldn't tolerate Coreg. Should i tell my doctor? I have to take something cause my resting heart rate is 94.





Quote:
Originally Posted by ACE28 View Post
Forest Labs has tried to get Bystolic approved for heart failure patients. Last week the FDA refused to approve the blood-pressure drug for treating heart failure patients. Anyone with heart failure should not be on this drug. Toprol and Carvedilol are the recommended beta blockers. Apparently in an 8-0 vote, the advisory panel members who advise the FDA on new drug approvals said they will not recommend approval of Bystolic. An official ruling by the FDA is expected by March 1, 2010.

 
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