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Old 01-21-2008, 09:22 PM   #1
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Generic drugs & brand name drugs

Just read an informative article about the safety of generic drugs. Here's what I learned:

1.) The FDA requires generics to contain the same active ingredient as the brand name but the fillers (other stuff in the pill or capsule) can be different.

2.) The People's Pharmacy has heard from hundred's of patients about bad expereinces with certain generic drugs.

3.) Consumer Labs conducted tests on Wellbutrin generics. One generic had the active ingredient but instead of releasing the drug slowly, it dumped 34 % of the drug into the blood stream within four hrs, it had put 1/2 the drug into the body instead of 1/4 of drug as it was supposed to. This could be dangerous depending on the drug as well as ineffective in the long run. I've always been lerry of the time release drugs for this very reason.

4.) With some drugs like Synthroid for the Thyroid, a generic may work but it is very important to stay with the same manufacturer. The problem is that pharmacies usually buy from the cheapest manufactuer so the patient gets switched from one generic to another. Rite Aid in my town will order drugs from a particular drug manufacturer but the other pharmacies won't.

5.) Ask if the drug you are taking has a narrow therapeutic index. Synthroid is a example of this because just a little more can cause serious side effects whereas a few less mcg's can cause undertreatment. That's why Dr's must go slowly in finding the right amount of the drug.

6.) Keep a record of the effectiveness of the drug for the Dr. Taking one's b/p is essential for hypertensives.

7.) Always ask for the name of the drug manufacturer so you can keep track of which drug works the best.

8. If the once a day pill or capsule isn't working, try switching to the twice or three times a day.

9.) Report any problems to the FDA or the people's pharmacy ( a consumer group run by a pharmacist & his wife).

10.) The FDA only tested 50-60 drugs in 06' even thoug more than 3.3 billion drugs were sold.

11.) Drug manufacturing plants are supposed to be inspected every two yrs but it is usually every 3-4 yrs.

12.) The FDA doesn't usually have authority to inspect overseas plants even though 80% of ingredients for drugs are from overseas. Guess where my HCTZ comes from: China. I've been told before that their drug plants are inspected.

13.) Last, but not least is the fact that generic drugs are only required to test their drugs on 24-36 people for a short time. To top it off, the main ingredient isn't required to be in exactly the same amount.

More reason to take the least amount of drugs possible. Fam

 
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Old 01-21-2008, 09:23 PM   #2
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Re: Generic drugs & brand name drugs

That article was in 02/08 Prevention which has other great articles on other health subjects. Fam

 
Old 01-21-2008, 09:48 PM   #3
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Re: Generic drugs & brand name drugs

Hi,

Quote:
One generic had the active ingredient but instead of releasing the drug slowly, it dumped 34 % of the drug into the blood stream within four hrs, it had put 1/2 the drug into the body instead of 1/4 of drug as it was supposed to. This could be dangerous
No kidding! This could be dangerous with any drug but even more so with one that works on the heart. How scary. That's exactly what I've been afraid of. The effects of the drug wear off way before they should...could get really dangerous...thus the withdrawal symptoms. Makes sense to me.

Quote:
Ask if the drug you are taking has a narrow therapeutic index
I don't know anything about the therapeutic index and how it works so will have to find out more about it. Thanks for posting this, Fam

Quote:
13.) Last, but not least is the fact that generic drugs are only required to test their drugs on 24-36 people for a short time. To top it off, the main ingredient isn't required to be in exactly the same amount.
That is downright scary!!!! I'll have to find out how the generic drugs are regulated here. I haven't done it yet. Great post!

flowergirl

 
Old 01-22-2008, 08:38 AM   #4
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Re: Generic drugs & brand name drugs

Quote:
Originally Posted by famnd View Post
Just read an informative article about the safety of generic drugs. Here's what I learned:

...narrow therapeutic index.....
Is there an actual index? or is that a general description? Can you explain a bit more, please?

Quote:
...13.) Last, but not least is the fact that generic drugs are only required to test their drugs on 24-36 people for a short time. To top it off, the main ingredient isn't required to be in exactly the same amount....
Do keep in mind that the name brand name has already been tested (for what that's worth,) but of course that doesn't mean that the generic combo won't cause problems due to fillers and other inactive ingredients.

Famnd, are your sure the main ingredient isn't required to be in exactly the same amount? This doesn't seem quite right.

Quote:
...More reason to take the least amount of drugs possible. Fam
Yes, indeedy! Thanks so much for sharing this info, famnd. It was very helpful!

Bethsheba

 
Old 01-22-2008, 11:14 AM   #5
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Re: Generic drugs & brand name drugs

WOW - thank you Fam,

This confirms what I thought (I will get a copy of that article for my Dr. and myself!!!) -- as all my problems coinicided with taking a generic form of Toporol. I don't feel SO crazy anymore!!!

THANK YOU !!!!

 
Old 01-22-2008, 09:41 PM   #6
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Re: Generic drugs & brand name drugs

Beth & FG,

Since we have to put information that we read into our own words, I don't know how else to phrase what the article said about the amount of active ingredient in a generic drug. It didn't say it had to be the exact amount.

This article was written by Joe & teresa Graedon who are Prevention drug advisors. He has a PHD & she has a MS.

The FDA should be contacted to confirm that this is true.

Narrow therapeutic range means the amount of drug to do the job is very small. If you give too much of the drug, the patient will get sick from a overdose. If you give too little, his health problem won't be helped. For example, if a drug dose is 2 mg & the range that can be given is 1-3mg then there wouldn't be much leeway for error. Lebetalol has a wide range from 100mg-2400mg so there is less chance of error.

Prevention has a list of drugs which have a narrow therapeutic range. Fam

 
Old 01-23-2008, 12:47 AM   #7
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Re: Generic drugs & brand name drugs

Thanks for the information, Fam.

I talked to my coworker about my recent experience with the generic calcium channel blocker. She has cancer and thyroid problems and is on medication herself. She knows somebody firsthand who experienced a similar reaction to mine - frequently feeling ill after being switched to a generic drug. I refused the contact information offered as I saw no point in having a discussion about my experience with this person. It sure feels good knowing I am not the only one having difficulties with a generic version of a drug, as the pharmacist claimed. I belive that an adverse reaction to a generic drug is not as rare an occurence as some might think.

 
Old 01-23-2008, 08:37 AM   #8
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Re: Generic drugs & brand name drugs

Quote:
Originally Posted by famnd View Post
Beth & FG,

Since we have to put information that we read into our own words, I don't know how else to phrase what the article said about the amount of active ingredient in a generic drug. It didn't say it had to be the exact amount.
Thanks famnd...I've done a little checking and it seems there is more info out there and that more people are questioning the safety of generic meds. Will do some reading on this and will start at the library for the article you mention...and will check for that PDR that you mentioned in a previous post...so sorry, I didn't thank you for that info but I did make a mental note to check it out at the library or bookstore.

Quote:
..This article was written by Joe & teresa Graedon who are Prevention drug advisors. He has a PHD & she has a MS.
These two are on public radio and I enjoy listening to them very much. They discuss non traditional therapies, traditional therapies, old wives tales, you name it! and answer people's questions. I found the info they have shared to be interesting and helpful!

Quote:
The FDA should be contacted to confirm that this is true.
I think more info would be on their website, which is a .gov website so can be mentioned here.

Quote:
...Narrow therapeutic range means the amount of drug to do the job is very small. If you give too much of the drug, the patient will get sick from a overdose. If you give too little, his health problem won't be helped. For example, if a drug dose is 2 mg & the range that can be given is 1-3mg then there wouldn't be much leeway for error. Lebetalol has a wide range from 100mg-2400mg so there is less chance of error.

Prevention has a list of drugs which have a narrow therapeutic range. Fam
Thanks for the clarification here...will check out the info. This is another example of why it is so important not to adjust your dosages unless it is under a doctor's/pharmacists supervison.

Bethsheba

 
Old 01-23-2008, 08:40 AM   #9
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Re: Generic drugs & brand name drugs

Quote:
Originally Posted by flowergirl2day View Post
... I belive that an adverse reaction to a generic drug is not as rare an occurence as some might think.
I would agree with you wholeheartedly, flowergirl. Like the side effects of brand name drugs, I suspect the side effects of generic drugs are not identified, and/or are underreported.

Bethsheba

Last edited by bethsheba; 01-23-2008 at 09:07 AM.

 
Old 01-24-2008, 06:18 AM   #10
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Re: Generic drugs & brand name drugs

Thanks, guys, for bringing up the topic and for discussing possible reasons for what I, too, believe to be the case. I don't take blood pressure meds, but I do take generic Ritalin. If I forget to say otherwise when I turn in my prescription, my pharmacy (here in Germany) orders for me whatever brand looks the cheapest at the time. I've gotten drugs from two different manufacturers, both of which say that the active ingredient is Methylphenidathydrochlorid. The pharmacist says that they are both the same and that I couldn't possibly notice any difference, because they both have the same working ingredient.

I can attest to the fact that they are very different! One brand acts just like name-brand Ritalin (calming both my mind and body), and the other acts like a psychoactive drug with very little calming activity (is that an oxymoron? ). With the drug from the second manufacturer, I feel that it stays in my system longer, I have less ability to concentrate, I have a short temper, and I often have weird dreams that would be perfect for the story lines in horror films.

The only difference that I can see in the listing of the filler ingredients is that the "good" brand has Lactose-Monohydrat (I am not lactose intolerant thank goodness), and the "less-good" one doesn't. But there must be some other factor that affects the delivery system. These two different brand names affect me so differently that as far as I am concerned, they are two different drugs.

I will definitely make sure I have an old package with me next time I go to fill another prescription, in about a month or two.

So, just to let you know that I quite agree that it isn't only the "active" ingredient that affects how a generic drug works. In spite of what the pharmacist believes!

--Rheanna

 
Old 01-24-2008, 03:14 PM   #11
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Re: Generic drugs & brand name drugs

Hello,

thanks for sharing your experience, Rheanna! We are not just imagining our symptoms and reactions to the medication as they would have us believe! My doctor seemed to believe me rightaway when hearing about the frequent chest pain and switched me (happily) back to Norvasc on a trial basis. I do not anticipate any problems with this medication as there were none during the time I used it briefly in the past. I'll monitor my heart rate and blood pressure closely because they have been elevated lately.
I still haven't had a chance to inquire about the government regulations in testing, approving, manufacture and distribution of the generic drugs in this country. There must be a guarantee of active ingredients in generic drugs just as there is in domestic pesticides. The manufacturers are required by law to list guranteed active ingredients on the pesticide labels.

flowergirl

 
Old 01-24-2008, 05:48 PM   #12
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Re: Generic drugs & brand name drugs

I am so happy for you Flower - that he listened to you!!

I hope the Norvasc works WELL!! Why did they take you off before - if you don't mind me asking.

Also, what types of ingredients in the generics should I be looking for that I could be reacting to?

Thanks

 
Old 01-24-2008, 06:08 PM   #13
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Re: Generic drugs & brand name drugs

Hi Vanessa,

My specialist prescribed Norvasc originally and I took it for a while. My GP felt the Felodipine would be better suited for cardiological purposes and had me take that. Now I am back on Norvasc and feeling no tighteness in the chest, tugging or pulling on the heart. I think I can feel the difference already. My heart rate has decreased after taking my first dose of this medication. My head feels better so I know the BP is down from what it was before (151/98).

I don't have an answer to your second question though I will try to find out, if only to make sure the pharmacist was RIGHT. If he wasn't, he will be hearing about it!!!!
I am glad about being switched back to Norvasc but mad about other things and will look for a new doctor. I have some issues that have to be dealt with and cannot continue to be ignored as has been the case.

flowergirl

 
Old 01-29-2008, 02:24 PM   #14
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Re: Generic drugs & brand name drugs

Hi Famnd,

I agree 100% that generics are not the same pill as the Brand name. How can a generic pill which is not tested and does not have to perform to the same standards as the Brand pill in research studies be equivalent??
Recently I was prescribed a pill (a generic equivalent) and when I researched the Manufacturer (located in N.J.) I was surprised to see the warnings the manufacturing plant was cited for. Among them were:

FDA Reported:

<http://www.fda.gov/foi/warning_letters/g6235d.htm>

P.S. Do I still want to re-fill my prescription??

Last edited by mod-anon; 01-30-2008 at 12:02 AM. Reason: Do not copy material directly from another website.

 
Old 01-29-2008, 04:48 PM   #15
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Re: Generic drugs & brand name drugs

What an eye opener!

Thanks for digging this up and sharing. I read an article about therapeutic equivalence of generic drugs. There are many loopholes in existence allowing these companies to manufacture and distribute a product deemed therapeutically equivalent to a name-brand in spite of a lesser degree of efficacy and safety.
An opinion was expressed that perhaps the increase in symptoms may be reported because after the switch from a name-brand drug to a generic one more attention is paid to the symptoms. Though it may be true in a certain percentage of people it does not apply to everyone with a negative experience after the drug substitution. I don't buy it. Our concerns about the generic drugs' efficiency and safety are legitimate in my opinion.

flowergirl

 
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