Some info on generic drugs

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Generic Drug Side Effects

http://www.suite101.com/content/generic-drugs-side-effects-a85344


Generic Drugs Side Effects
Generic Dangers the FDA and Drug Companies Don’t Talk About
Dec 19, 2008 Tricia Spencer

Generic Drugs - Andrzej TokarskiGeneric drugs save money, but at what cost to overall health? Are they effective? Yes. Are they identical to brand name drugs? No.

As stated at FDA.gov, “The FDA requires all generic drugs to have the same high quality, strength, purity and stability as brand-name drugs.” But they make no such requirement of a generic drug’s inactive ingredients.

There is little dispute that generic drugs utilize the same active ingredient as their brand-name counterparts or that you can expect a generic substitution to work within the human system in the same manner. But what is not expected is that the added FDA-approved fillers, dyes and agents can be whatever the generic drug company wishes to use.

Prinivil is an ace inhibitor primarily used to treat high blood pressure and congestive heart failure. The active ingredient in Prinivil, which is manufactured by Merck & Co., Inc., is Lisinopril. Lisinopril is what the drug bottle would say if your doctor wrote a prescription for generic Prinivil. Lisinopril is made by multiple drug manufacturers, and you would receive your prescription from the manufacturer who cut the best financial deal with your pharmacy. As the example below shows, each manufacturer is permitted to add inactive ingredients at will.

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Prinivil by Merck & Co., Inc. – Inactive Ingredients in a 20 mg dose:

calcium phosphate
mannitol
magnesium stearate
starch
iron oxide
Lisinopril by Mylan, Inc. – Inactive Ingredients in a 20 mg dose:

colloidal silicon dioxide
croscarmellose sodium
dibasic calcium phosphate
magnesium stearate
mannitol
povidone
pregelatinized starch
sodium lauryl sulfate
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In this comparison, the generic Lisinopril has nearly double the inactive ingredients as the brand-name Prinivil. Those additional ingredients may increase the risk for allergic response. Doctors and pharmacists rarely caution against potential adversities from inactive ingredients. The FDA requires no such labeling or warning. And yet people routinely have difficulty with a prescription without knowing why.

For example, sodium lauryl sulfate can cause adverse reaction in sensitive people. Sodium lauryl sulfate is a surfactant (soap) approved by the FDA for use in toothpastes, cosmetics, shampoos, lotions, ointments, creams, and drugs. It is a caustic detergent that can be used as an effective de-greaser. Its purported purpose in drugs is as a wetting and dispersing agent. But the question must be asked. If Merck’s Prinivil is effective without this ingredient, why does Mylan’s Lisinopril need it? The truth is that it does not need it, and with its inclusion, people sensitive to sodium lauryl sulfate may suffer avoidable difficulties. They may believe they cannot tolerate the drug when, in truth, it is not the drug but rather an inactive ingredient that is the culprit.

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Adverse drug reactions can be reported to the FDA, but even as the problems with inactive ingredients grows, the FDA has taken the following position on their website:

“Due to an overwhelming response, we are no longer accepting Inactive Ingredient related questions via [email protected]. We have been inundated with requests and do not have the resources to adequately respond to questions in a timely manner.”

The inundation of requests can no doubt be laid at the feet of the generic drug companies who routinely use unnecessary, potentially adverse, ingredients in their products with the blessing of the FDA.

The FDA, who is the last line of defense for the consumer, provides the following question and answer on their website regarding their Inactive Ingredients Database.

“3. What is the purpose of the Inactive Ingredients Database?

The Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products.”

As stated, the FDA’s inactive ingredient database is an “industry aid” not a consumer information guide. Finding information on inactive ingredients requires diligence and resourcefulness. Sometimes the only way to find out what inactive ingredients are present in a generic drug is to track down the manufacturer, who is often in a foreign country, and ask them directly. This information is not freely offered on many drug company websites, and asking for the information in writing may result in a denial.

The FDA’s definition of an inactive ingredient is:

“According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient.”

Some inactive ingredients are necessary for the formation and utilization of any drug. But if a drug is effective with only five inactive ingredients, the need for nine makes little sense. The term “inactive” is misleading on its face. In the drug context it means that the ingredient does nothing to affect the active ingredient. It does not mean that it does nothing to affect the patient.

A doctor who was interviewed for this article, but who requested anonymity, stated that he used to experience about 5% of his patients unable to take Lisinopril, but that over time that percentage has increased to about 30%. He was unaware of the many additional inactive ingredients the generic companies are utilizing and when told, he stated, “it makes sense now.”

Some people will have no recognizable issues with any inactive ingredient, but others will experience side effects that cannot directly be related to the active ingredient in the drug. For a select percentage of the population these adverse reactions can be life threatening. Knowing every ingredient of every product used is the first step to understanding and avoiding adverse reactions.

Until the FDA and pharmaceutical companies choose to be responsive to the consumer with regards to unnecessary inactive ingredients, they may not be counted on to act with every consumer’s best interest at heart. It is the consumer who must be diligent.

Those interested in generic drug side effects may also enjoy reading How to Survive Kidney Stones, How to Fight Obesity with Good Health and Rolfing Structural Integration is Not Massage.



Read more at Suite101: Generic Drugs Side Effects: Generic Dangers the FDA and Drug Companies Don’t Talk About http://www.suite101.com/content/generic-drugs-side-effects-a85344#ixzz16w52E9fk

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D&C Yellow No. 10 Aluminum Lake HT -- I don't want this in my Oxycodone! Synthetic dye is made from toxic waste from caol tar factories and aluminum is associated with Alzheimers disease. Just give me pure opiate please!
 
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Great information. Generics are often NOT exactly the same as brand name drugs.
 
Does the article give any mention to the likelihood of an adverse event from taking a generic versus brand name drug? They don't due to the extremely low incidence associated with the excipients. Seems like more of hit piece by brand manufacturer trade associations or some such nonsense.
 
panic_the_digital said:
Does the article give any mention to the likelihood of an adverse event from taking a generic versus brand name drug? They don't due to the extremely low incidence associated with the excipients. Seems like more of hit piece by brand manufacturer trade associations or some such nonsense.
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That did cross my mind. Hard to say about agenda. Sometimes people never know if their intolerance was because of the inactive ingredients in a drug.

I do know of people that have migraines and get relief from brand Topamax. The brand works great for them but the generic is junk. Many complain about their hair falling out from the generic along with other problems. Some say that, as bad as their migraines are, they would rather deal with them then to deal with the generic side effects. Most can't get insurance to pay for the brand name. Most can't pay cash.

I have tried to get the brand Topamax and no matter what I do, my insurance won't cover it. I don't want it anyway... they don't call it "stupamax" for nothing.

I have read here and there that the generics have a "plus or minus" leeway with the active ingredients and this could cause a problem during a taper if the manufacturer is changed. But the brands keep an exact amount of the actives. The pharmacists I've talked to say this is not true.
 
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There is a plus or minus leeway (I don't have the # at hand, but it can be significant). This applies to both dissolution and active agent. However, in your case your problems are likely from the excipients, since most generic manufacturers of topiramate wouldn't stray too far from the kinetics of something as touchy as an anti-seizure med.

So yeah, your pharmacist should know better. Have you talked to the pharmacist and doc about getting a prior authorization for medical necessity?
 
I agree with your first post PtD. Reading through this I felt this article is simply trying to persuade the reader one way rather than show the realistic aspects.

Some inactive ingredients are necessary for the formation and utilization of any drug. But if a drug is effective with only five inactive ingredients, the need for nine makes little sense.
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A tablet may require more inactive ingredients than a capsule...
 
One brand of generic Fent barely worked for me and always fell off days early.

Another brand stayed on, but when I got out of the shower I overdosed because it was so much stronger than the other patch.

These two patches were supposed to be "chemically identical". The two products were not identical.
 
I have experienced this problem with generic bupropion. I was on the branded version of bupropion (Zyban) for depression which worked really well, however a few months ago the pharmacy dispensed the generic version to me and almost immediately I noticed a return of my depressive symptoms.

At first I thought it was due to a spontaneous relapse, however after doing some reading I began to suspect it was due to the generic substitution, so the next time my medicine was being dispensed I requested that the pharmacist dispense the branded version. Luckily in the United Kingdom we do not pay for prescription drugs so I did not have to worry about cost and pharmacists are usually quite good at respecting a request for branded instead of generic or vice versa. Even if the pharmacist wants to be difficult all you have to do is get your doctor to prescribe the drug as the banded version and then they have to give it to you.

Anyway, after about a week I noticed a definite change in the way I was feeling and a week later I was back to my usual self. I am aware that there is no way to tell whether this was due to the placebo effect or whether it was indeed due to differences in the formulation of the two preparations, however I know that I will not allow the generic version be substituted for the branded version from now on.
 
panic_the_digital said:
There is a plus or minus leeway (I don't have the # at hand, but it can be significant). This applies to both dissolution and active agent. However, in your case your problems are likely from the excipients, since most generic manufacturers of topiramate wouldn't stray too far from the kinetics of something as touchy as an anti-seizure med.

So yeah, your pharmacist should know better. Have you talked to the pharmacist and doc about getting a prior authorization for medical necessity?
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Yes, I did. Insurance still wouldn't cover it.
 
Astavats said:
I agree with your first post PtD. Reading through this I felt this article is simply trying to persuade the reader one way rather than show the realistic aspects.



A tablet may require more inactive ingredients than a capsule...
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A capsule shouldn't have anything more than corn starch and the drug in it. I agree however, a tablet may require more inactives, but why make a tablet then?

300mg Gabapentin comes in small capsules. The 600mg comes in a huge nasty tasting pill that is hard to swallow. I never understood shit like this, than even 600mgs of a substance is not a large amount.
 
Chemical and pharmaceutical companies and the FDA; call me cynical - but somehow, some way, it has something to do with more profits.
 
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Sentience said:
One brand of generic Fent barely worked for me and always fell off days early.

Another brand stayed on, but when I got out of the shower I overdosed because it was so much stronger than the other patch.

These two patches were supposed to be "chemically identical". The two products were not identical.
Click to expand...

One reason that one may have been stronger out of the shower is that heat increases absorption of the drug. For the sake of harm reduction, please don't go putting on Fentanyl patches under heated blankets.

Also, a lot has been said about why have other ingredients, such as the tablet vs. capsule discussion. Drugs will have different pKa's that will mena that they will be better absorbed at different parts of the GI based on local pH. The extra ingredients are often used to get the drugs to their point of optimum absorption.
 
This page was last reviewed by Dr Greg Mulhauser, Friday, 17 September 2010.

The URL of this page is:
http://counsellingresource.com/medications/discount-drugs/generics.html


Dr Greg Mulhauser
Will You Be First? retweet Generic medications can usually be purchased for a fraction of the cost of their branded counterparts.

Article Contents



What is a Generic Drug?
Are There Any Differences Between Generics and Brand-Name Drugs?
The Bottom Line on Generic vs. Brand-Name Drugs
What is a Generic Drug?
The active ingredient of a 'generic' medication (for example, of 'generic Paxil', which is Paroxetine) is chemically identical to the active ingredient of the corresponding branded medication. Because generic medications are often much cheaper than their branded counterparts, very many people choose generics (whether buying discount medications online or in traditional retail outlets), and many insurance companies actually require that they be used.

According to the FDA's Office of Generic Drugs:

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Are There Any Differences Between Generics and Brand-Name Drugs?
However, it should be noted that current regulations permit a variation of approximately 20% either way in the bioavailability of the active ingredient. (The specifics of the permitted variation in bioavailability hinge on the FDA's technical definition of bioequivalence, which requires that there be no statistically significant difference in bioavailability. For the FDA's definition, see the agency's Guidance for Industry documentation, which among other things sets out guidance on confidence intervals for test-to-reference comparisons across different types of medications, as well as the FDA's Code of Federal Regulations 320 document on bioavailability and bioequivalence requirements. Also see this 1999 Food and Drug Law Institute overview of the Hatch-Waxman Act of 1984.) In one study (Borgheini 2003), a full 31% variation was found in the blood plasma levels of a particular medication after a patient switched from a branded to a generic product. (Why does this happen? It may be accounted for by differences in the manufacturing process yielding different particle sizes that are absorbed at different rates, as well as other factors.)

The Bottom Line on Generic vs. Brand-Name Drugs
This does NOT necessarily mean that purchasing generic medications in preference to branded counterparts is a bad idea -- in fact, in most cases it is probably still a very good idea! -- but this does mean that the issue is not quite as clear cut as it might otherwise seem.

In my view, provided medications are taken under the supervision of a qualified medical professional, there is very little advantage to buying branded medications if cheap generic drugs are available. The only difficulty, of course, is that it sometimes takes many decades before generics actually do become available. (See the separate page of background to the controversy about discount drugs.)

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From what I can read... it sounds like different drugs have different guidelines under the FDA's guidelines 8)

Possibly one could look up specific drugs for specific variations???

http://www.suite101.com/profile.cfm/triciaspencer -- I read about the writer of the article on my first post. I seriously don't think she is associated with a pharmaceutical company. I was supposed to get permission to post more than 50 words from that article... sorry bout that.

Anyways -- generics aren't the same as brand, IMHO. Unless you have the cash for brand, you have to buy what they give you. Target and Giant pharmacies price shop when they buy their inventory of drugs. They keep switching the makers of the generic that I buy, e.g. from Watson to BARR, one is stronger than the other. -----That's just the way it is.
 
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