Generic Drugs: Inactive Ingredients

[fwes]

It is with some hesitancy that I write on this topic. My purpose is to inform, not to alarm. The issues I shall discuss are real, but I expect have very small impact on the general community. Please take care not to imagine that everything I say applies to you personally. With these caveats I shall proceed, because these issues have come up twice in other posts and also for me personally. As is my custom I provide my references: 1) my own personal experience, 2) consultations with my personal physician and my druggist, 3) drugs.com drugs.com/inactive/.

From other posts:

1. Disturbing facts (recent) healthunlocked.com/parkinso...

… we are now into chasing after sinamet after finding mum deterioration due to, her drug being swapped unbeknown to us! Turns out been giving mum a generic replacement …

and Reply: …There should be no difference between Sinemet and generic…

2. Carbidopa/Levadopa generics: potency/quality (three years ago).

healthunlocked.com/parkinso...

…I personally have experienced taking Carbidopa/Levodopa generics for a few years and felt differences between manufacturers and between batches even by the same makers…

and excellent first Reply: …as far as PD is concerned, Cmax might be the maximum level of levodopa in the blood-stream following a dose. Then, ignoring a number of statistical details, they need to show that these values fall within 80-125% of the original…

My comment: The first reply seems to minimize the distinction between “should be” and “is”. The second reply reveals the alarming range of accepted chemical level of the drug in the bloodstream and indicates that there is no testing of functional distinction and of possible side effects of so-called “inactive ingredients”. I strongly recommend a careful reading of this second reply for those who desire more technical information.

My experience: After more than a year of a satisfactory balance between my medications and my PD symptoms, I suddenly went downhill significantly in a period of a week or two. At the advice of my primary care physician I questioned my pharmacist and discovered that the manufacturer of my generic carbidopa/levodopa had changed in my latest prescription. When I insisted that they return to my previous generic manufacturer, my PD symptoms returned to the previous levels in the first day after I changed back to the previous medications. I pursued this with my pharmacist, who shared the following facts without reference: 1) there are differences in the inactive ingredients in formulations of different generic manufacturers; 2) the inactive ingredients provided by the manufacturers are proprietary and usually undisclosed; 3) while the inactive ingredients are termed “inactive” they occasionally have active impacts on patients; 4) the manufacturer a generic drug may change the inactive ingredients on their own; 5) when they do this they usually disclose the fact of the change in the professional literature, but not to the public, and even then they rarely diclose the ingredients; 6) the inactive ingredients are each tested by the FDA to determine that the do not cause significant harm, but there is no required testing of the generic drug and its inactive ingredient formulation; 7) there is reason to be alarmed since some of the inactive ingredients are known to be active on some patients and indeed some can trigger significant allergies, e.g. peanut oil is accepted as undisclosed inactive ingredient.

From “drugs.com” drugs.com/inactive/

“Inactive ingredients are components of a drug product that do not increase or affect the therapeutic action of the active ingredient, which is usually the active drug. Inactive ingredients are added during the manufacturing process of pharmaceutical products such as tablets, capsules, suppositories, and injections. Inactive ingredients may also be referred to as inert ingredients or excipients, and generally have no pharmacological effect. Examples of inactive ingredients include binding materials (which may be excipients), dyes, preservatives, and flavoring agents. Agents that combine with active ingredients to facilitate drug transport in the body are also considered inactive. (My emphasis)

“The FDA approves inactive ingredients that are included in pharmaceutical products. However, not all inactive ingredients are always inactive. Alcohol is one example of an ingredient that may be active or inactive based on the specific formulation of the medication. Patients may have allergic reactions or other adverse effects to inactive ingredients. If a patient has a known allergic reaction to an inactive ingredient, they should check for the ingredient in new prescription or over-the-counter medications or check with their pharmacist. Examples of inactive ingredients that are have been reported to cause reactions in some patients include: sulfites, benzoates, aspartame, saccharin, oleic acid, benzyl alcohol, lactose, soya lecithin, propylene glycol, and sorbitan trioleate. Patients who have allergic or adverse reactions to certain inactive ingredients may be able to use products that are color- or preservative-free.”

There follows a list of several hundred approved inactive ingredients. Caveat emptor!

[laglag]

Fwes: Thanks for your detailed reply. Do you have any idea how to find out if any pharmacy has the brand I prefer? I called many pharmacies in the Indianapolis area & even one in Louisiana and all of them are on backorder.

[fwes in reply to laglag]

No I do not, Sorry

[park_bear in reply to laglag]

Here is a US discount pharmacy which lists manufacturers.

drugsdepot.com/store.php/dr...

[laglag in reply to park_bear]

Thanks!

[MBAnderson]

Thank you for this post. It's important information. The 2 posts you refer to that raised this issue are both fairly recent. Actually, there are many such posts.

[Kwinholt]

Fwes, you are so correct about the manufacturers. I’ve had several issues and researched a lot of them . The manufacturer of my generic cd/ld that is best for me is the SUN manufacturer. It has an ingredient in it that makes it more water soluble reacts faster in my body , which after research other manufacturers don’t have in there’s. I had trouble getting it , and went to several pharmacies and found this wonderful pharmacist that try’s every month to order from there and has a stock pile for me on his shelf. He expressed that’s his job to help people with that bc some people have reactions from certain additives. I actually had another pharmacist that wouldn’t accommodate me say, “ Well honey, have you gave it thought that your disease is just progressing and the meds just aren’t working as good and has nothing to do with the manufacturer?”. I almost came a cross the counter a pulled her down by her ponytail. We know our bodies better then anyone . K

[Fishaholic in reply to Kwinholt]

I would of jumped over the counter. I had a problem with a pharmacist that kept changing my cd/ld meds. I went to pick up my medicine one day,there was 4 different generic in my script. He said they’re all where the same. I asked him if I switched is coffee he would know the difference.Not all generic are the same,I have been on this trip 13 years.

[Kwinholt in reply to Fishaholic]

Absolutely . I did have a few words with her and asked her when’s the last time she ran a marathon with Parkinson’s ? 😊 Don’t tell me they are ALL the same. K

[Hidden]

I changed from Stalevo to one of its two generic forms Sastravi. I did this to reduce the monthly cost to the NHS of about £70 for Stalevo and about £35 for Sastravi (although, of course, no cost to me for either). There was no difference in the effect of either variant of the drug for me.

I do wonder how many people worry about these sort of changes in formulations of medication and, given the effects of stress on Parkinson’s symptoms, develop negative symptoms. It would also be interesting to look at the types of “negative effect” and the incidence of anaphylaxis.

[park_bear in reply to Hidden]

According to the various comments that have been made on the subject, people do not even think about it until the medication suddenly stops working and it turns out it came from a different manufacturer.

[jujulini in reply to park_bear]

Everyone should make sure that the pharmacy knows that you only want a certain manufacturer. Sometimes mine is out of stock and has to be reordered. I wait for it rather than go with a different manufacturer. I have extras lefftover so i will not run out while waiting.

[Hidden in reply to park_bear]

I have followed many threads on generic medications and changes of manufacturers. Often the concern begins with the different packaging or the shape/colour of the medication.

[Johnboy46 in reply to park_bear]

Quite right.I was changed to a German "generic " in November last year, I noticed my tremor was worse a few days after,that was when I noticed the meds. were different. I have since managed to get back on Sinemet and my tremor has lessened. Whilst on the "generic " my sense of smell disappeared and my balance got worse. Progression of PD or lack of meds ? Neither has improved since being back on Sinemet !!!!

[jujulini in reply to Hidden]

It is insulting to suggest that it is “all in your mind” if someone experiences a negative effect from a different generic. If manufacturers can use different inactive ingredients then of course it is possible to react negatively to them.

[Hidden in reply to jujulini]

It is not insulting at all. As a person with PD, I do not find it so. The placebo effect and its opposite are all too evident in PD. It also has to be said that part of dealing with our long-term illness is often some depression. All of this is understandable in a problem that is caused by a malfunctioning of brain chemicals and their receptors.

[Kwinholt in reply to Hidden]

I realize we all have our own journey and opinion but I also find it a little insulting for someone to say it’s in your mind. I personally don’t care what color or what size a pill is as long as it works for me and the SUN manufacturer is best for me. My wonderful pharmacist also agrees that genetic manufactured medication are not always the same with their added fillers ect. Like I said before , we know our bodies better then anyone else. K

[Hidden in reply to Kwinholt]

Why would you find it insulting? It is not a great problem for many people but can be a problem for some. My late Father also had PD and lived with it for 28 years. In the late stages he had to change brand of medication and while it was initially problematic, in a relatively short while he found the new formulation to be good for him. He died at 82 of an aortic aneurysm not related to PD. Some may find this helpful: parkinson.org/Understanding...

[CaryAgge]

Very informative post. Thank you very much for taking the time. Will keep this in mind.

[kgold]

I'm not a parkie but can identify with this post having Hashimotos thyroiditis and reacting to changes in my thyroid medication, particularly Armour thyroid in 2009. Have been on compounded thryoid meds until there was no availability of USP powder over a year ago. Since then I've tried 2 different thyroid meds and reacted to both. This problem is real.

[Opt8]

I have non motor pd and just weaned myself off all my pd drugs that are generic. I was developing weird symptoms with bruise like blotches on my skin also swollen lymph glands. Do not know if there is a connection to generic carbon levo, but am trying this experiment. So far blotches and lymph gland swelling is much better.

[Hidden in reply to Opt8]

Any problems like this should be reported.

[Hikoi in reply to Opt8]

Are you taking amantadine? That causes a blotchy rash that is harmless.

[fwes]

Your comment is very important. It opens the possibility that a person who might benefit from a medication might be reacting to an "inactive" ingredient and misleading the physician into discarding the use of that medication rather than seeking an alternative manufacturer. This line of thought leads to a need for the "inactive" ingredients in generic formulations to be disclosed. Curiously, they are disclosed for the original (tested and patented) medication.

[Hikoi]

The inactive ingredients could cause problems but I think the 20% variation allowed by the fda may be significant too. Kgold is a case in point being on thyroid meds (see article) so his/her experience should be treated cautiously.

This article seems to cover all the issues.

huffingtonpost.com/2015/02/...

I live in a country where the govt bulk contracts for meds and so we dont get a choice. Take what is offered (always generic) or buy your own at great expense (and why would you do that when subsidised meds only cost $100yr per household) In addition they change contracts so generics change. While there are some notable times that the newer generic has caused problems (not PD) mostly people just get on with it.

[eaglet]

Important to be aware of

.

[Hidden]

Thank you for this information. I was surprised to find that some of the Carbidopa levodopa generics contain phenylalanine, which is part of what is used to make aspartame. I have read that this ingredient interferes with the absorption of levodopa. One may need to take more of one generic than another because of the interaction with the filler ingredients. Also some have allergic reactions to the yellow die that is used to color tablets. There are even different fillers used in different strengths of the same drug. Ever notice a need to cough after taking some meds?

Also a lot of infant and toddler meds are prescribed based on weight. Ever wonder why this isn’t true with adult meds?