Perhaps this topic has already been discussed, here, but I felt it would be worth posting my harrowing experience with generic manufacturers. In all my years, this had never occurred to me UNTIL my pwp manifested horrific mental difficulties. Neither I nor her neurologist could imagine what happened to her...only that her PD might be progressing which seemed unlikely in that the change in my pwp seemed to occur "overnight". I can only attribute to someone greater than I to have led me to even think about the difference in manufacturers. As far as I had known, the generics were required to contain the exact active ingredient as the Brand. I began to think...on my own...that perhaps the "ratio"of that generic ingredient could be "slightly off"which for any PD medication could be an important factor. I finally researched all this on the internet, and I was shocked to find how "off"the active ingredient can be, i.e., that the generic manufacturers bioequivalence of a generic can definitely be "off"which can account for a problem in using specific manufacturers of generics. I went through 3 months of agony and heartbreak watching my pwp virtually "out of her mind"...not knowing how to do things she had been able to do..not being able to communicate...it was the most horrible experience I had had throughout my pwp's 16 years of having PD. Most probably, all of you already know about what I have written...but, just on the chance that it could be new "news"for ANYONE was worth my having written this.

Virginia

Virginia,
Brand name drugs are not much better. I've had the pharma's change formulation due to mergers and the new pills don't work as well.
Geraldo

Thank you, Geraldo, for your response. It seems, then, that whether it be Brand or Generic...the formulation can be the culprit. Neither seems to have to adhere to the bioequivalency guidelines, then. It just happened that two of the generics that she had been taking...one for Mirapex...the other for Amantadine...changed manufacturers and that is when the difficulty occurred. Before this, both generics and the manufacturers of THOSE generics worked just fine for her. I have to say that when I researched all this on the internet, I couldn't believe that the manufacturers of medications could stray so far from the exact ratio/formula, and that this could cause such a horrendous outcome for people taking these medications. I think it is particularly important when dealing with PD medications because I believe that even the least deviation can result in terrible outcomes for the pwp. Thank you again, Geraldo, for your response.

Virginia

the take away here is try to keep a month's supply of each medication if possible in reserve in case you get a less effective generic or there is a supply chain interruption. mfg's can get shutdown, natural disasters, contract disputes happen. seems with climate change there's a greater chance of not being able to easily get meds.

and call your pharmacy, insurance company and doctor the minute the problem arises, especially your insurance co., i assume they want you to be healthy and can contact their pharmacy benefits management company with your complaint.

i believe that to meet FDA requirements, generic mfg's just have to give their drug to healthy individuals after which drug blood levels are measured. doesn't mean they don't test on actual patients and/or animals and measure the affect, would be interesting to find out if they actually do.

I was given a generic last November and didn't realize that there could be such problems. I experienced 4 to 6 hours of nausea every day for about four weeks before it occurred to me that perhaps the problem was the switch to the generic. I tried to switch back to the original drug but that didn't work either. So I went to Neupro instead of ReQuip XL and the patch worked great except that the first month of the drugs cost $500 and after that it was $200 a month instead of the cheap Requip XL. I used the patch for three months and, hoping that my system was cleared, I switched back to Requip XL about three weeks ago and I am just fine. But it was a darn scary experience.

Thank you, Soccertese and Nan Cyclist for your responses. I always thought at all generics were manufactured in the same way...just that they had to have the active ingredient the same as the Brand...but, as I've already mentioned, this is NOT the case. Yes...the active ingredient does have to be the same as the FDA guidelines state...BUT, it is the active ingredient that is not always at the same ratio...can be just a little "off", i.e., as I read in all the articles pertaining to this...the bioequivalency is NOT the same and just this seemingly non-issue in manufacturing the generics is enough to cause great difficulties...especially for pwp's. As you mentioned, Nan Cyclist, it's very scary. I had 3 months of agony watching what was happening to my pwp...not knowing what had happened to her in such a relatively short period of time. Another instance just occurred with me related to the medication that I take for the breast cancer. I have been so alert to what can happen with the various generic manufacturers that I noticed immediately...when I had my bc medication refilled...it was a different mfg. Previously, Mylan was the mfg. When I questioned this at the pharmacy, I was told that Mylan no longer makes it. Not quite being satisfied with that answer, I called Mylan and was told that it is TEMPORARILY UNAVAILABLE. I then said to the "rep"that the word "temporarily"could mean that they may begin to make it again, and his response was "yes"...that I should check with my pharmacy a little later on who, in turn, should check with the retailer to see if, in fact, Mylan does have the medication. In the meantime, I had to take the generic that the pharmacy gave me...Apotox was the mfg...and, of course, I was leery but it seemed I had no choice. After taking the substitute mfg. generic, I noticed some digestive problems which I did not have when taking the Mylan...different mfg.??? Perhaps it is coincidental...but, I did NOT take the new "med"last night, and I seem not to have the digestive problem...all this could certainly be coincidental, but it certainly has me questioning the mfg. of the new "med"! It is bad enough to have to take these medications...never mind having to be concerned about how they're made, etc. Thanks, again, for the responses. Soccertese...I will keep in mind what you suggested about having a good supply of "meds"on hand...thank you.

Virginia

100mg levadopa = 100mg levodopa. Not always.

The anecdotal evidence for variations in the quality of our medications is strong. Now we have some quantification of the issue.

Gasser et al. have compared "the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar / Prolopa 125, Roche, Switzerland)". [1]

For instance, four different tablets from four generics contained between 94.4% and 98.2% of the advertized levodopa dose.

They also found that "All products contained impurities, exceeding the limits by 79% in one generic product".

By its very nature sampling just some of the drugs produced leads to an underestimation of the problem. Who is to guarantee that ALL pills of ALL medications at ALL times have no worse composition?

Reference

[1] "Pharmaceutical quality of seven generic
Levodopa/Benserazide products compared with
original Madopar / Prolopa"
Urs E Gasser1, Anton Fischer2, Jan P Timmermans2 and Isabelle Arnet
BMC Pharmacology and Toxicology 2013, 14:24
http://www.biomedcentral.com/content...6511-14-24.pdf

John

not sure if mfg's test every lot but recalls are by lot#.
for carbidopo/levodopa IR i always get TEVA and for CR MYLAN. MYLAN costs more than other generics so I pay more than my copay to get it.

So always a good idea to not let your medication supply run down to zero in case there is a problem with a different generic or lot# or even disruption in the supply chain.

i'm not even sure if any carbidopa/levodopa ingredients are manufactured in the U.S. or western europe.

by many of our brethren, ever since generic levodopa hit the market. WE (the "lab rats") concluded that although the generic companies satisfied the FDA that they indeed did have an equivalent product, this was not always perceived so by too many of us. The only thing that i could think of why this could happen is, as has been mentioned, the generic perhaps had slightly different crystalline form, which altered the pathways of absorption and thus distribution, which then goes on to metabolism and finally excretion. Thus, the postulate was that the pharmacodynamics and thus the fate of any dose of L-Dopa might be different due to some process used in the production that the more experienced manufacturer had. This interested me because one of the synthetic chemical routes to L-Dopa, is called a "chiral synthesis" in order to optimize the production of L-Dopa over D-Dopa. D-Dopa has a different pharmacological profile and is considered inactive against PD. It would be easy to screw up a batch of L-dopa, making it to enriched in D-Dopa and that could cause big problems. But the generic company is by law expected to have analysis of every batch, but this is where, there can be "problems"

I used an off brand of amantadine (red coated caplet). Had beautiful hallucinations. When I was able to get regular, usual pills. they went away.