Posted by RMFlorida on September 19, 2009, at 9:56:50
As most of you know, Dextroamphetamine (Immediate Release) in the brand-form (GSK) has been discontinued. Several years ago the competing brand (Dextrostat) by Shire had also been eliminated. Towards the end of 2008, all generics (save Teva/Barr) were eliminated from the market. Mallinckrodt by choice, Ethex by the hand of the FDA.
As it sits, Teva/Barr is the only form of Dexedrine (Dextroamphetamine) tablet available in the US; however, that may not be relevant (see below). Worse yet, this same company (Teva/Barr) is the only manufacturer of Adderall instant-release, as well.
There were more than the usual number of complaints about the quality of Barrs Dexedrine, however, it was not a major issue. That was before Teva purchased Barr just about a year ago, and apparently changed factories/manufacturing processes.
More recently, there was a recall of Barr's Generic Adderall.
In summary: Teva/Barr is the **only remaining manufacturer** of either Adderall or Dextroamphetamine, and for many, Teva/Barr is simply not an option due to the low-quality level, which has become worse since Teva purchased Barr.
Does anyone at the FDA care? How does Barr get away with producing inferior Dextroamphetamine, what appears to be well beyond the legal threshold, and continue unencumbered?
...For those of you who are interested... Ill share the personal story of how I've discovered this information, which may resonate with some of you.About a year ago, at 37 years of age, I was prescribed Dextroamphetamine by a doc that took a much closer look into my problems, than anyone Id seen in the past.
He prescribed Adderall, and I didnt want to take any more than the minimum dosage (5mg) because I was concerned about taking a C-II substance.
Even at this low dosage, the drug did wonders for me. It did so much for my focus, efficiency, motivation, depression, demeanor, and overall mental health. It even helped me sleep better and it helped me stay on a more consistent schedule.
That was a year ago. To be sure I had found the best solution, I had tried both Adderall and Dexedrine. Dexedrine was (in my humble opinion) smoother and less disruptive. I had taken the brand (GlaxoSmithKline) and Ethex, having no side-effects.
Ive always preferred to save money by purchasing generic medications, because up until recently, I swore there was no difference between generics and the brand drugs. I swore that the FDA monitored these companies so closely that generics could never be significantly different. I swore that since the chemical composition had to be identical, that for all intensive purposes, generics were the same as brand-drugs.
Barr has changed my mind. Several months ago, I refilled my prescription for Dexedrine and received the Barr generic (being the only option available any longer). The Barr Dexedrine was terrible, I barely received any benefit with my 5mg dose, and yet my stomach would hurt and I would occasionally get this dizzy sort of headache (difficult to explain, but a very disruptive and distracting feeling that works against focus, the entire point of the medication).
Of course, I thought this was me. Because at the time, I never thought there could be any difference between generics and brand drugs, and Id been taking generics previously without any issue. Never for a second did I think that it was the drug, nor did I think to search the Internet or talk to the pharmacist. I simply thought my body was the problem.
After becoming frustrated with myself (when the Barr Dexedrine didnt work well), I assumed that I must have built a tolerance, and being very worried that I would build a dependency, I stopped taking the Barr Dexedrine after roughly 10 days. I felt much better, although less motivated, once I stopped.
A few weeks passed, and I had a situation that really dampened my outlook on things. I became less motivated, distracted, and essentially unable to focus/be a productive member of society. I thought that it was time to try the Dexedrine again, and yet I ran into the same problem. No effect, stomach problems, fuzzy head, etc.
Again thinking it was me, I eventually went off the medication after roughly 10 days.
Unfortunately, I was still in a difficult place, and felt that it was not a good time to be attempting to go without the Dexedrine. At that point, in a flash of genius, I remembered that I had a few tablets of my last prescription remaining. I had believed these were both the same (until now, I didnt realize how many generic brands existed), but wondered if I had simply stumbled upon a bad batch.
Sure enough, the other generic (Ethex) had none of the issues, and it was much more effective.
I visited the pharmacist, hoping to exchange what I thought was a bad batch of tablets. To my surprise, the pharmacist explained that my previous batches were Ethex and that the current batch, Barr was all he could get. At the time, I didnt think this relevant I assumed I was dealing with a single bad-batch. However, the pharmacist explained that he could not exchange pills, nor could he charge me for purchasing replacements, because its a C-II substance. He said the best he could do, would be to search around to determine if there were any recalls on the product.
Realizing that the pharmacist was too busy to spend any amount of time on this, I returned home and scoured the Internet for information on Dexedrine, assuming to find a recall. Initially, I didnt search for the word Barr, because I didnt realize the significance of this. However, it only took about 30 minutes of searching, to realize that the majority of people sharing information on the Internet, regarding Dexedrine, were complaining about variations in the generics.
I was astounded. Some of these forum posts (particularly one on the ADHD board) read like I had written it. This person suffered the exact side effects as I had. And I was surprised to see there were many skeptics, with a position much like my own position previously, that generics couldnt possibly be responsible for such a severe difference.
Thats where I began searching, to determine the alternatives. I thought surely this poorly made generic is not the only option? After a couple hours searching, running into dead-ends in every direction, I eventually learned what I shared towards the top of this post: there are no other options for either Dexedrine or Adderall, immediate release.
Sure, I could take Dexedrine XR, and pay 4-5 times as much. However, Im not sure thats a good idea, considering one of the major benefits of Dexedrine, is that my body would slow down significantly at night, and it made it much easier to get to sleep / maintain a consistent schedule.
And so I find myself sharing this story... For all of the skeptics that claim there is no difference between generics and brand drugs. For anyone in the FDA that happens upon this story (which Im sure to be highly unlikely). And most importantly, for anyone else who enters these search-terms into Google, hoping to find answers. Perhaps I can save you the time, effort, and frustrating process that I just went through, only to come up empty-handed.
And for those of you in the know, how can we go about bringing this to the attention of someone who will have a look at Barrs seemingly lacking standards of quality-control?
poster:RMFlorida
thread:917673
URL: http://www.dr-bob.org/babble/20090912/msgs/917673.html