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JerryUPMI

Generic Tegretol XR manufacturers: from Sandoz to Taro

Hello everyone. (If you don't want to read a long, rambling post, skip to the last couple of paragraphs for the meat of it!) I have been lurking for awhile but haven't felt compelled to post until now. First, just a little background: I suffered a grand mal seizure, sending me to the ER, at the age of 13 in the year 2000. This was followed a few days later by a major aura that never progressed beyond that. It was totally unexpected and not explained by a couple (each) EEGs and MRIs. I was medicated for three years subsequently, first on Tegretol and then Tegretol XR, under which I felt in complete control and never had another seizure. I stopped driving for a period of six months to go off medication, and I never had another episode of any kind for years.

Fast forward to April 2011: I had another ER-worthy (and stitch-worthy) grand mal out of the blue, was medicated by Keppra and later Depakote, and moved back to my home state in July after managing to finish my Master's Degree. I moved back for my "dream job," which I managed to get despite being unable to drive for a time, when driving is normally an essential requirement of the position. The expected driving deadline was pushed back when I had another grand mal--AT WORK--sending me to the ER, followed by another one at home on the same night, sending me back again, after which I was admitted for the night. With no neurologist available the next day, a hospitalist added good ole Tegretol XR to the mix. After considerable time and difficulty, I weaned off the Depakote and now the Keppra to end up on Tegretol XR (generic), 600 mg twice a day.

I have just recently stabilized, for the most part, and am obviously reluctant to make any more medication changes at this time. But when I went to get my first Tegretol XR refill under monotherapy, I saw a dreaded sticker: "This is the same medication you have been getting. Color, size or shape may appear different." This threw me for a loop because 1) I had some trouble with a short stint of generic carbamazepine years ago, and 2) many people here warn against switching generics. I wasn't even aware until then that the original version I had been receiving was a generic, but this NEW generic looked COMPLETELY different, not just in appearance but in form of release. For those familiar with Tegretol XR, it consists of an indissolvable shell with a small hole in it, with carbamazepine inside. The carb is released slowly through the hole. The new drug had no hole; it was all made of a uniform material--more comparable to Carbatrol than Tegretol.

I was hesitant to accept this new manufacturer's version of generic and told the pharmacist so, but finally I gave in because she said that was their new supplier and the pharmacy were not able to get the old version.  I assumed (correctly, it turned out) that most other stores would be following suit. I had considerable reservations after further research here and elsewhere, so I started calling around to see if there was some way/place to get the old version or the brand name instead. This involved working through a new neurologist's office and a doctor and nurse I had never spoken to before, since the one neurologist in my local branch of that office was out sick. It also involved calls to several pharmacies, including numerous calls to and from the original pharmacy.

Here is what I found out that may interest some of you who take generic Teg XR: The old version I was taking is apparently the original version of the 200 mg tab generic. It is manufactured by Sandoz, which is a subsidiary of Novartis, the manufacturer of brand-name Tegretol. This is why it looks virtually identical. Recently in my area there has been a wave of wholesalers and pharmacies switching from the Sandoz version to one made by Taro, the unlikely-looking relatively new generic. In the largest concentration of small cities in my rural area, there are around ten pharmacies. None of them stock the Sandoz version anymore. I finally found a couple of more isolated pharmacies that still have some. However, the lack of Sandoz looks not to be permanent: There is a shortage of the Sandoz, so my main pharmacy should be switching back to it eventually; in the meantime I will be obtaining supplies from the two or three pharmacies that have small supplies left, and for the next couple of days I have a very small supply of brand-name pills, which my insurance refused to pay for without "prior authorization," even though I had gotten a new "dispense as written" script.

The thing that really boggles my mind about all this is that the Taro generic not only appears different but clearly has a completely different controlled release mechanism than both the old generic and Tegretol XR itself. I would like to ask the FDA or someone else educated on this subject how that can be considered equivalent. It would be pretty tough to convince me on that one, and I don't want to be the guinea pig.

Finally, I don't want to start an all-out "generic vs. brand name" discussion, but do you think I was right to be especially concerned in this case? I felt vindicated to some extent when I found out the original Sandoz generic was Novartis-manufactured. Still, the nurse, doctors, and original pharmacist, while they all understood my feelings and concerns, thought there was really nothing to worry about. To their credit, they went out of their way to work through this with me, and I am pretty happy with the outcome-- something to be thankful for.

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