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Medical Forum / Diseases and Disorders / Epilepsy / February 2006Bad batch of drugs?
Just recently I switched to a different pharmacy to fill my prescriptions. One of my new monthly refills was for the Pfizer Dilantin 100mg Kapseals that I take 3x daily and I started using them on Monday. My situation always is somewhat volatile in that I can have good days & bad days and don't get too surprised if I have a bad day because I figure things will get better tomorrow and they usually are. That's not actual daytime seizures, but just in how well or poorly I *feel*. In other words, I've been fairly stabilized without actual daytime seizures except for the nighttime events which my neurologist apparently has no plans of addressing. Since I started taking the new Kapseals, I've felt pretty bad every day and my nighttime events have gotten worse. I've analyzed everything else that I log on my daily calendar such as activities and foods eaten and the Dilantin seems to be the only common factor, although maybe I was just simply getting progressively worse anyhow and it has nothing to do with it. My memory is not all that great, but I seem to recall that I've had ups & downs from refill to refill to some extent in the past, but never anything like this. Has anyone else had an experience like this? So are the Kapseals a different formula than you are used to? Sorry I am not familiar with that one. If it is different it sure can be affecting you. Dilantin is a tricky med, a slight change can cause a big change in your serum level. I would call your neuro Monday and see what he thinks about it. he can write DAW(dispense as written) and they have to give you the same version each time..... Sorry you are having a rough time. My son was on the generic for a time and he did have a lot of ups and downs. I have since learned that the name brand Dilantin is better at keeping steadier levels. It is still a tricky one. Hang in there. Hope you do better soon. G > Just recently I switched to a different pharmacy to fill my > prescriptions. One of my new monthly refills was for the Pfizer Dilantin [quoted text clipped - 14 lines] > just simply getting progressively worse anyhow and it has nothing to do > with it. You could ring the Pharmacy to see if they substituted a Generic for what was written (often price drop could show that too, but get their attention by telling them they aren't working and you wanted to know before you call the Neuro about your seizures). Call the Dr. and ask if they'd agree you should have a non-substituted version of Dilantin. They should still be as cheap -- the patent (?) was paid off in about 1930, so original or clone costs should be similar. Ask them to ring the pharmacy and tell them to put 'no substitutions' on your File, or if you're due to see him again, have them write a new prescription with *that on the script-- give it to the pharmacy for the next time you need a refill, or if you're still having szrs. or effects, have it filled and take the old pills to them to Discard for you. Tell them when you do that what they filled are failing for you. That way if Others are taking that batch in, they'll be more careful next time with other pills. G.R./ (I found Dilantin gave me erratic seizure control, and was only on it about 5 months for complex partial seizures, then moved to another stronger but time released pill. Night and Day difference in quality of control and lifestyle, but may not be compatible with your type of szr. My Neuro said it's done first as it's cheaper (above patents stuff), and longer studied, but Tegretol and some other pills are also more than 30 years old now too, although there are about 6 versions of that too... :-< ). > My memory is not all that great, but I seem to recall that I've had ups > & downs from refill to refill to some extent in the past, but never > anything like this. Has anyone else had an experience like this? > Just recently I switched to a different pharmacy to fill my > prescriptions. One of my new monthly refills was for the Pfizer Dilantin [quoted text clipped - 14 lines] > just simply getting progressively worse anyhow and it has nothing to do > with it. You could ring the Pharmacy to see if they substituted a Generic for what was written (often price drop could show that too, but get their attention by telling them they aren't working and you wanted to know before you call the Neuro about your seizures). Call the Dr. and ask if they'd agree you should have a non-substituted version of Dilantin. They should still be as cheap -- the patent (?) was paid off in about 1930, so original or clone costs should be similar. Ask them to ring the pharmacy and tell them to put 'no substitutions' on your File, or if you're due to see him again, have them write a new prescription with *that on the script-- give it to the pharmacy for the next time you need a refill, or if you're still having szrs. or effects, have it filled and take the old pills to them to Discard for you. Tell them when you do that what they filled are failing for you. That way if Others are taking that batch in, they'll be more careful next time with other pills. G.R./ (I found Dilantin gave me erratic seizure control, and was only on it about 5 months for complex partial seizures, then moved to another stronger but time released pill. Night and Day difference in quality of control and lifestyle, but may not be compatible with your type of szr. My Neuro said it's done first as it's cheaper (above patents stuff), and longer studied, but Tegretol and some other pills are also more than 30 years old now too, although there are about 6 versions of that too... :-< ). > My memory is not all that great, but I seem to recall that I've had ups > & downs from refill to refill to some extent in the past, but never > anything like this. Has anyone else had an experience like this? >> Just recently I switched to a different pharmacy to fill my >> prescriptions. One of my new monthly refills was for the Pfizer Dilantin [quoted text clipped - 19 lines] > attention by telling them they aren't working and you wanted to know > before you call the Neuro about your seizures). Thanks to you and guitarmom for the replies, but generic substitution is not an issue in this case. Pfizer Dilantin Kapseals are a very specific brand name product and can be identified by being a white capsule with the reddish band around them. There's a picture of them here http://www.epilepsy.com/medications/b_dilantin_intro.html My new refill capsules look exactly like the old and the outside of the container is labeled properly. I had given them very strict orders when I setup the account and had told them that one reason they were getting my business was that the other pharmacy had made a substitution on me. In that case, I've been taking Pfizer Neurontin 600mg for years and the doctor gave a prescription for some 300mg so I could try something. That was filled with generic Gabapentin without any question being asked whatsoever of me. They should have caught that in my opinion and it speaks to their competence. > Call the Dr. and ask if they'd agree you should have a > non-substituted version of Dilantin. They should still be as cheap -- [quoted text clipped - 7 lines] > failing for you. That way if Others are taking that batch in, they'll > be more careful next time with other pills. G.R./ I'm dealing with the very same product, but have to wonder if there is any variation from batch to batch. They certainly must have quality control for their production line, but there would be room for upper and lower percentage limits during the manufacture of the drug itself and again during the filling of the capsule. There would be different, but similar, conditions of storage and shelf age of product from vendor to vendor out in the distribution chain. I'm just reaching for any explanation of what might be going wrong. > (I found Dilantin gave me erratic seizure control, and was only on it > about 5 months for complex partial seizures, then moved to another [quoted text clipped - 7 lines] >> & downs from refill to refill to some extent in the past, but never >> anything like this. Has anyone else had an experience like this? It's probably just me and a cycle or new phase in my condition, but it's all so coincidental that I have to wonder. I think I've experienced a difference from refill to refill in the past, but much more minor. For me, Dilantin wasn't a first try, but is at the end of a road that went unsuccessfully through Neurontin, Keppra, Tegretol, Lamictal, Phenobarbital, and Primidone. I've been taking 400-500mg Dilantin for the past 2.5 years and can report similar experiences with the "ups and downs." The only way I can really tell what's going on is through blood serum measurement. I have only used generic form from the same supplier throughout. >I >have only used generic form from the same supplier throughout. The potency of generic Dilantin is related to the length of time since it was manufactured. It could have been fresh on the druggist's shelf when you bought it, or it could have been there for months. That could explain the differences in effects. When I prescribe Dilantin, I always prescribe the trade-named brand (Parke-Davis). It costs more, but it works much more consistently. Best, Bob Robert A. Fink, M. D. Neurological Surgery 2500 Milvia Street Suite 222 Berkeley, CA 94704-2636 USA 510-849-2555 ********************************** NOTE: The material above is not "medical advice". Medical advice can only be given after an in-person contact between doctor and patient. ********************************** >>> Just recently I switched to a different pharmacy to fill my >>> prescriptions. One of my new monthly refills was for the Pfizer Dilantin [quoted text clipped - 46 lines] >> failing for you. That way if Others are taking that batch in, they'll >> be more careful next time with other pills. G.R./ I suspect that the Kapseals are the issue. The Kapseals (Parke-Davis branded Dilantin) are sealed and moisture cannot get inside. Phenytoin, the medicine itself, breaks down in the presence of moisture, and so, if non-sealed capsules (the generics) stay around for a while, they lose their potency. This is one of the reasons that when I prescribe Phenytoin, I always specify "Do not substitute" and request the branded Parke-Davis "Dilantin" version. Medicaid in our state, some years ago, tried to deny coverage of the branded Dilantin (to save money), and patients whose seizures had been controlled for years started to have seizures. We complained to the Epilepsy Society and Medicaid reversed themselves, now paying for branded Dilantin. Best, Bob Robert A. Fink, M. D. Neurological Surgery 2500 Milvia Street Suite 222 Berkeley, CA 94704-2636 USA 510-849-2555 ********************************** NOTE: The material above is not "medical advice". Medical advice can only be given after an in-person contact between doctor and patient. ********************************** >>>> Just recently I switched to a different pharmacy to fill my >>>> prescriptions. One of my new monthly refills was for the Pfizer Dilantin [quoted text clipped - 55 lines] > specify "Do not substitute" and request the branded Parke-Davis > "Dilantin" version. Thanks for your reply Bob, but I didn't quite follow you there. As I initially wrote and have emphasized again in other replies, my Dilantin in all cases has NOT been generic, but has been the proprietary/brandname (Pfizer/Parke-Davis)Kapseals. That's what I'm guessing has lost some effectiveness in this latest refill from a different pharmacy chain. I guess you must mean that those also can loose some potency if left on the shelf too long? The pharmacist wrote discard after 8/06 on the label. My memory being what it is nowadays, I can't state this with certainty as I didn't log it at the times, but I believe that past prescriptions have sometimes varied from month to month and I would notice an immediate improvement upon taking the Kapseals from a new fresh refill. > Medicaid in our state, some years ago, tried to deny coverage of the > branded Dilantin (to save money), and patients whose seizures had been > controlled for years started to have seizures. We complained to the > Epilepsy Society and Medicaid reversed themselves, now paying for > branded Dilantin. I read about generic substitution causing patient problems like that and also of being tripped up within a brand name like Pfizer/Parke-Davis. Just the difference between taking the sodium salt form (Kapseals) and the free acid form (Infatabs) can cause problems as I'm sure you know. At a time when a small extra dose was indicated to supplement my 3x100mg/day Kapseals, my doctor, for whatever reason, prescribed 1x50mg Infatab instead of 1x30mg Kapseal. That didn't quite work out for me and it wasn't until some time later that I read of the possible reason why. I think what he (Dr.Bob) meant was that even though you are using the Branded Version, that they still have a finite shelf life, and you *might have received a batch (1) which was near its 'best before date' (to use an analogy from foods). That was not the same as I wondered (earlier) about whether you had been using a generic vs. the Manufacturer's product. G./ > I think what he (Dr.Bob) meant was that even though you are using the > Branded Version, that they still have a finite shelf life, and you > *might have received a batch (1) which was near its 'best before date' > (to use an analogy from foods). > That was not the same as I wondered (earlier) about whether you had > been using a generic vs. the Manufacturer's product. G./ Thanks and yes, I think that must be what he meant. It must have something to do with the progression of my condition(s) or the meds or something, but if anything ever has even the tiniest amount of ambiguity to it, I can't rest until I figure it out or go nuts trying. I've been driving my wife crazy lately. :) >Thanks for your reply Bob, but I didn't quite follow you there. As I >initially wrote and have emphasized again in other replies, my Dilantin [quoted text clipped - 24 lines] >Infatab instead of 1x30mg Kapseal. That didn't quite work out for me and >it wasn't until some time later that I read of the possible reason why. The Parke-Davis brand (with the sealed Kapseals) should not deteriorate due to moisture. If they were kept under bright light, or at high temperature, they could lose potency. Most anticonvulsants have a "narrow therapeutic index" (the difference between the effective dose and the toxic one) and so, the drugs should be stored carefully, whether at the pharmacy or in the home. Best, Bob Robert A. Fink, M. D. Neurological Surgery 2500 Milvia Street Suite 222 Berkeley, CA 94704-2636 USA 510-849-2555 ********************************** NOTE: The material above is not "medical advice". Medical advice can only be given after an in-person contact between doctor and patient. ********************************** Thank you. I wondered if it could have been something like that (storage or handling of a med.) G./ > Just recently I switched to a different pharmacy to fill my > prescriptions. One of my new monthly refills was for the Pfizer Dilantin [quoted text clipped - 18 lines] > & downs from refill to refill to some extent in the past, but never > anything like this. Has anyone else had an experience like this? I have some information to add. Because of the confusion over it not being understood that I have always been taking the proprietary Pfizer Dilantin 100mg Kapseals and never a generic, I'll start with my original post above. I've realized what might be the possible importance of the "Discard by 08/06" (August 2006) on the refill from the new pharmacy. I have the empty container from the last refill from the old pharmacy. It was filled in November and has a "Discard by" of 11/06 (November 2006). The other old empty containers from the old pharmacy always have a "discard by" that is one full year from the date of the refill. I assume that Pfizer specifies how long its product lasts before losing X% of its potency. I also assume that one year period labelling is a standatd and FDA regulated to be on the label. Even though the Pfizer Kapseals aren't as subject to moisture damage, it appears they lose their effectiveness in one year (assuming the old pharmacy was getting them in fresh). That being the case, my new refill was already 4 months old and had lost that much of its effectiveness? It seems like it anyhow from the regression I've been experiencing and I've lost a lot of the recent progress that I'd made over past months. Or it still could all be a coincidence. Heaven knows. |
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