Tuesday, June 5, 2012

When a Generic is not Generic

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Ah medicines, such a wonderful part of my life.  My latest saga made me find out about the possible hidden problems in switching between generics, of which I was previously unaware.

When I went to the pharmacy last month to pick up a refill of a prescription for oxcarbazepine, I didn’t initially notice that the generic brand the pharmacist gave me was different than the one I usually take.  Oxcarbazepine, or its brand name trileptal, is an anti-seizure medication that I take for autoimmune neuropathies.  (In my case, my cranial nerves or the nerves coming from the brain have been negatively affected by Sjogren’s and this medication provides some incomplete relief.)  Lucky me, I noticed the difference once I started taking this other generic form of the drug.  First, I felt particularly groggy and sluggish on the different generic. Then I noticed that the drug was just not working and my face in particular felt numb, and I was in more pain than usual.  In my opinion, being in more pain than usual for no good reason is unacceptable.

I went to talk to the pharmacist, but that provided little help.  I asked if he could order the brand that I usually take (manufactured by Cadista) and he said that "it was not available" and that the generic manufacturers of drugs change all the time.  He appeared unconcerned by my predicament, and seemed to regard the distinction I was making between generics as irrelevant. This didn’t sound quite right to me since I had been taking this brand of my medication for over a year...so I started making phone calls.  I got in touch with Cadista directly and was told, low and behold, that they were still manufacturing my prescribed dosage of the medication. 

Well, I then knew my neighborhood pharmacist not only didn’t take seriously the problems I was experiencing, but he was also wrong about what was possible.  I went the route of working with my neurologist and my insurance company’s mail order pharmacy.  The mail order pharmacy said that they would be able to order the Cadista brand of the medication and that either I or my physician could request if a specific generic brand was preferred.  Just to make sure that all my bases were covered, I asked my physician write the three month mail order prescription specifying the Cadista brand so that there would be no confusion!  As our own patient advocates, it is often a time consuming and frustrating process to get even what should be small medical details handled.

While sorting through all this to get the medication that I needed, I couldn’t help but think that other patients might have had similar problems switching between name brand and generic drugs or between generic brands. I already knew that generic and brand name drugs have the same active ingredients, but they do not need to have the same inactive ingredients.  My big finding was that the category of drugs, anti-seizure medication that I am on are a particularly tricky problem. The FDA requires concentrations of generic and brand name drugs in the blood stream are within a very close statistical range before they are approved.  However, what the acceptable deviation ought to be for some drug categories is much less clear.

First, it turns out there is a specific open question as to whether switching brands can cause an increase in seizures in some patients and whether the FDA standards for differences in blood level concentrations between brand and generic seizure drugs needs to be narrower for this class of medications (Some generic cardiac, thyroid, and anti-depressant medications have also been of concern).  Then, just to make this issue even more complicated, a recent study from the University of Connecticut and Hartford Hospital indicates that it might not be the difference between brand and generic drugs that can cause problems for patients, but the actual switching itself whether it is between generics or a generic and brand name drug.  Currently, the FDA has three studies in the works to look at these very issues with regard to the efficacy and safety of generic and brand anti-seizure medications.  So, not only was my pharmacist wrong about the differences between generics and the availability of my generic, but he was also woefully uninformed about the particulars of anti-seizure drugs.

I asked a few doctors and started reading online and found out that this was a real problem.  One of the major concerns that physicians have is that, similar to my experience, patients might not even be notified when they are given a new version of a generic anti-seizure medication when refilling their prescriptions.  Pharmacists are not required to give this notice.  Patients also have little control to remain on specific generic medication because pharmacies often change which brand they carry based on issues such as lowest cost and availability of supply. The American Academy of Neurology has put forth two position papers expressing “concerns with generic anti-epileptic medication and that physicians should approve all generic substitutions.”  This would mean that pharmacists could not substitute generic seizure medicines for a brand name without a doctor’s consent.  

Luckily in my case, I was not at risk of a seizure, but I did have adverse side effects from switching between generic anti-seizure drugs.  My take away from this experience like many of the other medical adventures that I have had is that I cannot always rely on medical professionals for help and to provide important information. And I have to trust my instinct when something doesn’t seem right with my health and press forward for answers.  While I do admit it can be tiring and sometimes I want a break, that is what having a chronic illness and being your own advocate requires. I don’t feel that I really have a choice in this one.

Have any of you similar problems with switching between generics or generic and brand versions of the same medication?  Are there other specific conditions that you know patients need to watch out for when switching?

Cake Health. Are Brand Name Drugs Better Than Generic?
Epilepsy Foundation of Connecticut. Press Release.
FDA. Facts About Generic Drugs.
MedPage Today. Generic Seizure Drugs Vary Widely in Bioavailability.
MedPage Today. Generic Versus Brands: How it Plays out in Practice. 
New York Times. Not all Drugs are the Same After All.
ScienceDaily. Substitution of Generic Drugs May Cause Problems for Epilepsy Patients.
UConn Today. Study: Switching Anti-epileptic Drugs Could Increase Risk of Seizures.
Wall Street Journal. Inexact Copies: How Generic Copies Differ From Brand Names.

1 comment:

  1. I know I am writing on an older post, but this is wonderful information and I want to thank you for making it available. I have Sjs, and Trigeminal Neuralgia. I am very sorry that you have these issues as well, but I am so glad to read about someone else with the same thing. I have read other posts, here and there from your blog, mostly as linked from the Reasonably Well blog, but somehow I didn't catch that you also had neurologic pain. I will now definitely follow your page as well.