My Seizure Medicine Has Been Recalled

[Shutterbabe]

I discovered several days ago that the medication I use at the onset of seizure, Klonopin Wafers 1mg, manufactured by Hoffman-Roche, has been recalled due to a problem with their 2mg dose. This tablet has truly been a lifeline for me.

After hearing this news from my pharmacist, I phoned my doctor. I was given several options: call the manufacturer in NJ, consider a compounding pharmacy who might be able to duplicate the wafer or try another medication.

Hoffman-Roche was absolutely no help when I asked questions. Their "nurse" was quite rude, saying they issued a notice 2 weeks earlier. She could not understand the gravity of my situation. I told her I had just found out when I tried to renew my monthly prescription. I asked to speak to a supervisor but was told she was away from her desk. I left my number but she never called me back. I phoned a second time and was greeted by a very sincere employee who was able to connect me with someone in the higher echelons of the company. I am awaiting more information this week to see if this is a permanent recall.

I cannot take the generic version of clonazepam wafers as they make my heart race The compounding pharmacy could not help me with a substitute. Their version was too slow acting. My doctor tried to find a comparable medication but in the end prescribed an oral Klonopin tablet, which he said I should chew in the event I felt a seizure coming on. This is not a feasible option for me. To add to my problems, my insurance company would not pay for it once it was prescribed. Guess I will spend some more time on the phone tomorrow on that one.

Can anyone suggest another orally disintegrating medication such a Klonopin? Is there something else that you have had success with pre-seizure?

I have been "essentially" seizure free for the last 14 months and have been
able to prevent episodes using this wafer. I spent all day Friday doing research and on the phone without any satisfaction.

I only have 12 wafers left and I am beginning to panic. I would appreciate any insights. I have hit a wall trying to be pro-active for my own health.

[Shutterbabe]

The manufacturer of Klonopin Wafers is Hoffmann-LaRoche. Mea culpa.

[Kansas Educator]

What a bummer -- I hope you can get things figured out soon.

What warning do you have that your seizure is coming? It sounds like things were working well. Keep us updated.

[Shutterbabe]

My left foot and toes begins to twitch and twirl at the onset. I also get a very strange feeling in my right leg. I have managed to keep myself "safe" for much of my seizure history as there are subtle symptoms: fatigue, strong emotions and a sensation at the base of my brain, as if I am on another frequency.

I have been blessed with just small events that have not manifested into full seizures since April 2008. I feel like I am living a very full life now. If I did not have to take anticonvulsants 3 times a day, I might almost forget that I have a neurological condition.

The loss of this medicine makes me feel vulnerable again.

Thanks for your message.

[Ann T.]

Hello, Shutterbabe:~)
At my last appt earlier this month, my neurologist prescribed an orally disintegrating 'melt in your mouth' clonazepam pill made by PAR Pharmaceutical Cos. in Spring Valley, NY 10977. I usually take a 0.5 mg, but you may want to contact them to see if they have the dosage you need. I paid $6.67 for a 1 month supply. In fact, I'll see if I can locate a phone number or website & I'll return ASAP. Take care!

[RobinN]

How is it that these sublingual medications are such low doses? .5 - 1.0 mg seems so low when others are beginning doses of 100 mg. Are they made stronger? Still I would think the actual medication would have to be listed at the same strength / mg.

[Ann T.]

Hey, Shutterbabe! :~)
I 'googled' the info on the back of my clonazepam 'melt in your mouth' tabs & I've returned with the info which will (hopefully) help you solve your delimma:
ADDRESS: PAR Pharmaceutical Incorporated
1 Ram Ridge Road
Spring Valley, NY 10977-6714
PHONE #: (845) 425-7100
WEBSITE: www.parpharm.com
Best Wishes to you & please let me know if this info worked out for you. Thanks!

[Ann T.]

Hi, Robin:
I think the sublingual meds are stronger. Clonazepam is a very powerful medication, at least for me. I take it on an as needed basis to calm continuous complex partial seizure activity in my brain when it occurs. I tried the 1 mg tablet, but it put me to sleep for half a day, so I was prescribed the 0.5 mg tab. My neurologist told me that the orally disintegrating tabs do not require water & they absorb much more quickly into the mucous membranes than the standard tablet.

[Shutterbabe]

Hello Ann,

Thank you for your kindness and information. My pharmacist also told me about PAR as a generic alternative. I had tried a replacement drug from another company in the past and it almost caused a seizure, heart issues. I will follow your link and see if PAR's product is purer than the one I tried made by TEVA. I have had tremendous success with the brand name drug and dread experimenting with something new.

This has truly been an unexpected jolt in my recent well-being.

You are right about Clonezepam being very powerful. I began with the 0.5mg dose and
it was a lot of medicine for me. I now take 1mg of it at bedtime ( I have a history of night seizures) with Trileptal. It leaves me very drugged out each morning but I cannot complain as it has been effective.

I will let you know how all this unfolds.

With Gratitude, Jill

[Bernard]

Hi Shutterbabe, nice to see you again, sorry it's because of dire circumstances. Stacy had problems with generic formulations of Dilantin and had a few problems when they reformulated the brand name too, so I sympathize with your plight.

Here's the FDA announcement for the recall:

PRODUCT
Klonopin Wafers (clonazepam orally disintegrating wafers) CIV, 2 mg, carton of 60 blistered wafers (10 x 6), Rx only. NDC 0004-0283-22. Recall # D-414-2009
CODE
Lot number: U5011, Exp. Date 3/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoffmann La Roche, Inc. Nutley, NJ, by letters on March 26, 2009.
Manufacturer: Cardinal Health, Swindo, UK. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
957 units
DISTRIBUTION
Nationwide

http://www.fda.gov/Safety/Recalls/En.../ucm161396.htm

It appears to be just a specific batch that was recalled.

[Shutterbabe]

Hello, Bernard-

Thank you for the detailed information on the recall. Hoffmann-La Roche was very defensive when I called and asked them specifics. I do not know if they will re-introduce the medication. They took all doses off the shelves, leaving me with an urgent problem to find a replacement. Generics seem so "iffy" and I do not wish to experiment with a new drug if a seizure begins.

You bring up a good point that I did not consider. Even if my medication is released after the recall, it might not be the same.

I will keep everyone posted. In the meanwhile, I welcome responses to this situation.

I am grateful to CWE for being a constant source of compassion and intelligence.

My best wishes to you and your family, Bernard.

[Shutterbabe]

I received a phone this afternoon from a supervisor at Hoffman-La Roche
with more information on the recall of their product. She was very gracious
and told me that they are uncertain when this medication will be re-introduced. She felt that I needed to pursue other options to maintain my
health at this juncture.

Debra offered to keep in touch with me on a weekly basis or if there is any breaking news regarding Klonopin.

As I had an unsatisfactory experience with my first call to Hoffmann-La Roche I can report that this representative was deeply concerned and immediate in acknowledging the difficulties that patients like myself are facing.

I will share any information that I gather with CWE.

Good Wishes to All......... Jill

[debanks]

Funnily enough Shutterbabe I used to work for Roche Pharmaceuticals in the UK and I have to confess I had not heard of this product before. In the UK they sell Klonopin as Rivotril. Not sure if you can source it from here?

check out Roche's uk page.

In regards to generic drugs, no they aren't ever exactly identical but if you can get something you can tolerate then go for it - most do a good job. I wish you lots of luck with it.

To Robin - The dose is all down to the potency (or strength if you like) of the medication. Therefore the higher the potency the lower the dose needed. This is why you get differences in drug dose, even when comparing different drugs in the same class/type. Hope this makes sense!

Wikipedia has a item on drug action (see section on potency)

[Shutterbabe]

Thanks for the data. I am familiar with Rivotril as it was the version of Roche's Klonopin I used while living in Mexico.

I am looking at buying my medication perhaps in Canada. I am unsure if
the recall is solely in the USA. I never considered the UK in my search.

I am not comfortable with "road testing" generics when it comes to my epilepsy but this might be my only option. Some are better than others,
of course, so I will continue on my quest.

Again, my gratitude for your insights. Stay well, please.

[alivenwell]

Generics were my only option when Mysoline was temporarily off the shelves until new manufacturing equipment produced acceptable quality. I temporarily went to generics for the first time in many many years. Like you, I have excellent control and really want to retain that quality of life.

If you do switch to a generic, get a blood test of levels of the medication and a liver function test. If it works, take note of the appearance of the generic company's letter/numeric code on the wafer. Apothecaries have the ability to reproduce medication and retain the same fillers and therapeutic level. They're one option to try.

[Shutterbabe]

Thank you for your response and suggestions. It sounds like you understand this problem quite well. I did go to a compounding pharmacy today and they are unable to duplicate the Klonopin wafer. I suspect I will have to try generics and hope to have a better experience with them. I have become fond of being seizure-free over the last 14 months.

I wish you health and happiness, Alivenwell.

[RobinN]

Hi, Robin:
I think the sublingual meds are stronger. Clonazepam is a very powerful medication, at least for me. I take it on an as needed basis to calm continuous complex partial seizure activity in my brain when it occurs. I tried the 1 mg tablet, but it put me to sleep for half a day, so I was prescribed the 0.5 mg tab. My neurologist told me that the orally disintegrating tabs do not require water & they absorb much more quickly into the mucous membranes than the standard tablet.

Ann - Thank you for your information. I did not know they were experimenting with this type of medication for seizures. It does make sense however. I did have one migraine medication that was sublingual, and it worked rather quickly. Unfortunately over time it stopped helping, and thankfully about that time I was introduced to magnesium.

Jill - I do hope you find a solution. I am sure part of your success is your positive thinking. All my best to you.

[Shutterbabe]

Ah, it seems that there is always some hill to climb and I am trying to remain calm as I ascend. Seeking as much information as possible, reaching out to others who might have a suggestion.

All this shall pass? I am determined to stay healthy and will do everything in my power to stay informed, pro-active with my own physicians ( what a concept!) and count my blessings.

You always inspire me. Gracias, amiga.

Abrazos,
Jill

[Wafers]

Hi

I'm in the same situation as you in regards to the Klonopin Wafers. I've been taking Klonopin for 8 years now, the Wafers for 6. I love the Wafers so much more than the Klonopin tablets.

I too have only a few Wafers left. So I guess it's time to try the generic until Roche gets it together. If the generic wafers are whack, then I'll go back to the brand name tablets.

Good luck.

Let's cross our fingers! Maybe they'll get them back on the shelves soon!
You are not alone!
I know both of us will get through this situation!!!

EP

[Shutterbabe]

I am sorry to hear that you are also in a state of the unknown. As you might have read on this thread, I am dismayed at losing a good medication that has controlled my seizures for a long period of time.

I have been in contact with Hoffman-La Roche. One of their senior nurses has become my advocate and a terrific source of information. She actually has been calling me on her own every Monday to keep me informed of the status of this drug. Having someone on the inside, who is privy to immediate news, has soothed me somewhat but does not take away the reality that I have yet to find an effective substitute.

There is no release date yet to bring back "our" Wafers. I will have more news on Monday. I will keep you up to date on this site. Until then, do what you must to maintain your health. My doctor has prescribed the brand name Klonopin tablets to chew at onset of an event. Mercifully, I have not had to use then yet.

Please stay well and check back.

Peace,
Jill