Valium May Be Going Off The Market!

[Guest EmilyAnne]

I just got off the phone with my vet. I was asking her about using Valium *before* the Grand-Mal hits when Henry shows signs of Grand-Mal coming on very fast. She said the makers of injectable Valium are not making enough profit off it anymore due to humans rarely using Valium anymore, and so therefore Valium may not be available for much longer.

 

When Henry clustered in October, if it were not for Valium, he would have been DEAD. It has always been a comfort to know Valium is available for him when the needa rises, and now they want to take it off the market. Valium has saved SO many dogs in cluster or status.

 

I just cant believe this!

 

Does anybody else know anything about this?

[GreytHoundPoet]

Haven't heard anything about it...but I'll never be able to fly without it!

[Guest EmilyAnne]

I'm really hoping someone will tell me I misunderstood or something. Or at least that there is an equally effective drug out there for immediately halting seizures.

[GreytHoundPoet]

I hope so too!

[carronstar]

Maybe the manufacturer is letting the brand name go but the generic diazepam will still be available?

[Guest EmilyAnne]

I started a topic on this through the EPIL-K9 list. I'll let everyone know what I find out.

 

[Guest KennelMom]

I can't imagine it will go away. Maybe the brand name will, but I think valium is still used in many cases. We keep it on hand it's very useful. It better not go anywhere!

[tydyelady]

EmilyAnne, didn't you say INJECTABLE VALIUM in you original post? That is quite different from the Valium tablets many of us know and love. Since I don't have experience with seizure dogs, I don't know what type of valium you would give the dog before seizing, but Valium tabs are still a huge seller. Injectable valium in humans has probably been replaced by other safer shorter acting drugs. I, for instance, got some IV Valium way back when when I was having a wisdom tooth pulled, and I am quite sure they don't use that any more in those procedures. So I read it, from what you said, as IV only, not the tabs. (Hopefully!!)

[Guest Winterwish]

I haven't heard that or seen that regarding diazepam,but as KennelMom mentioned it could be the makers of Valium which is the brand. That had been a possibility for some time becasue the generic is what's used in hospitals in way,way more amounts then the brand name of Valium,and to much less expense.

Edited February 2, 2009 by Winterwish

[ahicks51]

There are piles of benzodiazepine drugs, of which Valium (diazepam) used to be the most common. I know for a while they were tossing around intranasal (up the nose) lorazepam for use in canines- easier than an injection, and very fast-acting.

 

So- if there are absolutely no other injectable alternatives, maybe there's that.

[Guest EmilyAnne]

There are piles of benzodiazepine drugs, of which Valium (diazepam) used to be the most common. I know for a while they were tossing around intranasal (up the nose) lorazepam for use in canines- easier than an injection, and very fast-acting.

 

So- if there are absolutely no other injectable alternatives, maybe there's that.

I hope so.

 

The vet says this discontinuation, *if* it happens, will apply to Henry as the kind of Valium he gets rectally is the injectable kind. His is liquid form. I know they make it is suppository form too. Hopefully only the liquid kind is being discontinued? Still waiting on replies from EPIL-K9 list to see if anyone else knows about this.

[CaliforniaGreys]

I haven't heard this. I checked the new releases from Roche and not a peep about it.

[Guest EmilyAnne]

I haven't heard this. I checked the new releases from Roche and not a peep about it.

I've been trying to google this, and instead I keep getting links talking about withdrawal symptoms for those addicted to Valium. Not links about withdrawal from the *market*.

 

I'm hoping someone else who has an epi-dog will call their vet and see what they can find out.

[ahicks51]

Wait, what? Huh? Injectable rectal Valium? Do you mean suppositories, or injectable?

 

If the former, it may remain available as generic- at the very least, through compounding pharmacies.

 

Valium used to be the most-prescribed drug in the United States (which says a lot about society, I suppose, as most of that didn't revolve around seizures). I remember distinctly one call with a patient in status epilepticus- he had to be moved from the second floor of his home down a stairwell that was clearly inadequate for doing so- where he didn't stop until he was loaded with diazepam at the hospital.

[Fudge]

Maybe the manufacturer is letting the brand name go but the generic diazepam will still be available?

 

 

I bet that is the answer....diazepam will probably still be available.

[Guest Winterwish]

The need for diastat,which is the diazepam gel used for rectal absorption,will continue as will a company who will make it. Maybe generic,may be a different name,but the need is clear but I'm sure no one will be left without a treatment for status epilepticus.

Edited February 2, 2009 by Winterwish

[Guest EmilyAnne]

Wait, what? Huh? Injectable rectal Valium? Do you mean suppositories, or injectable?

 

If the former, it may remain available as generic- at the very least, through compounding pharmacies.

 

Valium used to be the most-prescribed drug in the United States (which says a lot about society, I suppose, as most of that didn't revolve around seizures). I remember distinctly one call with a patient in status epilepticus- he had to be moved from the second floor of his home down a stairwell that was clearly inadequate for doing so- where he didn't stop until he was loaded with diazepam at the hospital.

Don't worry, I dont stick an actual needle up his butt.

Here's a picture of it~

 

 

Maybe the manufacturer is letting the brand name go but the generic diazepam will still be available?

 

 

I bet that is the answer....diazepam will probably still be available.

So far on the EPIL-K9 list, this is what many people are agreeing on.

 

[LBass]

Wait, what? Huh? Injectable rectal Valium? Do you mean suppositories, or injectable?

 

Liquid diazepam (injectable) is administered to the dogs rectally via a small tube. That is the protocol developed and tested by a veterinary neurologist whose name I can find but do not remember at the moment) and it is used fairly commonly now to control cluster seizures at home. Some people do use diazepam suppositories and have tried nasal administration as well.

 

With any luck, we'll find that the generic will still be available.

 

 

[DaisyDoodle]

I searched this site http://www.fda.gov/cder/ but didn't turn up anything. AJ--maybe you can find something.

 

I found this press release that there is a new agreement for the manufacture of Diastat--which, I believe, is the product you're talking about. It seems like seizure control is a vital use of this form of diazepam; I can't imagine that no one would manufacture it.

 

http://www.reuters.com/article/pressReleas...2008+BW20081024

 

Further Enhances Relationship with GlaxoSmithKline

ALISO VIEJO, Calif.--(Business Wire)--

Valeant Pharmaceuticals (NYSE:VRX) today announced that it has

signed an agreement with GlaxoSmithKline (NYSE:GSK) for the promotion

of Diastat® and Diastat® AcuDial, the first and only

FDA-approved, acute at-home medication for patients two years and

older on stable antiepileptic medications (AEDs) who experience bouts

of increased seizure activity, sometimes called serial or cluster

seizures or breakthrough seizures.

 

Under the terms of the agreement, GSK will exclusively promote

Diastat® and Diastat® AcuDial to U.S. physicians in 2009, with

an option to extend the term by mutual agreement. Valeant will

continue to book sales and will be responsible for ongoing brand

strategy and product development. Financial terms of the agreement

were not disclosed.

 

"We believe this agreement further strengthens the collaboration

in epilepsy between our companies and will help build a strong

platform in advance of the potential launch of retigabine," said J.

Michael Pearson, chairman and chief executive officer. "By utilizing

GSK's larger sales force infrastructure, we can broaden our exposure

to the patients who suffer from breakthrough seizures, and the

physicians who treat them, and potentially help these patients avoid a

trip to the emergency room. In addition, we believe this agreement

will capitalize on the synergies between our two companies, expanding

the promotional support for this important product while lowering

Valeant's overall cost structure."

 

About Valeant

 

Valeant Pharmaceuticals International (NYSE:VRX) is a

multinational specialty pharmaceutical company that develops,

manufactures and markets a broad range of pharmaceutical products

primarily in the areas of neurology and dermatology. More information

about Valeant can be found at www.valeant.com.

 

About DIASTAT

 

Diastat® AcuDial (diazepam rectal gel) is a gel formulation

of diazepam intended for rectal administration in the management of

selected, refractory patients with epilepsy, on stable regimens of

AEDs, who require intermittent use of diazepam to control bouts of

increased seizure activity for patients 2 years and older.

 

In clinical trials with Diastat®, the most frequent side effect

was somnolence (23%). Less frequent adverse events reported were

dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria,

incoordination, asthma, rash, abdominal pain, nervousness and rhinitis

(1%-5%).

 

FORWARD-LOOKING STATEMENTS

 

This press release contains forward-looking statements, including,

but not limited to, statements regarding the company's recently

announced restructuring efforts that are based on management's current

expectations and involve risks and uncertainties, including, but not

limited to, risks and uncertainties relating to capitalizing on the

synergies between Valeant and GSK, lowering the Company's cost

structure, and other risks detailed from time to time in the company's

SEC filings. The company cautions the reader that these factors, as

well as other factors described in its SEC filings, are among the

factors that could cause actual results to differ materially from the

expectations described in the forward-looking statements. The company

also cautions the reader that undue reliance should not be placed on

any of the forward-looking statements, which speak only as of the date

of this press release. The company undertakes no responsibility to

update any of these forward-looking statements to reflect events or

circumstances after the date of this press release or to reflect

actual outcomes.

 

Valeant Pharmaceuticals

Laurie W. Little, 949-461-6002

 

Copyright Business Wire 2008

 

 

+++++++++++++++++++++++++++

 

Also, there was an FDA warning from 2006 that the syinges may have cracks, resulting in delivery of <full dose.

 

 

 

Diazepam Rectal Gel (marketed as Diastat AcuDial) Information

 

FDA ALERT [3/2006]

 

Cracks have been found in the applicator tips of the 10 and 20 mg Diastat AcuDial prefilled syringes. Medicine can leak through the cracks. If medicine leaks, there may not enough medicine to treat a seizure.

 

If you or someone in your care uses Diastat AcuDial, carefully check your pre-filled syringes for cracks. You should check the syringes WITHOUT REMOVING THE CAP. For instructions: visit http://www.diastat.com and click on the “Alert” Box to see photos, or call Valeant Pharmaceuticals at 1-877-361-2719, about how to check for cracks.

 

If you see a crack, use a different syringe. Take all cracked syringes back to the pharmacist and exchange them for new syringes. Cracks can appear over time, so keep checking on your syringes to make sure you have good ones ready to use if needed.

 

If seizures continue after using Diastat, get emergency medical help right away by calling 911.

 

The company that makes Diastat AcuDial prefilled syringes is working to correct the problem, but new syringes will not be available until June or July. Meanwhile, the old prefilled syringes will still be dispensed because there is no other product available to treat sudden increased seizures.

 

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

[Guest lynne893]

Haven't heard anything about it...but I'll never be able to fly without it!

 

DITTO!!

 

[Guest suzye]

So Diazepam is the generic for Valium? I knew they were similar drugs but didn't realize they are essentially the same. A shot of diazepam is the only way she and I were able to sleep the night before we put Jazz to sleep. She was very distressed. We got only 2 hours of sleep the night before (maybe she didn't sleep at all).