View Full Version : 2009 FDA Recall on Dextroamphetamines


ADXP
08-19-10, 05:15 PM
There is a recall on TEVA Barr Dextroamphetamines.

Check this link:

http://www.lawyersandsettlements.com/case/nationwide-recall-of-dextroamphetamine-amphetamine.html

ADHD stimulants linked to sudden death in children

http://www.lawyersandsettlements.com/case/ritalin-side-effects-methylphenidate.html

A useful website for all kinds of class action lawsuits filed, filing & ongoing...

http://www.lawyersandsettlements.com/emerging-issues/drugs-medical-issues/

addamsd
08-19-10, 05:27 PM
Someone who is more into statistics might care to chime in on the 2nd article, but it doesn't make much sense to compare 564 to 564. I'm also not sure if either of those groups are statistically significant. Gather as much data as you can from each group (I'm thinking you can find more than 564) and then calculate overall percentages.

stan_a_rooch
08-19-10, 05:28 PM
The article was dated 2009, and a search for more recent recall info doesn't exist. It does seem like a pretty useful website though...

As for the statistics, the info presented is pretty vague. There is probably statistical significance to those numbers, but I am not quite sure they are being used correctly. If I had a say in the study, which I clearly don't, I think it would make more sense to sample a broader control group as opposed to just children who died in car crashes. One way to do it would be to take a few categories regarding children and death, say car crashes, illness related, non-motor vehicle accident related etc. From those groups, pull samples of n=564 (just because that's what they used, to truly figure it out, you would need to know the total population of each subset) for a total of n= the total number of non-stimulant death children. From this total, using the three groups I listed earlier, that would give us a total of 1692 kids, which could further be randomized and whittled down to a control of n=564. All the group they used tells you is that kids who happened to die in car crashes were predominantly non-stimulant users. I would take an educated guess and say that if you wound up with a true random subset of child deaths, there would be a fair few more children on stimulants in that control.

I need to go hug my 2 year old. All this talk of child death is making me sad.

salleh
08-19-10, 05:34 PM
jeesh , you nearly gave me a heart attack ......that recall was a whole year ago....I thought ...I'm a gonner, my dexys not avaiable ?? NNOOOOOO....

but it was for the 20 mg tabs anyway ....

and about dex and kids, I didn't even know they made a 20 mg tablet, and I take 90mg a day .....


I can't imagine a doc prescribing a child a 20 mg. tablet ......sounds fishy to me

Lunacie
08-19-10, 05:44 PM
There is a recall on TEVA Barr Dextroamphetamines.

Check this link:

http://www.lawyersandsettlements.com/case/nationwide-recall-of-dextroamphetamine-amphetamine.html

ADHD stimulants linked to sudden death in children

http://www.lawyersandsettlements.com/case/ritalin-side-effects-methylphenidate.html

A useful website for all kinds of class action lawsuits filed, filing & ongoing...

http://www.lawyersandsettlements.com/emerging-issues/drugs-medical-issues/

I'm going to make the assumption that you honestly meant to be helpful by sharing some information, but I have to wonder if you actually read the articles yourself before posting the links?

The second one, the one about deaths in children, clearly states that the FDA doesn't believe the study provides definite proof of any danger to children taking this medication beyond what has already been shown. There is a danger in taking any medication, even over-the-counter meds, eh?

I don't think this thread serves any purpose beyond scaring the crap out of parents and others who use this medication when it really looks to me like a scare tactic from the lawyers who are looking for a chance to file a class action lawsuit based on one small study. Shame on the lawyers. I'm going to ask the mods to close this thread before some parent stops giving their child a needed medication or someone stops taking the medication themselves when there isn't a good reason to do so.

stan_a_rooch
08-19-10, 05:56 PM
I don't think this thread serves any purpose beyond scaring the crap out of parents and others who use this medication when it really looks to me like a scare tactic from the lawyers who are looking for a chance to file a class action lawsuit based on one small study. Shame on the lawyers. I'm going to ask the mods to close this thread before some parent stops giving their child a needed medication or someone stops taking the medication themselves when there isn't a good reason to do so.

The thing that kills me is that on those sites there is rarely a link to the actual paper. Sure, some of that is most folks would start to read the deep lingo in the field and have their head explode. But I almost guarantee they are just looking to whip up a fury amongst parents of ADHD children.

I really feel bad for in that situation for the parents and the children because they are placed between a rock and a hard place. The parents feel that they have to choose between the likelihood of the death of their child or an uncontrollable kid. The parents who are scared enough to alter the child's med routine are completely screwing with their brain chemistry, and tearing apart the delicate fabric of that kids personal life.

Should someone god forbid lose a child, and these leeches actually pull together a class action suit, In the end, the parents will only receive minimal restitution for their loss. But hey, the lawyer makes a ton of money, so who cares, right?

Trooper Keith
08-19-10, 06:01 PM
Something that happened a year ago.

Unrelated article of dubious merit.

Thread rules, voted 5 stars.

meridian
08-19-10, 06:01 PM
The recall is from August 18, 2009 NOT from yesterday (Aug 18, 2010 for you who are coming here from the future!)

AUG-18-09: Nationwide recall of Dextroamphetamine/Amphetamine 20mg by Barr Laboratories [FDA: RECALL OF DEXTROAMPHETAMINE/AMPHETAMINE 20 MG BY BARR]

Possum
08-19-10, 06:47 PM
LOL @ Meridian!

Possum
08-19-10, 06:57 PM
OK, I went back and read the second link. The article itself states:

Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children."

And the article was posted on a slimey trial lawyer site, trolling for bucks from big pharma.

The drug cylert was withdrawn a few years back for similar flimsy reasons. It was a great dis-service to the thousands of people who were greatly helped by it - one of whom was me.

Nuff said. This is a non-topic.

Trooper Keith
08-19-10, 08:07 PM
Ehhhh, pemoline was known to cause I believe renal failure in the long run, I don't think yanking Cylert was that bad a move. As I understand it though the USAF still uses it as a "go-pill."

Possum
08-19-10, 09:36 PM
Ehhhh, pemoline was known to cause I believe renal failure in the long run, I don't think yanking Cylert was that bad a move. As I understand it though the USAF still uses it as a "go-pill."

Actually, it caused liver problems in a very small percent of users. To be on the safe side my doctor did a blood test every six months or so. IMO big pharma is so intimidated by the bar association that access to very good and useful drugs has been adversely impacted.

Trooper Keith
08-19-10, 09:41 PM
I'll agree with that. The regular blood tests should have been sufficient. And you're right, it caused hepatic failure in a few people, not renal failure. I remembered poorly, it's been a long time since I've even thought about pemoline. Like I said, I think the US military still uses it as a go-pill, so there's that.

meridian
08-19-10, 09:41 PM
I am constantly amazed at how educated you guys all are about this stuff! I know so little!

stan_a_rooch
08-19-10, 09:43 PM
IMO big pharma is so intimidated by the bar association that access to very good and useful drugs has been adversely impacted.

The other problem with big pharma (and this isn't a post advocating up or down on marijuana legalization) is that they cannot legally patent chemicals that come directly from plants, so they refuse (to some degree) to conduct outright testing. The FDA won't conduct testing either, partly because they are stretched thin, but I wouldn't be shocked if big pharma pressures them. So herbs get regulated to the shelves at health food stores, and are found with warnings stating that the FDA didn't even bother to look at the product, and they have no clue what it does.

Frankly, who knows what kind of miracle cures or fixes we are missing out on.

ADXP
08-20-10, 10:29 AM
To some of you who may find this post disturbing,
I want you to know that
that is not meant to be that way.
I think it through before posting it.

And here is what my thoughts are:

It was a huge debate in my head
when I was making the decision.
I was debating whether to post it or not.
And I decided to becoz I believed that I should take it seriously.
What if there is something valid about it?
What if something happens to others &
I have this piece of information?
How I am going to live knowing
that I have a very important
information with me & I didn't tell anyone.

My take on life these days is to be
cautious & sometimes
I can assume the worst scenario which what
was missing before my diagnosis.
I am acting to be on the safe side &
for the best interest of everyone.
Maybe it doesn't appear or came out that way
but that is where my whole intention is.

meridian
08-20-10, 11:17 AM
To some of you who may find this post disturbing,
I want you to know that
that is not meant to be that way.
I think it through before posting it.

And here is what my thoughts are:

It was a huge debate in my head
when I was making the decision.
I was debating whether to post it or not.
And I decided to becoz I believed that I should take it seriously.
What if there is something valid about it?
What if something happens to others &
I have this piece of information?
How I am going to live knowing
that I have a very important
information with me & I didn't tell anyone.

My take on life these days is to be
cautious & sometimes
I can assume the worst scenario which what
was missing before my diagnosis.
I am acting to be on the safe side &
for the best interest of everyone.
Maybe it doesn't appear or came out that way
but that is where my whole intention is.

It's fine that you posted it. I am glad to know because I take the generic Adderall made by TEVA Barr and so it is important info for me.

The problem I and some other members had with the info was this

There is a recall on TEVA Barr Dextroamphetamines.


With the info being a year old, it would have been better to say there was a recall last year for the sake of accuracy and not getting people excited today about something that happened a year ago.

The other links to somewhat "questionable" attorneys who are looking for a big class action suit and to the again old info about sudden death in a very small number of children might be view by some as alarmist "scare" tactics because groups like Scientologists abuse the data for the sake of their own agenda that mental illness is a myth.

So thanks for the info, I did not know about last year's recall. And don't worry too much about it. You did what you thought was responsible and right and that's a good thing!

But please do check the date of the material and specify it so as not to alarm people unduly.

watts
08-20-10, 01:16 PM
This recall was for generic adderall 20mg tablets. As stated earlier it was last year (August 09) and due to increased amounts of active ingredient.

The title of this thread is innaccurate, misleading, and should be closed IMO.

Thanks

salleh
08-20-10, 01:32 PM
You know., this is a prime case of where rep points and how long the person has been around makes a difference to my reaction.....

ADXP has been around for quite some times and has done a respectable amount posting .....QED..... not a troll.......

and at the time of the post, it didn't even occur to me that they might be trying to stir up trouble......and not because I missed that point, but because I didn't think or feel it was there....


so I am glad they came back and explained why they posted this thread, and show that their heart was in the right place even if the info actually is more harmful than helpful ......( I am speaking of the lawyers site here, when I tried to read it , it seemed so full of gobbledy gook, that I just gave up )


....we can all make honest mistakes about some type of info we come across, and being the social animals that we are around here, not to mention that there is a lot of caring here, we want to help each other.....so thanks ADXP for trying .....


but my main point is that people didn't jump down their throat I betcha , is because we could see that ADXP isn't a troll.....


now, had this been posted by a newbie of less than 10 postings .....that is another story altogether .....


Jess sayin......

salleh
08-20-10, 01:33 PM
hee hee hee ....I got to say QED for the second time this year !!!......

stan_a_rooch
08-20-10, 11:05 PM
Thanks for the insight ADXP.

tigert
08-25-10, 08:10 AM
Ironically, I just refilled my dex prescription yesterday (10mg tablets) and got a batch that seems to be quite a bit more potent than normal.

The tablets look different also.. they have large-ish white specs which gives them a grainy appearance rather than the normal tablets which have a more uniform color.

Maybe people wouldn't complain about the Barr dex so much if they were all like this batch ;)

Trooper Keith
08-25-10, 01:24 PM
hee hee hee ....I got to say QED for the second time this year !!!......

You used it slightly incorrectly though. "QED" is used at the end of logical arguments to formally end them. It stands for "quod erat demonstrandum," "and thus it is proved." The proper use in this case would be:

P1: ADXP has been around for a long time and has positive rep
P2: No person who has been around for a long time and has positive rep is a troll.
:. Therefore, ADXP is not a troll.

QED.

salleh
08-25-10, 01:34 PM
eh... close enough for bluegrass.....