Canada Pulls Adderall: Linked to 20 deaths. US FDA Shugs.

[elehhhhna]

FDA Says Adderall Drug Data Isn't Enough for Recall (Update1)
Feb. 10 (Bloomberg) -- U.S. drug safety reports linking an attention deficit drug to 20 deaths aren't enough for the Food and Drug Administration to follow Canada in taking the product off the market, the agency's director of medical policy said today.

Health Canada ordered the withdrawal yesterday of Adderall XR, made by Shire Pharmaceuticals Group Plc, based on its review of adverse-event reports previously given to the U.S. agency by the Basingstoke, England-based company. The drug is prescribed for children and adults with attention deficit hyperactivity disorder.

snip...

FDA Discouraged Withdrawal?

``Information conveyed to my staff suggests that during a recent Adderall meeting, one or more FDA employees requested that the Canadian government refrain from suspending the use of Adderall XR because there was concern that FDA could not handle another `drug safety crisis,''' Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, said today in a letter to acting FDA Commissioner Lester Crawford.



http://www.bloomberg.com/apps/news?pid=71000001&refer=&sid=axaZ7aWJXXys

[Liberal Veteran]

1. Gotta have those priorities straight.

I mean everyone knows that the well-being of the FDA is FAR more important than the health the public.

Although to be honest, I'm not really sure that 20 deaths is all that surprising considering that Adderall is an amphetamine. I think OVER-prescribing of is the more the problem than the drug itself.

Every drug has potential side-effects, some very very serious. When looked at in context, if as the article states, there are over 1 million people taking Adderall regularly and 20 die that represents 0.002% risk. Most people wouldn't blink at those odds, but the bottom line is that we need to examine WHY we have to prescribe so much of these types of drugs including those taking Ritalin and Concerta.

I know that people like to bash the pharmaceutical industry and lord knows they deserve a lot of the criticism they get, but this particular class of drugs has been around for nearly a century and the risks are fairly well established.

[thefloyd]

3. I take adderrall and let me tell

my life is actually normal these days. I was fired from my last job but back in school. Attention Deficit Disorder is real. A.D.D should not be diagnosed in certain cases BUT not all cases. Just because Adderrall is partly made of an ampthetamine. Amphetamine has nothing to do with deaths.

[Liberal Veteran]

6. I don't doubt their usefulness for those who need it.

Adderall is an amphetamine, period (amphetamine and dextroamphetamine to be precise). We used to call it speed when I was growing up, but it's basically the same drug.

Used correctly, these drugs are highly effective for a number of indications including ADD, narcolepsy, and even weight loss, but there is always going to be the small subset of people who don't respond the same way to a drug or people who have an undiagnosed condition (such as heart problems) and get prescribed a stimulant drug that is contraindicated for those with heart problems.

As I said, taken in context, 20 deaths over a 4 year period to the drug out of 1 million taking a medication regularly is a fairly low risk and most likely indicative of another underlying condition that was exacerbated by the drug rather than the drug itself.

[thefloyd]

8. amphetamine is not speed!!!!!

Meth for Methanol amphetamine is speed!!!! Just like sodium choloride (salt) is deadly when the chemicals are split apart. Just because it says amphetamine does not mean it is speed.

[Liberal Veteran]

10. Um, yes amphetamines are speed.

"Speed" most commonly refers to amphetamine sulphate (also known by its trade name, Benzedrine as well as a host of other street names).

Amphetamines were fairly common when I was in high school and we all called it "speed".

There is also dextroamphetamine and methamphetamine (Methedrine or "Meth").

It's ALL known as speed and they are ALL amphetamines.

All amphetamines have similar CNS stimulant effects and all legal amphetamines are Schedule II medications because they have an extremely high potential for abuse.

[thefloyd]

11. Just because they are known as Speed does not make it

speed. These are schedule II medications because there is potential for abuse. Abuse does not mean just addiction, it means these medications may be used in the production of other drugs

[WildClarySage]

5. After reading the article I have to agree that the risks probably aren't

that high. Sounds like the XR version may deliver too high an amphetamine dose for some who have pre-existing conditions? I don't know.

OTOH, it's urgent that people who take prescriptions know exactly what the risks are. I've had doctors prescribe medication for me without disclosing the risks, and had to do the research on them myself, only to determine that I wasn't willing to risk it. Patients must be encouraged to be active participants in their health care, and that doesn't stop at letting pharma run commercials for impotence, incontinence and cholesterol meds.

[Liberal Veteran]

7. I couldn't agree more.

Unfortunately, docs are often left in a bind between not having time to go over medications in detail and concerns of actually scaring the patient from taking a drug that will help their complaint.

I do agree that people need to be aware of the potential side effects of EVERY MEDICATION they take and they should take the time to read the patient handout that usually describes them. Also, they need to take advantage of their pharmacist who is required by law to counsel patients when they prescribe a medication and not just waive the counseling as many do (I do waive the counseling most of the time, but I have been known to ask my pharmacist about specific things).

[chicagiana]

9. Probably double dosers ...

The largest tablet of XR is 20mg. Thats 10mg up front than another 10mg 3-4 hours later.

Those taking Adderrall XR for a "rush" could potentially take multiple tablets. When the second dose starts to kick in, there system will be overwhelmed by the first dose.

I guess everything has it's risks. I used to take straight Adderrall and I abused it because I wasn't very good at using a watch to time dosing. I got used to the "rush" feeling to tell me when I needed the next dose.

XR is better for me because I can just take one in the morning and that gets me through the workday.

[ClintonTyree]

2. We have to give these pharmaceutical companies a chance.....

they're honest, trustworthy companies that would never endanger the lives of anyone. An even if they did, they shouldn't be held accountable. Those frivolous law suits are hurting our economy!

<sarcasm meter off scale>

:puke: :puke: :puke: :puke: You don't know how hard it was to write that.

[hlthe2b]

4. I don't think we want to push FDA to possible overreaction in our efforts

to push reform. Just as with the problems with Cox2 selective inhibitors(VIOX) had people starting to think in lock step about pulling all NSAIDs with Cox2/Cox1 inhibitory effects, including ibuprofen, we risk a display of "ubercautious" regulation that can set back patient health care and quality of life for decades.

All drugs have some risks and there is always the potential for overprescription. No doubt this needs to be globally addressed, but Adderall is already a schedule II controlled drug which does impact that tendency. The unfortunate deaths are proportionately very low for a major drug among a globally large population of users, so I certainly don't draw any immediate conclusions that FDA is wrong in this case.

We stand a real risk of making things worse if we force FDA to reflexively respond to public perception of laxity in their regulation efforts, rather than push for real reform. IMHO