Friday, January 11, 2008

FDA black box warning on Adderall XR

Hmm this is comforting to think about, and what determines it getting pulled from the shelf. I mean im sure there are many things but if they pull all these thats gonna leave alot of people hurting. Unsure of date of this...

FDA Black Box Warning Labels on ADHD Medications
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After much debate the following medications carry the "black box warnings" on the labels of the bottles. These are the strongest warnings that the FDA requires, a step away from pulling the medications.

Adderall Tablets (mixed salts of a single entity amphetamine product)
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
Concerta (methylphenidate hydrochloride) Extended-Release Tablets
Daytrana (methylphenidate) Transdermal System
Desoxyn (methamphetamine hydrochloride) Tablets Label (will be updated soon)
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
Focalin (dexmethylphenidate hydrochloride) Tablets
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
Methylin (methylphenidate hydrochloride) Oral Solution
Methylin (methylphenidate hydrochloride) Chewable Tablets
Ritalin (methylphenidate hydrochloride) Tablets
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
Strattera (atomoxetine hydrochloride) Capsules

Warnings for Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of a Single Entity Amphetamine Products
Adderall, Adderall XR, Desoxyn, and Dexedrine (SR)
High abuse/diversion potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
Drug dependence: Administration of amphetmaines for prolonged periods of time may lead to drug dependence and must be avoided.
Serious Adverse Events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events

3 comments:

Angel The Alien said...

I'm on Adderall and I haven't felt any dependency feelings on it. Actually my depression medicine makes me sick every time I forget to take it, but my Adderall doesn't do much. I guess people using it for recreation are more likely to get addicted!

Anonymous said...

Adderall is fine leave it alone! Running raises my heart rate , should we issue a black box warning for anyone who exercises and tell them that they shouldn't?

Ryder said...

I have nothing against adderall and in fact was on it for a long time. I am now on ritalin and very much prefer my adderall. I just thought it was interesting because that was the first thing like that I had seen so I thought it would be interesting to post. I do believe this warning is more or less geared toward the dangerous possibilities it holds for those who have unknown heart or other issues that may interact with it.

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