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February 11, 2005

FDA Says Adderall Drug Data Isn't Enough for Recall

Topics: Clinical Pharmacology

Adderal XR (SLI-381) is an  extended release formulation of short-acting Adderall, a racemic mixture of dextro- and levo-isomers of amphetamine salts. Drug-containing microbeads within the SLI-381 capsule give a double-pulsed delivery, similar to that achieved by two equal doses of the short-acting formulation administered 4 hours apart.

While the U.S. Food and Drug Administration isn't taking Adderall XR off the market, yet, it seems that the Canadians are playing it a little safer. If I had a child on this drug I would exercise extreme caution, at least in begining my child on the drug since researchers have noted that PK parameters evidenced substantial intersubject variability (coefficients of variation = 28-56%), and that this Intersubject variability underscores the need for individual dose titration. As is the case with many adverse-events, the juxtaposition of pharmacokinetics with individual case variability can be key to putting such events into a perspective sufficient to making a determination of safety. However, I believe that in all adverse-event situations, health agencies should err on the side of caution rather than image.

``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.

- 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.         

``The cases are not convincing evidence the drug is clearly responsible for these deaths,'' said Robert Temple, director of the FDA's office of medical policy, in an interview.         

The drug, Shire's biggest product, will remain available in the U.S., its largest market, Temple said. House and Senate committees have been probing the FDA's monitoring of drug safety since antidepressants were linked to increased risk of suicide in children and Merck & Co. withdrew its Vioxx painkiller after a company study tied it to heart risks. More...

Posted by Hyscience at February 11, 2005 9:17 AM

Please bloggers give this article wings. My son from my first marriage is on adderall and I ahve been trying for two years to her to see how bam that drug and all adhd drugs are for kids. We do no know the long term effect this will have on kids. Please help by letting your congressman know to stop the drugging of kids!!

Posted by: Pat at February 13, 2005 9:46 AM

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