Adderall XR was taken off the Canadian market last Wednesday. Health Canada cited 20 reports of sudden death in patients taking any form of Adderall in their decision.
The drug is prescribed to patients diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). Nationally, five million children and three million adults take the drug, including a large number of students.
The Food and Drug Administration has approved the drug for use in the United States and has no immediate plans to change the drugs status in the American market, FDA spokesperson Brad Stone said.
"Whenever another health agency takes an action or issues a statement or a study on a drug that we regulate, we certainly look at it very carefully," Stone said. "At this time we don't think that there is any change warranted."
Canada always has had a more restrictive attitude towards Adderall than the United States. It approved the drug's extended release version (Adderall XR) in January 2004, and the instant release version was never sold in Canada. The FDA approved Adderall in 1996, and Adderall XR in 2001.
Shire, the drug's manufacturer, wanted to expand its approval to include treatment of adults. In August 2004, in seeking regulatory approval for that decision, the FDA added a warning to the drug indications discouraging people with pre-existing structural cardiac abnormalities from taking the drug. That review and the data associated with it led to Health Canada's decision.
"Health Canada's decision comes as a result of a thorough review of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death in patients taking either Adderall or Adderall XR," Health Canada said in a press release issued Feb. 9. "These deaths were not associated with overdose, misuse or abuse."
Several factors may have led to the deaths cited in the Canadian decision, including pre-existing heart conditions and sudden death that occurs for other reasons.
"The majority, 12 or 13 [of the deaths] had some underlying structural or rhythm cardiac problem," said Dr. Larry Diller, a behavioral-developmental psychiatrist in Walnut Creek, Ca. who prescribes Adderall and is the author of "Running on Ritalin" and "Should I Medicate My Child?".
Therefore, many doctors recommend not varying from the prescribed regimen.
"It wouldn't change the treatment of the 99 percent of people without a pre-existing condition," Diller said. "It does change the existential nature of taking this medicine now. Up untill now I've been able to say that nobody has run the risk of dying for ADHD."
The FDA, Diller and Shire stress that the risk of sudden death from taking Adderall is minimal when done so under the supervision of a physician.
Abuse or misuse of the drug, an issue highlighted in a February 2004 Cavalier Daily article about Adderall abuse on Grounds, can be dangerous.
"In the community it's used way too often without the appreciation of why it's a class II [DEA controlled] drug," said Dr. James F. Dee, an Alexandria psychiatrist who specializes in psychopharmacology. "A lot of people are self-diagnosing themselves with ADD and ADHD and seeking treatment from physicians with Adderall. It's a highly abusable agent."
One of the biggest advantages of the extended release version, Shire contended, is the limitations it places on such abuse.
"It's less likely that the medication will leave the home, dorm room, fraternity or sorority house, or apartment of the college student," Shire spokesman Matt Cabrey said. "This means that there is less of a chance of Adderall XR being abused by patients who do not have a prescription for it."
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