RESEARCH..Canadian withdrawal of Adderall XR

[ttjmom]

After the recent withdrawal of Adderall XR many have questioned the use of this medicine and what lead to the action taken by the Health office in Canada.


(1) Health Canada ordered the withdrawal of Adderall XR after Shire (the U.K.'s third-biggest drugmaker,) provided information about 20 sudden deaths in patients taking the treatment for attention deficit hyperactivity disorder (ADHD).
Shire said it disagreed with the Health Canada findings, and the U.S. Food and Drug Administration (FDA) said in a statement it did not feel the need to change its stance on the medicine.
Shire said it "strongly disagreed" with Health Canada's findings and that, based on the same data, the FDA had decided only to modify instructions for use of Adderall XR to stress it should not be used in children or adults with heart defects.
"We continue to be confident in the safety and efficacy of Adderall XR," said spokesman Matt Cabrey. He said about 11,000 people were prescribed Adderall XR in Canada and about 700,000 in the United States.
Health Canada said in a statement: "We are advising patients who are currently being treated with Adderall XR to consult their physician immediately about use of the drug and selecting treatment alternatives."

(2) Excerpts from Richard M. Sarles, M.D. AACAP President’s Message from the American Academy of Child and Adolescent Psychiatry

As with previous announcements regarding the use of medications in treating children and adolescents with mental illnesses, AACAP members are advised to:
Include a thorough psychiatric and medical history in the context of a comprehensive evaluation when a child presents with symptoms for ADHD or any other disorder,

Continue your practices as before without immediate changes based on the FDA's report stating that 12 youths experiencing sudden unexplained death (population rate for the SUDs is 1/100,000) is too low a rate to determine a causal link between the drug and the deaths,

Describe and discuss with parents/guardians and with the child or adolescent patient the risks and benefits of any treatment, including treatment with medication, and

Monitor the patient on a schedule that reflects his or her needs and medical history.
The AACAP will be providing additional information on this new FDA statement in the future. The FDA and Canadian statements can be accessed from the FDA website, www.fda.gov. Additional information on children’s psychotropic medications is available on the AACAP website, www.aacap.org, and www.parentsmedguide.com.


(1) http://www.timesonline.co.uk/article...478421,00.html

(2) http://www.adderallxr.com/default.asp?cat=18&aid=732

[Chadwick]

I think the withdrawal of Adderall XR from approval of use in Canada will likely be reversed, at some point in the near to intermediate-term future.

[RhapsodyInBlue]

Originally Posted by Chadwick

I think the withdrawal of Adderall XR from approval of use in Canada will likely be reversed, at some point in the near to intermediate-term future.

Chad, what is it that makes you appear to be so certain of this? The relatively low incidents of deaths? Or gut instinct? Do you, personally, think children should be on the XR? Naturally, you need not answer

[Chadwick]

Just basing my opinion off of Greg's comments. Seek his out, I think they are reasonable and rational.

[RhapsodyInBlue]

Thank you