Monday, February 14, 2005

Drugs unsafe in Canada are safe here (and vice versa)?

The FDA doesn't want you to buy prescription drugs in Canada because it can't be assured they are safe.

I guess Canada feels the same way about FDA approved drugs sold in this country. Health Canada has suspended the sale of the ADHD drug Adderall XR because of concerns over 14 deaths in children and six deaths in adults.
Health Canada says that it instructed Shire BioChem Inc., the manufacturer of Adderall XR, to withdraw the drug from the Canadian market. Health Canada is advising patients who currently are being treated with Adderall XR to consult their physician immediately about use of the drug and selecting treatment alternatives.

Health Canada's decision came after 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 (sold in the United States, not in Canada) or Adderall XR (sold in Canada).

These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children and six deaths in adults. There were 12 reports of stroke, two of which occurred in children. None of the reported deaths or strokes occurred in Canada.
(Health Daily)
The US FDA, on the other hand, thinks continued sale is just fine for American consumers. FDA reviewed the same data as Health Canada, but, "based on [its] own knowledge and assessment of the reports. . . felt that no immediate changes were warranted in its labeling or approved use . . . ."

To which, the FDA adds:
Patients using the drug (or parents of children taking it) who have questions should consult their physicians before making any alterations to their therapy . . .
In other words, ask your doctor . . . unless your doctor says it's OK to buy re-imported prescription drugs from Canada.