Health Canada, an agency similar to the Food & Drug Administration, recently decided
to recall
Adderall XR in Canada. Adderall XR is a drug prescribed for attention deficit hyperactivity disorder (ADHD) treatment in both adults and children.
(Note: Updated articles are listed at the
bottom of this page in chronological order)
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The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. However, the FDA has decided not to recall Adderall in the United States. While there is nothing necessarily wrong with this approach since drug agencies worldwide often take very different decisions, things get pretty interesting when more details are read about the controversy.
Shire Pharmaceuticals, the maker of Adderall, is not pleased with the decision and has vowed to file an appeal. The company says that it is confident in the safety and effectiveness of the drug. But now there are reports that the FDA actually put pressure on Health Canada not to recall Adderall. According to Senator Charles Grassley of Iowa, the FDA did not want to recall Adderall since it did not want to deal with another crisis after
Vioxx recall. Does it also mean that FDA will be scared of a
Celebrex/Bextra
recall, and therefore, not recommend this course next week? That is what is scaring Americans who have lost trust in the FDA and its ability to simply act on facts and work to protect the health of American people. |
Health Canada and other drug agencies in most countries are independent agencies and have no ties to pharmaceutical companies unlike the United States where fees collected from drug companies provide funds for the FDA. In the United States, 600 lobbyists from the pharmaceutical industry walk the hallways of Congress and the FDA, and often help draft policies and regulations.
According to Health Canada, the incidence of serious adverse reactions leading to death was higher in ADDERALL and ADDERALL RX combined than in the other drugs of this class. In fact the agency is so concerned about the toxicity of these drugs that it is asking Canadians to not even throw the unused drugs in the garbage or flush it down the toilet since
that may contaminate municipal ground water and become
an environmental hazard.
Health Canada has also asked manufacturers of other related stimulants approved for the treatment of ADHD to provide a thorough review of their worldwide safety data.
A Food and Drug Administration advisory panel has urged
that the strongest possible safety warning (black box) be
issued for these drugs, because of emerging concern that
they may increase the risks of heart attacks, strokes and
sudden death.Related articles in chronological
order: Adderall
XR reinstated in Canada Adderall
XR may soon be available as Daytrana patch form Cylert
(another ADHD drug) recall demanded over safety concerns Ritalin,
a drug similar to Adderall XR, may damage DNA and cause
cancer American
doctors support FDA decision not to recall Adderall Shire
expects Adderall XR recall decision reversal
FDA
must recall Adderall until complete risk analysis is
done Health
Canada suspends Adderall XR sales |
