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Adderall XR pulled in Canada", default", stays in U.S.

Adderall XR, a widely used drug for attention deficit hyperactivity, will stay on sale in the United States even though Canada pulled it off the market.

Late Wednesday after linking it to 20 students deaths and a dozen strokes.

M. ALEXANDER OTTO; The News Tribune
Last updated: February 11th, 2005 02:40 AM

Adderall XR, a widely used drug for attention deficit hyperactivity disorder, will stay on sale in the United States even though Canada pulled it off the market late Wednesday after linking it to 20 sudden deaths and a dozen strokes. Fourteen of the deaths and two of the 12 strokes were in children.

The adverse reactions were not associated with overdose, misuse or abuse of the drug, Canadian regulators said.

The U.S. Food and Drug Administration issued a public health advisory to alert providers to the withdrawal.

But the agency also said it had evaluated the same reports as Canadian regulators and didn’t think the data warranted pulling the drug from the U.S. market.

In a statement, the FDA said it “does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse event reports and FDA’s own knowledge and assessment of the reports received by the agency.”

About 700,000 people take Adderall XR – the “XR” stands for extended release – in the United States.

About 300,000 use the older immediate-release version, said a spokesman for Shire Pharmaceuticals Group, the United Kingdom company that makes the drugs and stands by their safety.

The small number of deaths reported among so many users is one reason the FDA is not following Canada’s lead. The agency also is not convinced that Adderall is responsible for the deaths.

The FDA told users of either form of the drug and parents of children who take the pills to “consult their physicians before making any alterations to their therapy.”

At this point, the Canadian withdrawal is a tip-off to patients and providers that there could be a major problem with yet another widely used drug at a time when Vioxx, Celebrex and other blockbusters have been linked to significant dangers.

The withdrawal in Canada has local providers worried.

“We are taking this seriously and are looking to notify our clients and bring them in for evaluation,” said Po Karczewski, a nurse practitioner with Greater Lakes Mental HealthCare in Lakewood.

Karczewski performs psychiatric medication evaluations and prescribes Adderall and other drugs.

Adderall, a stimulant, is known to be dangerous in people with heart problems. Labels warn that those patients should not get the treatment.

But what is worrisome to Karczewski and others is that the drug is now linked to deaths even when no heart problems seemed to exist.

Typically, once people are stable on Adderall, they often are not seen again for three or so months.

Greater Lakes has decided to bring people in early to “make sure we are up to date on cardiac issues,” Karczewski said.

The Associated Press and Bloomberg News contributed to this report.

M. Alexander Otto: 253-597-8616

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