WHY DON'T BERNARD LORD STOP THE KILLING OF OUR CHILDREN????

adderall_xr, originally uploaded by Oldmaison.

Health Canada to boost warnings on ADHD drugs
Last Updated Wed, 22 Mar 2006 16:34:22 EST
CBC News



Health Canada will add tougher warnings to the labels of Ritalin, Adderall, Concerta and similar drugs used to treat Attention Deficit Hyperactive Disorder, CBC News has learned.

Two million prescriptions for the stimulants, which increase blood pressure and speed up the pulse, were written in Canada in 2005. Use of the drugs is increasing.
Health Canada briefly pulled the ADHD drug Adderall XR from the market last year.



Health Canada plans to add tougher warnings to the stimulants in April that caution people with a family history of heart problems, patients taking another stimulant and those who engage in strenuous physical activities.

The U.S. Food and Drug Administration (FDA) is also considering adding its strongest possible warning to the medications.



The strengthened warnings come after regulators received reports of 25 sudden deaths in American youngsters, as well as cases of heart attacks, strokes and psychosis among children and adults on the drugs.

'I want the physician's hand to tremble a little bit'



The chances of the drugs causing sudden death is rare, about one in 100,000 for children, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic in Ohio and a consultant on an FDA advisory panel that recommended the warning.

Families and doctors need to be alerted to the risks, Nissen said.

"I want the physician's hand to tremble a little bit before they write the prescription for the drug."

Benefits often outweigh risks, ADHD expert says



Aside from Health Canada's stronger warnings, the department also cautions people with any heart risk factors to be screened before taking the drug.

But Dr. Margaret Weiss, head of British Columbia's ADHD program, says doctors already check for potential heart problems by requesting a complete physical exam and cardiac history before prescribing the drugs.



She said ADHD tends to be undertreated and pointed out that the drugs have been used safely to treat the illness in millions of people.

"You're looking at the risk of a potential adverse event against the known risk from a very severe disorder," Weiss said.

* FROM FEB. 10, 2005: Health Canada withdraws ADHD drug

She added that the benefits may outweigh the possible dangers for some children.

Nissen agreed. He is also calling for a patient guide that spells out the risks.



'It's definitely been a beneficial medicine for us'

Sandra LeBlanc, who has two sons with ADHD on Ritalin, said yearly physical exams over more than a decade haven't showed any ill effects.

"It's definitely been a beneficial medicine for us," said LeBlanc, whose family lives in Charlottetown. "It's really improved the family life."



Regulators continue to look for possible side-effects from the drugs, including psychiatric problems.

Headlines: Health & Science

========================================

Health Canada withdraws ADHD drug
Last Updated Fri, 11 Feb 2005 14:40:14 EST
CBC News

OTTAWA - A drug to treat attention deficit disorder is being pulled off the market by Canadian regulators, who are reviewing the safety of similar drugs such as Ritalin.

The drug, called Adderall XR, has been linked to 20 sudden deaths, including 14 among children, as well as a dozen strokes, Health Canada said. Children suffered two of the strokes.



None of the deaths happened in Canada, and none were the result of abuse, misuse or overdose of the amphetamine.

The once-a-day Adderall XR or extended release formula was approved for use in Canada in January 2004. The capsules can be opened to sprinkle the drug on food.

Patients who were prescribed the drug or their parents should consult their doctor immediately and return any capsules to a pharmacy, Health Canada advises on its website.



Health Canada is asking makers of related stimulants for ADHD, including Ritalin, to provide an update of worldwide safety data for the department to review. The department expects to complete the review of ADHD drugs in a month or more.

Ritalin is used by tens of thousands of Canadian children with ADHD and has been prescribed for decades. The three other ADHD drugs under review are Concerta, Dexadrine and Attenade.



"Obviously this is going to affect how everybody views all stimulants until we get better data," said Dr. Wendy Roberts, a developmental pediatrician at Toronto's Hospital for Sick Children.

* FROM MAY 26, 2003: Generic drugs can look like original: Philadelphia court



Shire Pharmaceuticals Group PLC makes Adderall XR, as well as an immediate-release version of the drug that is sold in the U.S. but isn't approved in Canada.

Safety review
Shire said it is complying with Health Canada's order but the company stands behind the safety of the product, which remains on the market in the U.S.


Dr. Umesh Jain

When the U.S. Food and Drug Administration looked at Shire's safety data, the regulator opted to put a warning label on the drug, saying it should not be used by patients whose hearts have structural abnormalities.



On the other hand, Health Canada concluded a warning label is inadequate, given the deaths were sudden and the cause unknown, said Dr. Robert Peterson, director general of the department's therapeutic products directorate.

Some doctors who treat ADHD say the directorate acted prematurely in failing to consult with physicians before pulling the drug.

"We have a crisis on our hands, with frantic patients and doctors scrambling to decide what to do with this decision," said Dr. Umesh Jain, a child psychiatrist at the Centre for Addiction and Mental Health in Toronto.



About 11,000 Canadians take Adderall XR, mostly children. The drug accounts for $10 million in Canadian sales for Shire.