AUG. 24 12:09 P.M. ET An attention deficit hyperactivity disorder drug that was forced off the market last February by Canadian Health officials is being reinstated, the drug's maker, Shire Pharmaceuticals, announced Wednesday.

Adderall XR will be reinstated on the Canadian market effective this Friday, but it will take a bit longer before the drug is available again across the country, company spokesperson Matt Cabrey said in an interview.

The reversal of the federal regulator's decision comes after a panel of experts -- called a new drug committee -- reviewed the safety data on the drug. Shire triggered the review by in effect appealing Health Canada's decision to remove the drug from the market.


"The NDC (new drug committee) came to the conclusion that there was not enough evidence of an increased harm from Adderall compared to other therapies available," said Health Canada spokesperson Jirina Vlk.

"The benefits of treating ADHD has to be balanced with the known harms of this class of drugs."

Health Canada pulled Adderall XR, a once-a-day treatment for ADHD, off the market on Feb. 9 after learning from the company of 20 cases of sudden death and 12 of stroke in people using the drug. None of those cases occurred in Canada.

Fourteen of the sudden deaths and two of the strokes were in children. A number of the cases involved children with structural heart defects.

The U.S. Food and Drug Administration reviewed the data on the cases last summer and concluded the rate of sudden deaths and strokes in Adderall users wasn't higher than what's called the background rate -- the rate of such events that would be expected to occur in people not taking the drug.

The U.S. regulator agreed with the company that product labels should be modified to warn of the potential problem.

But when Shire approached Health Canada to change its product monograph in this country, the federal regulator responded by pulling the drug.

The announcement was criticized by psychiatrists and patients, many of whom had found the drug more useful for treating their symptoms than other available therapies.

"We expect to have the product available for patients within the next 14 to 21 days and we're now in the process of going through all the appropriate steps to ensure that it's available to physicians and pharmacists," Cabrey said.

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By HELEN BRANSWELL

Thursday, August 25, 2005 Page A13

Canadian Press

TORONTO -- A drug for attention deficit hyperactivity disorder (ADHD) that was forced off the market last February by Health Canada is being reinstated after an expert panel declared it was of no greater risk than other medications for the disorder.

Adderall XR will be reinstated on the Canadian market effective tomorrow, but it will take a bit longer before the drug is available again across the country, said Matt Cabrey, a spokesperson for Shire Pharmaceuticals.

"We expect to have the product available for patients within the next 14 to 21 days, and we're now in the process of going through all the appropriate steps to ensure that it's available to physicians and pharmacists," Mr. Cabrey said.

The drug was ordered off the market after Shire alerted the Canadian drug regulator that it had reports of 20 cases of sudden death and 12 of stroke in people using Adderall or its once-a-day formulation, Adderall XR. (Only the Adderall XR was approved for use in Canada.)

All the adverse events occurred in the United States, where more than 37 million prescriptions for Adderall or Adderall XR have been filled since 1994. The U.S. Food and Drug Administration concluded that the frequency of sudden deaths and strokes wasn't higher than what's called the background rate -- the rate at which such events occur in people not taking the drug.

A Health Canada official yesterday defended the action taken last February, saying given the severe nature of the adverse events, prudence was required. "We were talking about potential deaths in children, therefore we felt that it was the most appropriate action at that time," said Dr. Marc Berthiaume, director of Health Canada's marketed pharmaceuticals division.

Word that Adderall XR will soon be available again was greeted with relief by patients who had responded well to the drug, and their doctors. Many were highly critical of Health Canada's initial, unexpected decision to withdraw the medication.

"It's been hell," Dr. Umesh Jain, a psychiatrist at the Centre for Addiction and Mental Health in Toronto who specializes in treating patients with ADHD, said of the upheaval caused by Health Canada's decision. "As a researcher who deals with ADHD and impulsive people, my first instinct was: 'We should medicate Health Canada, for God's sake. What's wrong with these people? Where were their heads?' "

One of his patients, Johnny Epstein, said he was thrown into a crisis when the decision to disallow sales was made. "I had a panic the way I would imagine a crack addict would have a panic if he just heard his dealer had gotten busted. It was: 'What am I going to do now?' " said Mr. Epstein, 36, a Toronto-based computer-software developer.

"To me, this is a life blood that I've just been denied."

Mr. Epstein managed to stay on the drug by flying to the United States to see a specialist who gave him a prescription he filled in the United States. He estimates he spent between $3,000 and $4,000 to obtain the medication in the intervening months.

"To be completely honest . . . I would have gone to any place on Earth to get this medicine. If they had told me I needed to fly to Slovakia to get it, I would have done that," he said.

The drug's roller-coaster ride began last summer, when Shire approached the FDA seeking approval to market Adderall to adults, as well as children. It was granted that right, and provided the U.S. agency with safety data that showed the small number of serious adverse events in people using the medication. The manufacturer and the FDA agreed the drug's packaging should be changed to warn it should not be used by people with structural heart abnormalities. Most of the people who suffered the adverse events had these heart defects.

In November, Shire approached Health Canada asking to make a similar change to the product monograph for Adderall XR. The agency's decision to withdraw the drug from the market was based on the safety data submitted with that request.

"The adverse events that were identified are very rare, but they are also catastrophic," the then-director-general of the therapeutic products directorate, Dr. Robert Peterson, said at the time.

Shire effectively appealed the decision, asking that an expert panel -- called a "new drug committee" under the applicable Health Canada regulations -- be set up to review the evidence and the decision.

"The NDC came to the conclusion that there was not enough evidence of an increased harm from Adderall, compared to other therapies available," said Health Canada spokesperson Jirina Vlk.

Mr. Cabrey said Adderall XR's product monograph will be changed to include the warning that the U.S. regulator approved last summer.


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