Globe and Mail Saturday
February 12, 2005
Health Canada has stripped a pharmaceutical company of the right to sell a popular drug used for the treatment of hyperactive children in Canada after talks about withdrawing the medication voluntarily broke down.The highly unusual move -- market authorization has not been withdrawn from any of the 5,000 prescription drugs on the Canadian market since 1999 -- came after Shire Biochem Inc. revealed that at least 20 people taking Adderall XR had died suddenly, and 12 others suffered debilitating strokes. All the deaths and strokes were in the United States. Most involved children who died of stroke, which occurs when a blood vessel to the brain is blocked by a blood clot or bursts, cutting off oxygen to the brain.
After a review of the drug's safety data, Health Canada asked Shire at about 5 p.m. Wednesday to voluntarily withdraw the drug, said company spokesperson, Matt Cabrey. Shire officials refused, reiterating their belief Adderall XR was a safe therapy.
Within about an hour, the department told the company it was suspending sales of the drug used in the treatment of attention deficit hyperactivity disorder (ADHD) indefinitely, and issued a news release to that effect Wednesday evening.
"Adverse events are very rare but they are also catastrophic," Dr. Robert Peterson, director general of the therapeutic products directorate at Health Canada, said yesterday in explaining the move.
He said the benefits of the drug, improving attention span, had to be balanced against the risk, possible death. Given currently available information and the fact that there are many other ADHD drugs on the market, the continued sale of Adderall XR could not be justified, he said.
Dr. Peterson said Health Canada is unclear why so many children taking the drug died suddenly, but decided to err on the side of caution. The Health Department has also asked all the makers of similar drugs to submit updated safety information, which will be reviewed.
The action, however, angered many clinicians and patients, and even the Food and Drug Administration, the U.S. regulator, distanced itself from the move. The drug's maker, for its part, is threatening legal action.
Pam Eisen, a Toronto-area mother of a severe ADHD sufferer, said she is troubled and unsure what she will do if the 14-year-old can no longer get Adderall. "My son has gone from not being interested in school at all, and being really disruptive, to being one of the most-improved students."
Ms. Eisen said David was taking Ritalin for five years but it was never as effective as Adderall. "I would definitely keep using it if I could because nothing else has worked."
Dr. Umesh Jain, a child and adolescent psychiatrist and administrator of the Canadian ADD Resource Alliance, also had high praise for Adderall XR.
He said the once-a-day, long-lasting formulation is of great benefit to patients, particularly to children.
Dr. Jain said while he appreciates that Health Canada is concerned with patient safety, he is angry at the way the decision was made to withdraw authorization to sell the drug in Canada -- suddenly and without warning.
"What are my patients supposed to do now?" he wondered. "I have to slot them all in and find alternative treatments. But what happens if they don't have supply in the meantime? Do they have to go through withdrawal?"
Dr. Jain, who is also a researcher at the Centre for Addiction and Mental Health in Toronto, said he takes issue with Health Canada's interpretation of the safety data. He said among the 20 Adderall XR users who died suddenly, the vast majority had prior heart problems, and there is no evidence that children or adults with healthy hearts are at risk. "If you take out the kids with prior cardiac difficulty, the difference in risk is negligible," Dr. Jain said.
The U.S. FDA said yesterday, that unlike Canada, it will allow sales of the drug to continue. A spokesman said yesterday that there is no convincing evidence the Adderall is "clearly responsible" for these deaths.
There were 64,098 prescriptions dispensed for Adderall in Canada in 2004 (meaning that about 11,000 people are taking the drug), according to IMS Health Canada, a private company that tracks prescription-drug trends. Sales totalled $6.6-million in Adderall's first year on the market.
Adderall makes up only 4 per cent of total prescriptions for analeptics -- drugs used to treat ADHD and similar conditions. The great majority of children and adults with the condition take methylphenidate -- best known by its brand name Ritalin, though there are many generic forms. There were 1.7 million prescriptions dispensed for analeptics last year, with sales exceeding $87.5-million.
Health Canada has advised patients taking Adderall XR to consult a physician about alternative treatment and to return any unused drugs to a pharmacy.
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LOS ANGELES - The U.S. Food and Drug Administration has warned that people with heart problems should not take the hyperactivity drug Adderall, and studies may be done to see if it raises risk in others, a top official at the agency said on Thursday.
The FDA is aware that children have died after taking the drug, but cannot tell whether the rate is higher than it is in the general population, said Dr. Robert Temple, director of the FDA’s Office of Medical Policy.
“There is a background rate of sudden death in children,” he said.
Canadian regulators on Thursday suspended sales of Adderall XR, a drug for attention deficit hyperactivity disorder (ADHD) made by Britain’s Shire Pharmaceuticals Group Plc, after the company said 20 people taking the drug, including 12 children, had suddenly died between 1999 and 2003.
The U.S. FDA last September ordered Shire to add a warning to the drug’s label indicating that it should not be given to people with structural heart defects, but has not taken further action.
“We were aware of these reports of sudden deaths ... what we concluded was that five of the cases involved people with evidence of heart disease,” Temple said.
Another case involved a child with Type 1 diabetes, a couple of the children had toxic levels of the drug in their blood and one child was exercised in the heat “until he was half dead from that,” the FDA official said.
Benefits vs.
risks
Over the same time period, the FDA’s reporting system logged seven
sudden deaths of children taking other ADHD stimulants -- Concerta, sold by
Johnson & Johnson and Ritalin, made by Novartis AG.
All three drugs are amphetamines.
“The benefits of ADHD medicines are clear and the risks of undertreating patients are also clear,” said Dr. Lenard Adler, director of the ADHD program at New York University School of Medicine. Untreated patients are more prone to be involved in automobile accidents, become divorced, to be unemployed, to smoke and to have substance abuse problems, he said.
Many patients who have previously had electrocardiograms will know whether they have cardiac problems. “For other patients, you have to discuss with them whether they should get an electrocardiogram,” he said.
The rates of death -- Adderall has been prescribed for 700,000 Americans according to Shire -- are too low for a randomized clinical trial to detect, but the FDA is considering conducting epidemiological studies to determine risk, Temple said.
In addition, the agency may compare results from its reporting system for patients on Adderall, Concerta and Ritalin to results for patients taking Strattera, the first non-stimulant approved to treat hyperactivity.
URL: http://www.msnbc.msn.com/id/6952353/
