14 deaths force halt to drug in Canada – Hyperactivity remedy called threat to kids

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Star-Ledger
14 deaths force halt to drug in Canada
Hyperactivity remedy called threat to kids
Friday, February 11, 2005
BY CAROL ANN CAMPBELL

Safety concerns have clouded the future of another blockbuster medication, this one a hyperactivity drug prescribed to 700,000 Americans, most of them children.

Health officials in Canada have suspended sales of Adderall XR, citing international reports of sudden deaths and strokes in children and adults.

Health Canada, the country’s counterpart to the U.S. Food and Drug Administration, cited reports of 14 deaths in children and six in adults. The deaths were not associated with misuse of the drug. There also were 12 reports of stroke, two in children, according to Health Canada. It is unclear whether any of the deaths occurred in the U.S.

The FDA has access to the same international reports, but has declined to suspend sales or add warnings about the drug, which is used to treat Attention Deficit Hyperactivity Disorder. The FDA has consulted with Canadian authorities, but “does not feel any immediate changes are warranted,” an FDA statement released yesterday said.

News about the drug has raised concerns among doctors who treat children with ADHD, a disorder that affects 3 percent to 5 percent of school-age children. Children with the ADHD can have short attention spans and difficulty concentrating. Many have learning disabilities.

“We’ve become reliant on these drugs,” said Larry Diller, the author of two books on ADHD. “If used appropriately, these drugs can make a huge difference.”

Critics of the FDA are criticizing the agency for not moving to suspend sales of Adderall. The agency is already under fire for not moving more quickly to take Vioxx, a best-selling painkiller, off the market. In October, Merck of Whitehouse Station pulled Vioxx off the market after a study found the drug doubled the risk of heart attack and stroke.

Critics are again pointing fingers at the FDA.

“Why is the American public entitled to less safety than Canadians?” asked Vera Hassner Sharav, president of the Alliance for Human Research Protection, a non-profit group based in New York. “If you’ve got these deaths and strokes, even in children, who generally don’t get heart attacks and strokes, you should pull the drug off the market until the manufacturer can prove it’s safe.”

The watchdog group Public Citizen, another frequent critic of the FDA, said it will begin an immediate analysis of the international database of adverse events related not just to Adderall, but to similar drugs, such as Ritalin. Adderall is not on Public Citizen’s list of dangerous drugs.

Larry Sasich, a pharmacist and research analyst at Public Citizen, said Adderall is an amphetamine that raises blood pressure and heart rate. “It is a plausible way in which this drug could harm people,” Sasich said.

The maker of the drug, Shire Pharmaceuticals Group PLC, based in Basingstoke, England, said it strongly disagrees with conclusions drawn by Health Canada and is considering “responsive action.”

It called the drug safe, and a statement released yesterday said it put a warning on the drug saying it should “generally not be used in children or adults with structural heart problems.”

Staff writers Peggy O’Crowley and Ed Silverman contributed to this report.

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