Excerpted from an article in www.WebMD.com titled, "Sudden Death in 12 Kids on ADHD Drug Adderall"
Shire Pharmaceuticals - the manufacturer of Adderall -- reported the 12 child deaths to U.S. and Canadian regulatory agencies. They occurred in the U.S. between 1999 and 2003 - a time when doctors wrote more than 37 million Adderall prescriptionsfor about 1 million patients worldwide. The reports of sudden death occurred in children taking Adderall or Adderall XR.
The 12 deaths were in 7- to 16-year-old U.S. boys. They'd been taking Adderall products for as little as one day or as long as eight years. Five of the deaths were in kids with known heart defects. Many of the other seven children had unusual circumstances that make the link to Adderall hard to interpret, says Russell Katz, MD, director of the FDA's neurological drugs office.
"One child was in a boot camp and exercising in 110 degrees," Katz says. "Two others had high blood levels of the drug, possibly reflecting an overdose.
From www.LawyersandSettlements.com :
In 2004, Shire Pharmaceuticals, the Adderall distributor, voluntarily reported to the FDA 20 deaths by heart attack and 12 strokes: Fourteen of those deaths and two of those 12 strokes were in children. Most of those deaths occurred in individuals who were taking Adderall in a prescribed manner. Adderall is manufactured by Catalytica Pharmaceuticals Inc. of Greenville, North Carolina and is distributed by Shire. Generic equivalents (known as "amphetamine salts," "mixed amphetamines," or simply "amphetamines," to pharmacists) are also distributed in the US by Mallinckrodt Pharmaceuticals and Ranbaxy Laboratories.
In 2005, Health Canada suspended sales of Adderall following reports of possibly 20 sudden deaths and 12 strokes. However, the stimulant was put back on the Canadian market six months later because an independent panel couldn't "accurately ascertain whether the drug increases risk of cardiac death." Health Canada is closely monitoring the Adderall risks and Adderall side effects.
In early 2006, the FDA's advisory panel learned that during the time period 1999 to 2003 there were 81 deaths and 54 non-fatal cardiovascular events possibly linked to the ADHD/ADD drugs. Adderall was involved in more fatal case reports than any other ADHD/ADD drug, with 24 deaths reported during 1999 to 2003. The chairman of the panel, Dr. Peter Gross, likened Adderall to Vioxx (Vioxx was recalled after a long delayed discovery that it substantially increases risk of heart attack or stroke). The panel concluded a black box warning was needed on Adderall and the other ADHD/ADD drugs.
However, Shire Pharmaceuticals, the manufacturer, stated that it agreed with the FDA's desire for more safety studies concerning its drug, but disagreed with the FDA advisory panel's recommendation that a black-box warning be put on Adderall. Sales of Adderall XR, distributed by Shire Pharmaceuticals, were $759 million in the US in 2004 and $10 million in Canada.