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Deaths link to Adderall Cannot be Proven
http://www.webmd.com/content/article/100/105792.htm
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. They way we try to assess causality -- to ask, 'Did the drug do this?' -- it is hard to answer that by looking at an individual case. Just because a child died while on Adderall doesn't mean the drug was the cause. It could have been 50 different causes. So we look at how many deaths there were in kids exposed to Adderall, and compare that to the background rate in the population. We don't really believe this is different than background rate, although we have no good data on the actual background rate of sudden death in all kids -- or in kids with ADHD, who may have a higher background rate." http://www.fda.gov/cder/drug/advisory/adderall.htm When one considers the rate of sudden death in pediatric patients treated with Adderall products based on the approximately 30 million prescriptions written between 1999 and 2003 (the period of time in which these deaths occurred), it does not appear that the number of deaths reported is greater than the number of sudden deaths that would be expected to occur in this population without treatment. For this reason, the FDA has not decided to take any further regulatory action at this time. If you disagree, provide scientific proof that this is wrong. |
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