Posted by Ron Hill on February 11, 2005, at 23:41:18
In reply to Adderall XR pulled in Canada, posted by Jen2 on February 10, 2005, at 20:29:41
Feb. 10, 2005 - Twelve sudden deaths in American kids taking Adderall have led Canada to suspend sales of the drug.
Adderall is an amphetamine drug used to treat children and adults with ADHD -- attention deficit hyperactivity disorder. It's sold in the U.S. in an immediate-release form and, as Adderall XR, in an extended-release form.
The FDA is not following the lead of Health Canada, the Canadian drug regulatory agency. After seeing the same reports in August 2004, the FDA at that time merely agreed to a label change for Adderall XR. That change made it clear that Adderall XR should not be given to patients with heart defects.
"FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada's analyses of adverse-event reports and FDA's own knowledge and assessment of the reports received by the agency," a Feb. 9 FDA statement says.
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 prescriptions for about 1 million patients worldwide. The reports of sudden death occurred in children taking Adderall or Adderall XR.
Shire strongly disagrees with Health Canada's interpretation of the deaths, says company spokesman Matthew Cabrey."Adderall and Adderall XR are safe, effective treatments for people diagnosed with ADHD," Cabrey tells WebMD. "There is no difference in the risk of sudden death in the population of people taking this drug compared to the population of people not taking this drug."
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."
What Parents Should Know
If your child is taking Adderall or Adderall XR, what should you do?
WebMD asked Leslie Rubin, MD, director of developmental pediatrics at Emory University School of Medicine.
"Everything we take has the potential for causing us grievous bodily harm, as innocuous as it may appear," Rubin tells WebMD. "We should really, whenever we take a medicine, be quite cognizant of its potential for causing harm."
But, Rubin says, there are excellent reasons to take these risks.
"When a medicine has been used widely and effectively and routinely, we should always be very cautious interpreting things like these Adderall reports," he says. "Taking a drug off the market for something like this is a mistake. Because a lot of people benefit from this drug. They depend on it for their day-to-day function."
If parents whose children are taking Adderall are worried, Rubin says, they have two basic options.
The first is to call their child's doctor and, with his or her approval, to stop giving them the drug until the doctor can give the child's heart a clean bill of health.
The other option is to continue giving the child Adderall, but to schedule an appointment with the child's doctor in order to discuss alternatives to Adderall treatment.
--------------------------------------------------------------------------------SOURCES: FDA, Statement on Adderall and Public Health Advisory for Adderall and Adderall XR, Feb. 9, 2005. Advisory, Health Canada, Feb. 9, 2005. News release, Shire Pharmaceuticals, Feb. 10, 2005. Russell Katz, MD, director, division of neuropharmacological drug products, office of drug evaluation, CDER, FDA. Matthew Cabrey, spokesman, Shire Pharmaceuticals. Leslie Rubin, MD, director of developmental pediatrics, Emory University School of Medicine; director, Marcus Center for Developmental Medicine, Marcus Institute, Atlanta; and co-director, southeast pediatric environmental health unit at the Rollins School of Public Health, Emory University, Atlanta.
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