Adderall XR Drug Warning
Thursday February 10, 2005
Many parents and Pediatricians were surprised by the report that Health Canada suspended sales of the ADHD drug Adderall XR because of health concerns, including a possible association of sudden deaths, heart related deaths, strokes.
Health Canada's decision came after a review of postmarketing safety data, which revealed that there have been 20 deaths among children and adults taking Adderall and Adderall XR since 1999. It should be noted that many of these deaths occured in patients who had underlying heart disease.
It should also be noted that the '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.'
The FDA has also stated that '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.'
So basically the FDA has stated that they do not feel that Adderall and Adderall XR should stop being taken by the almost 1 million children and adults who have currently been prescribed these drugs in the United States.
The FDA has also reported that they 'cannot conclude that recommended doses of Adderall can cause SUD' or sudden unexplained death. And that is good news for parents of children who have ADHD and are being helped by taking Adderall XR.
If you are still concerned, be sure to talk to your Pediatrician.
Parents can also be reassured that 'an update and further analyses of the data are currently in progress. '
Health Canada's decision came after a review of postmarketing safety data, which revealed that there have been 20 deaths among children and adults taking Adderall and Adderall XR since 1999. It should be noted that many of these deaths occured in patients who had underlying heart disease.
It should also be noted that the '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.'
The FDA has also stated that '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.'
So basically the FDA has stated that they do not feel that Adderall and Adderall XR should stop being taken by the almost 1 million children and adults who have currently been prescribed these drugs in the United States.
The FDA has also reported that they 'cannot conclude that recommended doses of Adderall can cause SUD' or sudden unexplained death. And that is good news for parents of children who have ADHD and are being helped by taking Adderall XR.
If you are still concerned, be sure to talk to your Pediatrician.
Parents can also be reassured that 'an update and further analyses of the data are currently in progress. '
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