Adderall Advisory by FDA

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" colspan=2 height=90 BGCOLOR="#FFFFFF" TEXT="#080000" background="127015b3.jpg"> <div> <B>Adderall Advisory by FDA</B><B>  |  </B><FONT SIZE="5" COLOR="#000000" FACE="Arial" ><A HREF="http://help4self.net" TARGET="_top" TITLE="http://help4self.net"><B>Home</B></A></FONT></div> <div> </div> </td> </tr><tr> <td valign="top" width=180 BGCOLOR="#FFFFFF" TEXT="#080000"> <div> <A HREF="id39.htm" TARGET="_top" TITLE="ADHD Has Its Good Points">ADHD Has Its Good Points</A></div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700c800000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Adderall Advisory by FDA</B></div> <div> <A HREF="id103.htm" TARGET="_top" TITLE="Adolescent Depression FDA Warning">Adolescent Depression & FDA Warning</A></div> <div> <A HREF="id44.htm" TARGET="_top" TITLE="Anxious Children">Anxious Children</A></div> <div> <A HREF="id45.htm" TARGET="_top" TITLE="Depression in Children">Depression in Children</A></div> <div> <A HREF="id46.htm" TARGET="_top" TITLE="Fearful Child">Fearful Child</A></div> <div> <A HREF="id47.htm" TARGET="_top" TITLE="Good Behavior is Catching">Good Behavior is Catching</A></div> <div> <A HREF="id48.htm" TARGET="_top" TITLE="Learning from Mistakes">Learning from Mistakes</A></div> <div> <A HREF="id50.htm" TARGET="_top" TITLE="Rewards Can Backfire">Rewards Can Backfire</A></div> <div> <A HREF="id51.htm" TARGET="_top" TITLE="SelfEsteem that Counts">Self-Esteem that Counts</A></div> <div> <A HREF="id52.htm" TARGET="_top" TITLE="Children Need Sleep">Children Need Sleep</A></div> <div> <A HREF="id53.htm" TARGET="_top" TITLE="Unpleasant Tasks">Unpleasant Tasks</A></div> <bR> </td> <td valign="top" height=390 width="100%" BGCOLOR="#FFFFFF" TEXT="#080000"> <div> Public Health Advisory for Adderall and Adderall XR</div> <bR> <div> Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR</div> <div> in the Canadian market. Adderall XR is a controlled release amphetamine used to treat</div> <div> patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was</div> <div> based on U.S. post-marketing reports of sudden deaths in pediatric patients.</div> <div> Adderall XR is approved in the United States for the treatment of adults and pediatric</div> <div> patients 6 years of age and older with ADHD, and Adderall, the immediate-release</div> <div> formulation of the drug, is approved for pediatric patients with ADHD. The Food and Drug</div> <div> Administration (FDA) has been aware of these post-marketing cases, and evaluated the risk</div> <div> of sudden death with Adderall prior to approving the drug for treatment of ADHD in adults</div> <div> last year.</div> <bR> <div> Of 12 total cases, five occurred in patients with underlying structural heart defects (abnormal</div> <div> arteries or valves, abnormally thickened walls, etc.), all conditions that increase the risk for</div> <div> sudden death. Several of the remaining cases presented problems of interpretation, including</div> <div> a family history of ventricular tachycardia, association of death with heat exhaustion,</div> <div> dehydration and near-drowning, very rigorous exercise, fatty liver, heart attack, and type 1</div> <div> diabetes mellitus. One case was reported three to four years after the event and another had</div> <div> above-toxic blood levels of amphetamine. The duration of treatment varied from one day to 8</div> <div> years. The number of cases of sudden deaths reported for Adderall is only slightly greater,</div> <div> per million prescriptions, than the number reported for methylphenidate products, which are</div> <div> also commonly used to treat pediatric patients with ADHD.</div> <bR> <div> The FDA is continuing to evaluate these and other post-marketing reports of serious adverse</div> <div> events in children, adolescents, and adults being treated with Adderall and related products.</div> <div> When one considers the rate of sudden death in pediatric patients treated with Adderall</div> <div> products based on the approximately 30 million prescriptions written between 1999 and 2003</div> <div> (the period of time in which these deaths occurred), it does not appear that the number of</div> <div> deaths reported is greater than the number of sudden deaths that would be expected to occur</div> <div> in this population without treatment. For this reason, the FDA has not decided to take any</div> <div> further regulatory action at this time. However, because it appeared that patients with</div> <div> underlying heart defects might be at increased risk for sudden death, the labeling for Adderall</div> <div> XR was changed in August 2004 to include a warning that these patients might be at</div> <div> particular risk, and that these patients should ordinarily not be treated with Adderall</div> <div> products.</div> <bR> <div> Date created: February 9, 2005</div> <bR> </td> </tr></table></body>