ADDERALL® is a Central Nervous System (CNS) stimulant or amphetamine, approved in the U.S. for the management of Attention Deficit Hyperactivity Disorder (ADHD). Adderall XR is currently prescribed to thousands of adults, children, and adolescents diagnosed with ADHD and generates over $600 million in annual revenues.
Due to reports of heart attacks and sudden death in patients taking Adderall and similar ADHD drugs, the FDA is urging the makers of these drugs to include a Black-box warning on the drug's label to warn about the risk of cardiovascular events such as stroke, heart attack or sudden death.
According to the American Psychiatric Association, ADHD is the most commonly diagnosed mental health disorder in children. Adderall XR is approved for children 6 years of age and older but may be prescribed to children younger than 6 years of age. Symptoms of ADHD include hyperactivity, impulsivity and inability to concentrate.
Adderall and Death
On February 9, 2005 Health Canada instructed Shire BioChem Inc., to withdraw Adderall from the Canadian market due to information allegedly linking the drug with sudden deaths, heart-related deaths, and strokes in children and adults.
There have been at least 20 international reports of sudden death in patients taking either ADDERALL® or ADDERALL XR®. Fourteen deaths occurred in children, and six deaths in adults. There were 12 reports of stroke, two of which occurred in children. These deaths were not associated with overdose, misuse or abuse.
Adderall's label currently warns, "Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events." Normal side effects of the drug include loss of appetite, difficulty falling asleep, stomachache, headache, weight loss, and dry mouth. Adderall contains amphetamine which is a strong stimulant found in some weight loss medications.
Adderall in the News
US regulators have slapped another warning on drugs for attention deficit hyperactivity disorder, including Shire Pharmaceuticals' top-selling Adderall XR drug. (Mar-17-06) [
INDEPENDENT]
Upon FDA's ruling, Adderall manufacturer, Shire wants more studies before changing the label on their popular drug. (Feb-10-06) [
FORBES]
The FDA's Drug Safety & Risk Management Advisory Committee rules that ADHD drugs should have a warning label which explains the risk of heart attack and sudden death. (Feb-10-06)
[ FDA ]
Register your Adderall Case
If you or a family member has been affected by Adderall, you may qualify for damages or remedies that might be awarded in a possible class action or lawsuit. Please fill out the Adderall Complaint form below.
