Adderall, a prescription medication used for treating Attention Deficit Hyperactivity Disorder was approved by the FDA in 2002. Shire pharmaceuticals created the ADHD drug which contains four amphetamine salts including dextroamphetamine and is used by at least 800,000 Americans today. Adderall brought in at least $760 million dollars from US consumers and over $10 million from Canada in 2004 alone.
ADHD, or Attention Deficit Hyperactivity Disorder is found among children and adults and is manifested in various symptoms including hyperactivity, forgetfulness, somewhat manic mood shifts, poor impulse control, and distractibility in all manner of tasks. Doctors who seek to treat children and adults with ADHD will typically prescribe a combination of medication and behavioral therapies. The medications typically used to treat ADHD are stimulants, which work by stimulating parts of the brain that are responsible for focus, attention, and impulse control. By stimulating the correct parts of the brain, many of the behaviors characterized by ADHD sufferers are effectively controlled.
Although Adderall is a very popular medication and has worked effectively with some patients, there have been some instances of serious Adderall side effects. Shire Pharmaceuticals has stated that there have been 20 reports of sudden deaths during use of Adderall since 1994. Of the 20 deaths, 12 were a direct result of stroke, and 2 were in children. Although the FDA was aware of these deaths, they still gave approval for the drug to be sold.
Health Canada suspended the distribution of Adderall in early 2005 because they felt that the deaths caused by the drug could not be handled with a label warning, saying "identified risk of sudden death following the recommended doses cannot be managed by label changes." On January 3, 2006, the FDA asked its risk management committee to review several reports of heart-related complications in children and adults using ADD drugs. Regulators in the U.S. and Canada have concerns about the number of patients with complications stemming from these drugs which use stimulants like amphetamine to improve concentration.
The FDA, in 2006, reviewed Adderall, Concerta, and Strattera, the three main drugs prescribed for adults and children who suffer from Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. They then narrowly voted on proposing the most serious type of warning labels for Adderall, Concerta, Ritalin as well as other ADHD drugs. The addition of the “black box” safety warnings to ADHD drugs was recommended and this is significant because of their widespread use. Doctors prescribe these and other ADHD drugs to almost 2 million children and 1 million adults a month.
The FDA's data did suggest a link between ADHD drugs and an increased heart problems and risk of sudden death. A federal health official confirmed that there was a strong possibility the drugs were linked to the deaths of 25 people between 1999 and 2003. Out of those 25 deaths, 19 were children. The report also cited approximately 50 cases of heart problems in both adults and children who took ADHD drugs like Adderall.
If you are your child are a victim of bad side effects from Adderall or another ADHD medication, you should contact a product liability attorney immediately to research your claim.