FDA Recommends Strong Warning Labels On the ADHD Drugs
by Medindia Content Team on March 18, 2006 at 2:14 PM Corporate News
Shire Pharmaceuticals' top-selling Adderall XR drug for attention deficit hyperactivity disorder (ADHD) needs to carry stronger warnings about the risk of side effects says the US FDA regulators.
It has asked the drug company to make clear to the public about the side effects of the drug such as hallucinations and paranoia.
This can occur in some patients with no identifiable risk factors. The FDA had prepared a report about a seven-year-old boy who, after taking ADHD drugs imagined seeing people sitting in a rocking chair and people coming into the house and stealing Christmas presents. Another such incident is that of a five-year-old boy who said he saw snakes and polka-dot alligators.
The spokesman for Shire said that it was too early to speculate on the outcome of next week's meeting. He said that any type of enhanced warning should be based on scientific data. But there is not enough data at the moment to warrant enhanced warnings.
The FDA's Drug Safety and Risk Management Advisory Committee talked about the heart risks due to the usage of ADHD drugs. The FDA advisory panel said that the ADHD drugs namely the Shire's Adderall and Novartis's Ritalin, should carry black box warnings highlighting the risk of heart attacks.
Thomas Laughren, director of the Division of Pyschiatry Products at the FDA, said that as of now nothing has to be changed and the labeling right now is adequate.
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Adult Attention-Deficit Hyperactivity Disorder (ADHD)
Adult attention-deficit hyperactive disorder (ADHD) is a mental health condition in adults seen as hyperactivity, impulsiveness and reduced attention. ADHD impairs social, academic, neuropsychological and occupational behavior.
Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder that affects normal behavior and impairs the ability to concentrate.
Diet to control Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder (ADHD) is a neurological disorder that affects children of school going age and often subsides as the child matures.
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a drug, reaction to a drug or drug abuse.
Dyscalculia / Learning Disabilities
Dyscalculia is a learning disability involving mathematics. Recognized by The WHO, it affects nearly 4 – 7% of the world population. If you have dyscalculia it tends to affect every aspect of your life.
Dyslexia is a reading disability that occurs when the brain does not properly recognize and process certain symbols.
Mind-wandering
Mind wandering is a spontaneous and unintentional shifting of attention of thoughts from a primary task that can happen in varying degrees.
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