Adderall (
Dextroamphetamine)

Generic name: Dextroamphetamine

FDA Issues Adderall Advisory

February 9, 2005: After the sudden deaths of 12 American children on Adderall for attention deficit hyperactivity disorder (ADHD) treatment, Canada has suspended sales of the drug within its borders. The U.S. Food and Drug Administration does not feel a full recall is necessary, but has released an advisory statement.

"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 statement says.

The statement also urges parents of children on Adderall to consult with the child's physician before making any changes to the treatment.

ADHD drug Adderral pulled in Canada -
The popular drug, which has been linked to 20 sudden deaths worldwide, mostly in children, was taken off the Canadian market Wednesday, sparking questions about whether kids in the USA should be using it.

The Food and Drug Administration issued a public health advisory on its Web site saying that the rate of sudden death for children on Adderall XR is no higher than for those not on the drug. But children with heart defects could be at higher risk.

Parents are making decisions about stimulants such as Adderall XR with few facts, says Julie Magno Zito, an epidemiologist at the University of Maryland. There are no good long-term studies of such medicines, she says. Rare side effects of a drug won't surface in short studies unless they include a huge number of kids, such as in a national HMO, and that kind of study hasn't been done on Adderall XR, Zito says.

About 700,000 children in the USA take Adderall XR, a timed-release stimulant, and 300,000 use Adderall, a version that often needs to be taken more than once a day, according to Shire Pharmaceuticals Group PLC, maker of the drug.

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Adderall Side Effects
as reported by "The PDR® Family Guide To Prescription Drugs®"

Most important fact about adderall:
Adderall, like all amphetamines, has a high potential for abuse.  If used in large doses over long periods of time, it can cause dependence and addiction.  Be careful to take Adderall only as prescribed.

Adderall Side effects may include:
Changes in sex drive, constipation, depression, diarrhea, dizziness, dry mouth, exaggerated feelings of well-being, headache, high blood pressure, hives, impotence, insomnia, loss of appetite, mental disturbances, overstimulation, rapid or pounding heartbeat, restlessness, stomach and intestinal disturbances, tremor, twitches, unpleasant taste, weakened heart, weight loss, worsening of tics (including Tourette's syndrome)

Why should adderall not be prescribed:
Do not use Adderall if you have any of the following conditions:

Heart disease
Hardening of the arteries
High blood pressure
High pressure in the eye (glaucoma)
Overactive thyroid gland

Never take Adderall within 14 days of taking an antidepressant classified as an MAO inhibitor, including Nardil and Parnate.  A potentially life-threatening spike in blood pressure could result.

Your doctor will not prescribe Adderall if you have ever had a reaction to similar stimulant drugs.  The doctor will also avoid prescribing Adderall if you appear agitated or are prone to substance abuse.

Special warnings about adderall:
If you have even a mild case of high blood pressure, take Adderall with caution.  Be careful, too, about driving or operating machinery until you know how this drug affects you.  It may impair judgment and coordination.

Adderall can make tics and twitches worse.  If you or a family member has this problem (or the condition called Tourette's syndrome), make sure the doctor is aware of it. 

If the problem is attention-deficit disorder, the doctor will do a complete history and evaluation before prescribing Adderall, taking particular account of the severity of the symptoms and the age of your child.  If the problem is a temporary reaction to a stressful situation, Adderall is probably not called for.

At present, there has been no experience with long-term Adderall therapy in children.  However, other amphetamine-based medications have been known to stunt growth, so your doctor will need to watch the child carefully.

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