ADDERALL
A review of the data from the FDA's Adverse Event Reporting System database for the years 1999 through 2003 identified 12 cases of sudden death in pediatric patients (1 to 18 years of age) who were being treated for ADHD with Adderall or Adderall XR
What Is Adderall?
Generic Name: Amphetamine-Dextroamphetamine
Brand Names: Adderall, Adderall XR
Adderall is a central nervous system stimulant (amphetamine). Adderall is used to treat attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older and in adults.
What should you know about amphetamine-dextroamphetamine?
Use caution when driving, operating machinery, or performing other hazardous activities. Amphetamine-dextroamphetamine may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities.
Amphetamine-dextroamphetamine is habit forming. Physical and psychological dependence may occur with the use of this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually.
Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Amphetamine-dextroamphetamine generally should not be used in children or adults with structural cardiac abnormalities.
Do not crush or chew the extended-release form of amphetamine-dextroamphetamine (Adderall XR). If swallowing the capsules is difficult, a capsule can be opened and the entire contents sprinkled on a small amount of applesauce. The mixture should be consumed immediately, and not saved for later use. The mixture should be swallowed whole, without chewing the sprinkled beads. The dose of a single capsule should not be divided.
Who Should Not Take Adderall?
You should not take Adderall if you have:
- A heart defect
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Other heart problems, including high blood pressure, and heart or blood vessel disease
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Overactive thyroid
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Glaucoma
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A history of drug abuse
Never take Adderall if you are taking a drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Adderall close in time to an MAOI can result in serious, sometimes fatal, reactions, including:
- High body temperature
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Coma
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Seizures (convulsions)
MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxid), and other brands.
What Are The Risks and Possible Side Effects?
Sudden deaths: See FDA Alert.
Abuse potential: See Warning.
Worsening mental illness (psychosis): Adderall may make symptoms of existing mental illness worse.
Possible decreased growth and weight loss: Adderall may decrease growth and cause weight loss. Children who take it for a long time should have their growth and body weight measured regularly.
If you experience any of the following serious side effects, stop taking amphetamine-dextroamphetamine and seek emergency medical attention:
· an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
· an irregular heartbeat or very high blood pressure (severe headache, blurred vision); or
· hallucinations, abnormal behavior, or confusion.
Other, less serious side effects may be more likely to occur. Continue to take amphetamine-dextroamphetamine and talk to your doctor if you experience
· restlessness or tremor;
· anxiety or nervousness;
· headache or dizziness;
· insomnia;
· dryness of the mouth or an unpleasant taste in the mouth;
· diarrhea or constipation; or
· impotence or changes in sex drive.
Amphetamine-dextroamphetamine is habit forming. Physical and psychological dependence may occur with the use of this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually.
Increased tics: Adderall may worsen tics and Tourette's disorder.
Pregnancy: Tell your healthcare professional if you are or may be pregnant because your baby may be premature or have a low birth weight. Also, your baby may show withdrawal symptoms, such as agitation and drowsiness
Breast feeding: Do not breast feed while taking Adderall because it can pass into your breast milk.
Other side effects include loss of appetite, difficulty sleeping, dry mouth, headaches, and mood changes.
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially
bothersome.
Tell your healthcare professional about any medical conditions you have in addition to those already mentioned in this information sheet.
Are There Any Interactions With Drugs or Foods?
Adderall may interact with other medicines. These interactions can cause serious side effects. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take, especially:
- Those used to treat depression, known as tricyclic antidepressants and monoamine oxidase inhibitors (MAOI)
- Antacids
- Those used to treat urinary problems
- Diuretics
- Propoxyphene (Darvon, Darvocet), a pain medicine
How Do I Take Adderall ?
Adderall is taken by mouth, in the morning, with or without food, exactly as prescribed by your healthcare professional.
Swallow Adderall capsules whole or open the capsule and sprinkle the contents on a spoonful of applesauce. Take right away without chewing.
IMPORTANT WARNING
The combination of dextroamphetamine and amphetamine can be habit forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor. If you take too much dextroamphetamine and amphetamine you may find that the medication no longer controls your symptoms, you may feel a need to take large amounts of the medication, and you may experience symptoms such as rash, difficulty falling asleep or staying asleep, irritability, hyperactivity, and unusual changes in your personality or behavior. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
Do not stop taking dextroamphetamine and amphetamine without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression and extreme tiredness if you suddenly stop taking dextroamphetamine and amphetamine after overusing it.
Do not let anyone else take your medication. Store dextroamphetamine and amphetamine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules are left so you will know if any are missing.
The combination of dextroamphetamine and amphetamine may cause sudden death or serious heart problems especially if the medication is misused. Be sure to tell your doctor if you have or ever had a heart defect or other heart problems such as high blood pressure and heart or blood vessel disease.
