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FDA Okays Use of Drug for Adults with ADHD 6-30-08
The FDA has expanded indications for methylphenidate (Concerta)
extended-release tablets to include adults with attention deficit hyperactivity
disorder, the drug's manufacturer announced.
Methylphenidate was already approved for treatment of ADHD in children ages six
to 18. The latest approval covers doses of 18 to 72 mg a day.
The FDA extension was based on clinical trial data in adults ages 18 to 65. In
those studies use of methylphenidate was shown to significantly improve ADHD
symptoms such as attention, impulsivity, and hyperactivity compared with
placebo.
The medication was generally well tolerated, with the most common adverse
reactions in adults being dry mouth, nausea, decreased appetite, headache, and
insomnia.
Methylphenidate is contraindicated in patients with significant anxiety,
tension, or agitation; glaucoma; tics; Tourette's syndrome or a family history
of Tourette's syndrome; current or past use of monoamine oxidase inhibitors (MAOIs);
or narrowing of the esophagus, stomach, or intestine.
The drug is not approved for treatment of children younger than six.
Comment:
Concerta is a terrible drug! Here is the laundry list for this drug and a link below for the full prescribing pdf.:
Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
Increase in Blood Pressure: Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.
Psychiatric Adverse Events: Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
Seizures: Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures
Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
Long-Term Suppression of Growth: monitor height and weight at appropriate intervals in pediatric patients
Gastrointestinal obstruction with pre-existing GI narrowing
Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy
Adverse Reactions--------------------------------------
The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was abdominal pain upper. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis. (6.1 and 6.2) The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased.
Do not use CONCERTA® in patients currently using or within 2 weeks of using an MAO inhibitor (7.1) • CONCERTA® may increase blood pressure; use cautiously with vasopressors (7.2) • Inhibition of metabolism of Coumarin anticoagulants, anticonvulsants, and some antidepressants (7.3) • Serious adverse events when using methylphenidate in combination with Clonidine (7.4)
CONCERTA® Prescribing Information
Most ADHD is a dietary problem and can be helped and often reversed with natural means.
First have extensive allergy testing done and stop eating those thing that are on the list. You also need to eat less or no grains and increase items high in omega 3! Visit Easy Substitutions for Healthier Living for more hints to get healthy and chemical free!
For memory loss: phosphatidyl serine 100 mg or more a day, Vinpocetine, DMAE, GABA, and Ginko Bilioba may be helpful.
Essential Oils for memory: Nightingale, Wisdom, Unity, Thyme, Ginger, coriander, Melissa, and Rosemary may be of help.
For Hyperactivity: Kava Kava, l-Acetylcarnitine, Passion Flower, California Poppy, OPC3's (Enhanced Life Preserver), Caffeine, SAMe, Magnesium
Essential Oils For Hyperactivity: Roman Chamomile, clary sage, linden blossom, Serenity, Lavender,
Things to avoid: Chemicals, Preservatives, Artificial Sweeteners (NutraSweet- Aspartame , Splenda -Sucralose, saccharin, neotame, acesulfame potassium), Caffeine if it makes you hyper, artificial colors, flavors, chlorine, fluoride, any food allergies or sensitivities. soy, wheat, cauliflower, Brussels sprouts, lima beans, cheese, sulfated alcoholic beverages,
Things to consume: Omega 3 rich foods : fish oil, coconut and oil, olive oil, flax seed, nuts, buffalo, ostrich, etc.. Nuts, seeds, fruits, berries, vegetables, beans, brown rice, caffeine if it helps etc.. organic sulfate free wine,