FDA (Government) Approved Dosing for Children
For a medication to be approved by the US Food and Drug Administration (FDA) for sale to the public, the pharmaceutical company producing it must submit the results of extensive research demonstrating the effectiveness and safety of the medication. Such studies can take years to complete and can be quite expensive (millions of dollars).
It is easier for a drug to pass the FDA testing requirement if it is tested at the lowest dose levels at which it may be effective. This way, side effects and other problems are less likely to occur, and the medication is more likely to be approved.
About forty years ago, drug manufacturers carried out tests on children of stimulants at doses up to 60 mg per day. At the time the tests were done, it was generally believed that ADD did not exist in adults, that children outgrew it. We now know that hyperactive symptoms often disappear in adulthood but that inattentive symptoms persist throughout the lifetime of well over half of all children with ADD.
The studies showed that the medications worked and were acceptably safe for children. They fairly consistently showed that the higher the dose, up to the highest level tested, the better the effect. After considering these studies, the FDA approved of the use of stimulants for children with ADD up to a dose of 60 mg per day. But since no studies had been done on adults, it made no approval statement about maximum doses for adults.
Many clinicians erroneously believe that the FDA’s maximum dose guideline apply to adults as well as children and will not prescribe higher doses to adults. In fact, the FDA guidelines are reflected in the information about stimulants appearing in the PDR which states…..
There are differences in how medications, including stimulants, are absorbed from the gut, how they are transported to the brain, how they act in the brain, and how they are distributed throughout the body. Effects of stimulants vary by gender, age, weight, genetic make-up, estrogen level, and other factors. For this reasons, the same dose of a medication might be much too low for one person and much too high for another. Setting the same maximum dosage for 50 pound chilren and 200 pound adults does not make sense scientifically.
Doctors who use higher doses have found that, as a general rule (but not always), the more a person weighs, the higher the dose of stimulants they will need to get a beneficial effect. Thirty milligrams twice a day might work for a 12 year old facing an eight hour school day, but two or three times that dose might be needed by a 250 pound adult who leaves his job at 5 PM and then has to do work at home and/or interact calmly and productively with family members in the evening. This has even become clear with the treatment of children, most of whom benefit from drug dosing after the school day in order to their homework, interact with family members, and in the case of older teen-agers, work after school. In one of the largest studies of the effects of treatment for ADD ever carried out, the Multimodal Treatment Study, one of the most common causes of poor outcome was found to be under-dosing.
There is little published research articles on the benefits or risks of supervised treatment of adults using daily doses higher than 60 mg per day (for Vyvanse 70 mg per day) despite the fact that most patients takig higher doses have benefited from them with no ill effects. It is noteworthy that virtually all studies of adults using dosing limited by the FDA guidelines have found that the highest doses allowed are more effective than lower doses without causing significantly more side effects.
It has been found that adults taking higher doses are slightly more likely to experience paranoia, fast heart beat, loss of appetite, and weight loss. However, the frequency of depression, drug-seeking behavior, suicide-related behaviors, and hypertension does not appear to differ significantly from those taking standard doses.
The abusive use of higher dose stimulants or the use of stimulants for recreational purposes has cast a shadow on the therapeutic use of off-label doses by responsible clinicians. However, the irresponsible use of stimulants by some people and/or the unsupervised use of excessively high doses by a small percentage of patients or the lethal effect of amphetamines mixed with street drugs does not justify withholding higher than 60 mg per day doses from responsible patients who have no medical contraindications to such treatment.
A note of caution: After reading this page, you may think that you should try a higher dose of your medication. Do not increase your dose of stimulants without the approval of your doctor as there may be medical or other reasons that a higher dose may not be healthy, or might be dangerous, for you.
