ADD and ADHD Medications
Recent studies have shown that the reliability of certain medications given to individuals to treat attention deficit disorder (ADD) may be affected by what they eat for breakfast. As a parent, you need to be sure that the medication your child is taking to alleviate the symptoms of ADD is working at the optimal therapeutic level.
Information gathered from the CAFÉ (Concerta, Adderall XR, Food Evaluation) study indicates that blood levels of people taking a single dose of Concerta are not affected by what they consume for breakfast. This gives the individual a consistent therapeutic effect throughout the day. In contrast, the medication Adderall XRTM (extended release) that has been widely used in treating the symptoms of ADD was shown to decrease by 55 percent in the bloodstream during the first four hours after the initial dose.
The study suggests that the effect of certain kinds of food may be directly related to the effectiveness and consistency of the therapeutic benefits of the medication.
In the CAFÉ study, conducted by the McNeil Consumer and Specialty Pharmaceuticals in Fort Washington, Pa., a high-fat breakfast was given to participants following a morning dose of two extended-release attention deficit hyperactivity disorder (ADHD) stimulant medications. The patients had undergone an overnight fast prior to the breakfast. Blood samples were then collected at consistent intervals throughout the day up to 28 hours after the dose. Subjects were also monitored throughout the day for adverse reactions and side effects.
The extended release medications that were used – Concerta and Adderall – are taken once a day and provide the initial dose of medication right after the dose is taken. Throughout the day, the medication releases gradually. For patients to receive the full benefits of the extended-release medication, it is vital for there to be consistency in delivery and absorption in the first four to eight hours.
"Because breakfast diets may change every day, an extended-release stimulant medication with a delivery system susceptible to alteration by food may result in clinically-relevant, day-to-day fluctuations in blood levels, which may affect the medication's desired improvement in symptoms of ADHD," says Cathy Gelotte, Ph.D., executive director of medical and regulatory product development at McNeil Consumer and Specialty Pharmaceuticals. "This study demonstrates the unique OROS delivery system of Concerta is largely unaffected by food and thereby provides a reliable and consistent daily therapeutic effect."
Essentially, for a parent, this means that you could be sending your child to school with the assumption that they are receiving the full benefits of the stimulant medication, when in fact what they eat in the morning may hinder the therapeutic effectiveness.
Parents should talk with their physicians about any concerns they may have about the medications they are giving their child and whether or not there are implications regarding diet and effectiveness of the drug.
A Parent's Story of Struggle
"My son has ADHD and was diagnosed in the third grade," says Jeanua Gilson of Gilbert, Ariz. "Merry-go-round is the best description of this early diagnosis. My son has been on every medication imaginable." Gilson's son had a lot of adverse side effects on his medications, including serious weight loss. "We tried Dexedrine, Adderall, Ritalin – you name it," she says. "The stomachaches, heart palpitations were just not worth it. And then when the medication wore off, he got the 'afternoon nasties.' There was nothing you could do."
Gilson heard that Dr. Kohout was participating in the Concerta study and was shocked by the results. "Children were gaining weight, focusing, eating, growing and developing with absolutely no side effects," says Gilson. "My son started on Concerta the summer before he was a freshman in high school. He is now going to be a sophomore. His weight went from 68 pounds to 105 pounds. He suddenly started developing and growing. He is a different child. He eats and eats. There are no more afternoon nasties. This medication titrates down so slowly that there is not a big drop. Simply stated, they just glide off of it."
Gilson has been delighted with the performance of Concerta and says that the lack of side effects for her son has been a blessing for her family. Gilson also started taking Concerta after trying other medications for her own diagnosis of ADHD.
She has noticed a drastic improvement in her own life with her focusing skills, concentration and also her social skills. "My social skills are beyond anything I could have ever dreamed," says Gilson. "My husband was so used to jumping around trying to figure out what topic I was on – poor man! Now we can actually carry on conversations. My son and I are no longer flying at Mach II with our hair on fire."
As with any other medication, there is the possibility of side effects in some individuals. Parents should always consult their physician with any questions or concerns about medications. For more information on Concerta, you can visit their Web site at www.concerta.net.
"Concerta is the only stimulant preparation that is recognized by the FDA as having a 12-hour duration of action. Although other methylphenidate preparations are likewise described by their manufacturer as being 'extended-release,' these other products generally last eight to nine hours, not 12," says Dr. Andrew Adesman, director of development and behavioral pediatrics at Schneider Children's Hospital in New Hyde Park, N.Y. "Concerta is distinct from other medications in that it has a unique drug delivery system (the OROS system), which leads to continued release of medication for hours after the tablet has left the stomach. All other long-acting MPH preparations either use a wax-matrix tablet or time-release beads in a capsule."
Dr. Adesman points out that as children generally take their ADHD medication first thing in the morning, around the time they are having their breakfast, it is crucial not to ignore the possible effects of food on the absorption of the drug they are taking. "Celltech, the manufacturer of Metadate CD (an eight- to nine-hour extended-release MPH preparation) acknowledges that a high-fat food delays the peak MPH level by at least an hour," says Dr. Adesman. "The recent CAFÉ study comparing Adderall XR and Concerta demonstrated that a high-fat diet likewise significantly affected the absorption of the amphetamine salts in Adderall XR whereas MPH absorption was not affected by the presence of food in this study."
These recent studies show strong evidence that food can significantly compromise the intended time course of the effects of certain medications. It must be noted that the absorption of MPH released by Concerta was not affected by food in the CAFÉ study.
"Moreover, day-to-day changes in breakfast foods may lead to daily variability in the time course of the clinical response to a constant dose of Adderall XR," says Dr. Adesman. "These food effects, although not studied from a clinical standpoint, may explain why medications are more effective some days than others."
With the recent advances in medications for children diagnosed with ADD/ADHD, parents should be aware of their choices, kept up to date on new studies and advances that would alleviate side effects and be educated on how to administer it correctly to allow for the optimal results.