The article appeared in the February 10th edition of The Wall Street Journal; “Canada Halts Adderall Sales, Citing Deaths.” The distraught phone calls came to our office in the ensuing days.
“My son’s been on Adderall for three years and he has done great in school. What are we gonna do? There is no way he can function in school without Adderall...it would be a nightmare all over again,” lamented one mother. Another parent called and said, “Billy just got his report card, and for the first time in his life he has made the honor roll. We started him on Adderall at the beginning of this semester. Last year it was D’s and F’s. After reading the article in The Wall Street Journal I am really afraid. What should I do?”
Clearly this article blindsided health care professionals who deal with ADD in the United States. Before one can make a logical decision about the use of Adderall, one must look at all of the facts.
Attention Deficit Disorder, ADD, is a disorder that affects anywhere from one-to-three percent of all school-age children. The symptoms include inattention, impulsivity and hyperactivity. It is more common in males than in females. The symptoms become evident by first grade in patients with hyperactivity and as late as fourth grade in patients without hyperactivity. A person with ADD does not have to have all three symptoms to carry the diagnosis. They may simply be inattentive, or lack impulse control. Not all patients who have ADD are hyperactive.
Physicians have been successfully treating ADD with stimulant medications since the 1960’s. The standard medications have been Ritalin and Dexedrine. One drawback with these has been their short half-life. In other words the body metabolizes these medications most rapidly. Therefore, a single dose taken in the morning would last for three-to-four hours. This would necessitate the student taking another dose at lunchtime, and possibly taking another dose in the afternoon to allow him to complete his homework. While this was successful in many cases, some students balked at having to go to the school nurse during lunch to “take my medicine.” In other cases, the early dose would wear off mid-morning, which would cause problems in school performance until they took their lunchtime dose. What was needed was a long-acting preparation that would cover the student throughout the school day and into homework time.
This was successfully achieved with the licensing of Concerta, a long-acting form of Ritalin and, in 1994, Adderall, a long-acting form of Dexedrine. These medications were a tremendous improvement in the treatment of ADD, allowing the student to take one dose in the morning and having it control their ADD throughout the school days.
Adderall was subsequently found not to have the long-lasting effects that were initially hoped for. It would last longer than Dexedrine, but in some cases the benefit would wear off shortly after lunchtime. In 2001, the company that manufactures Adderall obtained licensure for Adderall XR. This is a newly formulated type of long-acting Dexedrine that is made up of four different salt compounds. These compounds would deliver steady and predictable levels in the bloodstream that would last throughout the day. For the right patient, Adderall XR proved to be a wonderful medication.
The decision by Canada to halt the sale of Adderall XR stems from the report of twenty sudden unexplained deaths of patients who were taking Adderall or Adderall XR since the licensing in 1994. The FDA in the United States was well aware of these cases. In 2004 the FDA reviewed these cases before approving the use of Adderall XR in adults. In response to the action taken by the Canadian government, the FDA released a Public Health Advisory stating that there are no plans to take any action on the use of Adderall XR. It detailed twelve cases of sudden unexplained deaths in pediatric patients, ages one-to-eighteen years, from 1999 through 2003. These patients were being treated with Adderall or Adderall XR.
Of the twelve cases reported, five occurred in patients with underlying structural heart defects such as abnormal valves or arteries, or abnormally thickened heart muscle. The other cases were difficult to interpret. They were associated with a family history of heart arrhythmias, death associated with heat exhaustion, dehydration and near drowning, very vigorous exercise, fatty liver and diabetes. Unusual and unexplainable levels of the drug were reported in several of the pediatric deaths. These toxic levels beg the question of possible drug abuse.
The FDA Advisory goes on to state, “When one considers the rate of sudden death in pediatric patients treated with Adderall products based on the 30 million prescriptions written between 1999 and 2003 (the period of time in which these deaths occurred), it does not appear that the number of deaths reported is greater than the number of sudden deaths that would be expected to occur in this population without treatment.” For that reason, the FDA has decided to take no specific action on the licensing of Adderall products, but continues to monitor the situation.
In our office, we have decided to follow the recommendations of the FDA. Whenever we evaluate a patient for possible ADD a detailed history is taken and a thorough physical examination is conducted. When it is decided to start a patient on ANY medication, it is understood that the patient is to have quarterly evaluations by the doctor, or no further prescriptions will be written. During the quarterly visit, we monitor the patient’s growth parameters, blood pressure and vital signs. We do a detailed review of systems, looking for any untoward affects. We feel confident that with this level of scrutiny our patients will be safe while on their ADD medication. We, too, will be closely following any new information that should arise regarding this matter.