Vyvase is expected to stop the potential for abuse by individuals who snort or inject crushed pills. The newly developed drug will be listed as a Schedule II drug, a category including cocaine, methadone, methamphetamines, and other ADHD medicines such as Adderall and Ritalin. Vyvanse will carry a “black-box” warning because of safety concerns related to amphetamine abuse, as well as the risk of sudden death in patients with heart defects.

The FDA approval of Vyvanse took place in the same week when the agency required manufacturers of other ADHD drugs to warn patients and parents of potential mental and heart problems associated with these medications in a small percentage of users.

FDA statistics indicate that ADHD affects about 3 to 7% of schoolchildren and 4% of adults. The principal symptoms are hyperactive behavior, difficulty paying attention, and problems with impulse control. Medications approved to treat ADHD have major benefits for many patients but for some, they can also pose serious risks.

New warning instructions required for ADHD medications will be included for Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin, and Strattera.  It is hoped these new cautionary guidelines will not keep people who need these drugs from taking them.

Sources:  Yahoo News; Medical News Today

My son at age 8 could easily have been labeled a child with attention deficit disorder (ADD or ADHD) — a term not widely used in the late 1970s. His third grade teacher often sent me notes about his daydreaming or doodling in class. He was never placed on medication such as stimulants or antidepressants to influence his behavior. Away from school, absorbed in his own interests, he was clearly able to focus on what he liked to do. It took several years of mediocre grades before he was able to see the value of academic achievement.

My daughter came into her own in high school, when we enrolled her in a parochial school. The smaller school with a female-only student body and many extracurricular activities helped her learn to excel and to develop leadership skills.

After high school graduation, both youngsters were accepted at top colleges in California and have excelled in their post-graduate careers. My daughter is now in a doctoral program while working full-time as a high school vice principal. My son is a successful entrepreneur and computer programmer. Our family was fortunate. In some cases, a child’s early problems can extend into adulthood and without proper treatment, adversely affect the individual’s work and personal life.

 My point is to not be too hasty in putting your child on drugs, unless there is truly a problem that cannot be dealt with through other resources. If your child is quite inattentive, hyperactive and/or disruptive, some behavior modification classes or techniques might be helpful initially. A good child/adolescent psychiatrist can help you discover the root of the problem, and medications can be prescribed when needed. Work closely with teachers, school counselors or administrators and your child’s physician to ensure that appropriate medication or other treatment is used.

My account is based on my perspective as a parent, teacher, and health care professional. Here are some wonderful resources from an authority in the field to help guide you: 

I heard recently from Mohab Hanna, M.D., who visited my blog. Dr. Hanna is Board-certified in Child and Adolescent Psychiatry. His medical training was completed at the prestigious Johns Hopkins University School of Medicine. You can go to his blog (impressive!) at http://www.add-adhdtreatment.blogspot.com/. I found his initial entry to be especially helpful. Here are some highlights from Dr. Hanna’s entry of February 2, 2007:

AD/HD Medications:  What is a Parent to Do?”

 “A thorough evaluation is the first and most essential step in the process. It is impossible to treat any condition without knowing what you are treating. It is not prudent to ‘try a medicine to see if it works.’ That is an inappropriate way to proceed and can actually be harmful. Many children who appear to have some ADHD symptoms actually have a different condition, such as anxiety or depression. Furthermore there are some kids who have anxiety in addition to the ADHD. In either scenario, it is essential to determine the diagnosis prior to initiating any kind of medication trial…

“…Every medication has potential side effects. It is important to understand the different potential negative effects. In order to proceed with a medication trial, the potential benefit should outweigh the potential negative effects. Once the diagnosis of ADHD has been established and it has been determined that the potential benefit outweighs the potential negatives, the parents need to understand the risks of not treating the ADHD. Many studies have been conducted to examine the consequences of untreated ADHD. It is clear that there are numerous potential consequences such as academic failure, peer rejection, depression, accidents, substance abuse, etc…These consequences are significant and are typically not transient; they tend to continue to manifest into adolescence and adulthood.”

Dr. Hanna has also written a book titled Making the Connection: A Parent’s Guide to Medication in AD/HD.

“My goal with the book and the blog is to empower patients to be proactive in the decisions that are made,” says Dr. Hanna. “I also hope to provide them with balanced (non-marketed), unbiased information.” Dr. Hanna lives in Maryland and may be reached by telephone at 410-583-2623, ext. 3, or fax at 410-583-2949.

Source:  Dr. Mohab Hanna;

Psychiatrists urged the FDA to carefully consider a previous proposal to include the strongest warnings about heart attack, hallucinations and other potential risks. These adverse events believed to be associated with the drugs are seen in only a small numbers of patients.

Mental health advocates emphasized that leaving conditions untreated in children who need these medications could be equally as risky as the potential cardiovascular and psychiatric risks a few might encounter from their use. The likely outcome is that stronger wordings of potential adverse effects will be included, but a black box warning will be avoided.

Source Article

Most doctors who treat patients with stimulants such as Ritalin or Adderall say the risk for cardiac problems is “remote.” Out of the 2.5 million children and 1.5 million adults on stimulants, it is estimated that a handful of them will die suddenly each year, whether taking the drugs or not.

 Psychiatrists and cardiologists agree, however, that people with high blood pressure, heart murmurs, or other cardiovascular problems should be cautious in using these drugs. If their physician feels there is sufficient risk, they should taper off the drugs or reduce their dosage.

Patients should ideally be screened for potential problems before receiving prescriptions for these drugs, according Dr. James Waxmonsky, a psychiatrist at the University at Buffalo, New York.

Adults with high blood pressure, high cholesterol, a family history of heart disease, and those who smoke should be concerned about being on stimulants. If these risk factors can be eliminated or stabilized, using ADD medications would be more advisable. Certainly, patients with these medical problems should be closely monitored while taking stimulants.

William Pelham, a psychiatrist at the University at Buffalo who studies psychosocial treatments for attention-deficit disorder, points out that some children would benefit more from an intensive summer-long course of behavior modification. He indicates that most parents don’t even hear of these alternatives to medications.

Many adults feel that stimulants help them to lead a more normal and productive life. These individuals plan to continue on the drugs, despite any small risks they might be taking.

Source:  New York Times (2/21/06); Benedict Carey, reporter

An FDA panel recently voted 8-7 to recommend written guides to patients and to require that prominent, “black box” warnings be placed on drug labels. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and member of the panel voiced “grave concerns” about the harm these drugs may cause. The vote took place after FDA medical officers described reports of 25 sudden deaths, mostly children, among those taking these stimulants.

A biostatistician on the panel went so far as to say that stimulants might be more dangerous to the heart than the painkiller Vioxx, withdrawn from the market in recent years. Some physicians believe the drugs may increase risks of strokes and serious arrhythmias in children and adults, although the risk of heart disease is small in childhood. All panel members agreed that parents of children with known heart conditions should consult their physicians about the use of such drugs.

Ritalin has been marketed since 1955. Dozens of studies have shown it to be safe and effective, although these studies may not have continued long enough to determine risks of long-term use. The soaring popularity of these medications warrants close study as to their potential risks to the heart. Preliminary analysis suggests that heart risks may increase two-fold. With the increasing use of these medications in adults, this data may be more significant for them.

Panel members were deeply divided as to relative risks and benefits of stimulants. Psychiatrists and psychologists who treat patients with attention deficit disorder and hyperactivity disagreed on whether a strongly worded warning was warranted. The director of the Center for Children and Families at the State University of New York voiced the idea that a black-box warning might prompt families to explore behavioral treatments as alternatives to drugs – “a very good outcome for kids with ADHD and their families.” Other FDA officials expressed concern about scaring away many from needed treatment and minimizing the benefits of these drugs. They were unwilling to “sensationalize what is a very low-probability event.”

In March, the FDA will convene a committee made up primarily of pediatricians and psychiatrists on these issues. These clinicians are expected to voice support for continued use of stimulants and be reluctant to frighten patients with black box warnings. Pharmaceutical company representatives agreed to cooperate with the FDA on any label changes.

Sources:  San Francisco Chronicle, 2/10/06, Gardiner Harris, New York Times reporter; New York Times editorial (2/12/06)