Articles filed under 'ADHD'
The FDA recently approved a new amphetamine-based drug for hyperactivity disorder that will be harder to abuse than older stimulants, according to pharmaceutical company Shire. Vyvanse remains inactive until swallowed, after which it gradually releases its active ingredient d-amphetamine. It is activated after coming into contact with enzymes in the digestive tract.
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
February 27th, 2007
Pharmaceutical companies who make Ritalin, Adderall, Strattera and other ADHD drugs have been advised to give patients and parents additional warnings about the potential for serious psychiatric and heart problems. Patients would be given a 2-page medication guide with each new prescription.
Drug companies are expected to comply with the new requirement within 30 days. The announcement covers 15 drugs, including those offered in extended-release, patch and chewable versions.
Serious side effects for ADHD drugs are rare. However, the new warnings advise calling a physician immediately in case of chest pain, shortness of breath, fainting or hallucinations. A sudden change in behavior should also be noted and promptly reported.
Of the 3.3 million children taking ADHD medications, more than 2,500 went to emergency rooms in 2004. About a fourth of them had serious heart or blood pressure problems, according the Centers for Disease Control. Of the 25 deaths thought to be linked to the drugs, 19 involved children. In the 54 patients who experienced serious heart problems, some had prior heart conditions.
Proposed guidelines are to state that these amphetamine-based drugs have been linked to stroke and heart attacks in adults and sudden death in patients with heart problems or defects. A few children and teens reported hearing voices, growing suspicious or becoming manic while on ADHD medication. About 1 child in 1000 may experience hallucinations.
It is vital that patients give doctors a full history of cardiovascular or mental problems. In addition, they should make it known if they take antidepressants, seizure medications or blood thinners. The FDA emphasizes that persons with heart disease, blood pressure problems, hyperthyroidism or glaucoma should not take ADHD medications.
The FDA emphasizes that new requirement for expanded warnings is precautionary and should not discourage patients from taking these drugs, which are safe in appropriate patients.
Source: San Francisco Chronicle; Feb. 22, 2007 (article from Baltimore Sun)
CNN.com
February 24th, 2007
Neither of my two children in public schools in the 1970s gave stellar performances. I knew that both were bright. Yet, their elementary school report cards failed to reflect their intelligence. My husband and I helped them with homework, gave them outside tutoring, and even moved them to a different elementary school where test scores were better. In the summers I gave my daughter and son “homework” of my own, with math and language drills and assigned book reports. My eight years as a public school teacher before my younger child was born motivated me to supplement their studies.
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;
February 18th, 2007
An FDA advisory panel debated the issue on whether a “black box” warning should be placed on drugs such as Ritalin, prescribed for hyperactivity and attention deficit disorder. Up to 3.3 million Americans under the age of 20 take ADHD medications such as Ritalin, Adderal and Straterra.
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
March 31st, 2006
Phones are ringing constantly in many psychiatrists’ offices. Patients are worried about their own or their child’s treatments for attention-deficit disorder with a stimulant such as Ritalin. Since an FDA panel voted 8-7 recently to put a block-box warning label on each prescription bottle, patients on stimulants are exhibiting high anxiety.
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
March 24th, 2006
If your child has been labeled “hyperactive” by a teacher, you might think twice before resorting to a drug such as Ritalin to improve performance in class. Stimulants such as Ritalin, Concerta and Adderall are the most widely prescribed medications for childhood behavioral problems. Some 2.5 million children and 1.5 million adults are taking them for hyperactivity or attention deficit disorder (ADD or ADHD).
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)
March 19th, 2006