Practice in Clinical & Health Psychology
Concerns With ADHD Drugs

 

 

Information on the Risks of Treating ADHD
With Stimulant Medications

The first, and often heavily pushed, treatments for Attention Deficit Disorder is stimulant ADHD medication. The ADHD medications most commonly prescribed are Ritalin, Adderall and Concerta.

Parents of children diagnosed with Attention Deficit Disorder often feel overwhelmed and trapped in a very bad situation. No parent wants their child to fail in school. No parent wants their child to fall short of their abilities in life. Yet, many parents feel uneasy about giving their children ADHD medications. They might not be able to pinpoint exactly why they oppose the drugs but they just don't feel it is the right thing to do.

Adults diagnosed with Attention Deficit Disorder have a unique set of concerns; Will the ADHD medication cause sexual side effects? Dependency or addiction? Depression? Cardiac abnormalities?

Here you will find information about ADHD medications to help you to make an informed decision about using ADHD medications or giving your child ADHD medications. By clicking on the ADHD medication drug links at the top of this page, you can learn about each specific ADHD medication.

ADHD medication is an increasingly controversial area of treatment. ADHD medications do not always work, do not treat the core cause of Attention Deficit Disorder and could have long-term negative effects. Everyone considering an ADHD medication needs to be clear about the benefits as well as the potential side effects of ADHD medications to make an informed decision on using the ADHD medication.

While ADHD medications do work effectively for the majority of people, ADHD medications also have potentially harmful side effects.

Research is clear that stimulant ADHD medications can be helpful, at least in the short term. While ADHD medications can help people pay better attention and complete their work, the effect wears off when the ADHD medications wear off. ADHD medications do not increase knowledge or improve academic skills. ADHD medications only control the symptoms while the drug is in the body.

One study, conducted by Montreal Children's Hospital, looked at the long-term benefits of children using ADHD medications. This study concluded that, after five years, hyperactive children who used an ADHD medication did not differ significantly from children who had not received drug intervention.

The hyperactive children treated with Ritalin and other ADHD medications were initially more manageable but after five years, the children using an ADHD medication had the same degree of improvement and emotional adjustment as the control group of hyperactive children who did not receive ADHD medications.

Clearly, ADHD medication alone is not the answer.

For lasting improvement, many doctors advocate finding the underlying causes for Attention Deficit Disorder symptoms and dealing with those first before rushing into a course of ADHD medication. Behavioral and EEG biofeedback therapies, emotional counseling, a healthy diet and certain nutritional supplements can all effectively diminish the symptoms of Attention Deficit Disorder in most children.

Since children do not outgrow Attention Deficit Disorder, ADHD medication merely postpones dealing with the causes. Because of this, many health professionals believe that children displaying the symptoms of Attention Deficit Disorder should not be treated solely with ADHD medication. A growing number of health professionals, parents and educators believe that Attention Deficit Disorder is a disorder, but they do not agree that a long-term course of medication is the answer.

Take the time to thoroughly investigate the ADHD medications, their side effects and their benefits. With this ADHD medication information in hand, you can make an informed decision on using drugs, looking for alternatives to ADHD medications or developing a multi-faceted approach combining the two approaches.

 

  

NewsTarget  Originally published September 25, 2006

Canada Warns ADHD Drug Takers
Over "Psychiatric Events"

(NewsTarget)  In the wake of two dozen reported cases of mood, personality and psychological reactions that may be linked to ADHD drugs -- including agitation, hallucinations and three suicides -- Health Canada is revising it's prescribing and patient information for all such drugs in the country, considering adding "potential for psychiatric adverse events" to the warning labels.

Up to 5 percent of Canadian children are thought to have attention deficit hyperactivity disorder, a neurobiological condition diagnosed when children (and some adults) show signs of impulsive behavior, inability to focus, hyperactivity, and trouble with social interaction. Statistics show that more than 2 million prescriptions for ADHD drugs were written in Canada last year.

The review of the drugs and labeling should be completed by December, according to Health Canada spokesperson Paul Duchesne on Thursday.

"Canadians taking ADHD medication should consult with their doctor if they have any questions or concerns," he said, adding that patients should never discontinue their ADHD medication without consulting their doctor first.

Many in the field of psychology and child psychology have risen to defend the ADHD medications. Dr. Umesh Jain, head of the Canadian ADHD Resource Alliance, said a message of caution and prudence is nothing new.

"When medications are diverted and abused, they are potentially at risk for developing hallucinations, delusional beliefs, et cetera," added Jain, who works at the Center for Addiction and Mental Health and Toronto's Hospital for Sick Children. Jain also noted that the new ADHD medications are long-lasting, once-a-day medications that have "low diversion potential."

"If you were somebody who was going to use an excess amount, well beyond that of the range of the ADHD profile, yeah, they can potentially cause those problems," Jain said, adding that Health Canada's caution in alerting the population about all potential risks is partly because the medications are so widely used, but feared it may cause some patients and parents to worry needlessly.

However, since this is the second revision to ADHD drugs patient information this year -- the first in May warning about the heart-related risks associated with ADHD drugs -- critics of the medicines feel these revisions should be the first step in banning them.

"ADHD drugs are psychotropic substances that pose real dangers to the mental health of both children and adults," said Mike Adams, a natural health author and critic of the overmedication of children. "Even worse, the drugs are routinely prescribed for a so-called disease that is entirely fictitious. It was invented, promoted and sold to the public as a problem needing a chemical solution that just happened to be offered by powerful drug companies."

  

Ritalin and Cancer Risk

Randall Neustaedter OMD, LAc, CCH

In a surprising study conducted at the University of Texas, researchers have discovered that every child they tested who was taking Ritalin (methylphenidate) developed chromosomal aberrations that have been associated with an increased risk of cancer (El-Zein, 2005).

This study was stimulated by previous animal research that showed an increase in liver tumors in mice at high doses of methylphenidate (Dunnick et al, 1995). Laboratory studies have also shown chromosomal changes in both hamster (Gallaway et al, 1987) and human cells grown in cultures (Walker et al, 1977).

The Texas researchers tested 12 children before and three months after beginning a daily Ritalin prescription for treatment of ADH (Attention Deficit/Hyperactivity Disorder). Every child experienced an increase in genetic damage that is associated with the development of cancer after taking the drug. In the words of the authors, "In every individual examined, there was a statistically significant increase in every genotoxic endpoint analyzed… for each of the parameters tested."

The authors suggest that another drug, Adderall, is available for the treatment of ADHD, which is also an amphetamine-based drug like Ritalin. They then note that similar genetic damage has been observed in adult methamphetamine users (Li, 2003). They caution that children should be monitored for genotoxic effects of these drugs. Finally, they conclude, "the lack of research on the long-term effects of methylphenidate use in humans warrants great concern."

The HPA suggests that alternatives do exist for the treatment of attention problems in children. Parents do not need to risk the short-term or the long-term risks of Ritalin and other drugs used to treat ADD and ADHD. Holistic pediatric practitioners are well-versed in the use of nutritional supplements, lifestyle changes, homeopathic treatment, herbal approaches, cognitive therapy, and body work that will all have a significant impact on a child's ability to focus and concentrate.

 

 Biological Psychiatry, 2006 August 4. Pre-print release

Juvenile Administration of Methylphenidate
Attenuates Adult Hippocampal Neurogenesis

Lagace, D.C., Yee, J.K., Bolanos, C.A., Fisch, A.J.

Department of PsychiatryUniversity of Texas Southwestern MedicalCenter, Dallas, Texas.

 

BACKGROUND: The neural consequences of early-life exposure to methylphenidate (MPH; Ritalin) are of great interest given the widespread, and sometimes inappropriate, use in children. Here we examine the impact of juvenile MPH exposure on adult hippocampal neurogenesis.

METHODS: Rats received MPH (2.0 mg/kg, intraperitoneal, twice daily) or saline (SAL) during preadolescence (postnatal days 20-35). Hippocampal cell proliferation (Experiment 1), neurogenesis (Experiment 2), and stress-induced changes in cell proliferation (Experiment 3) were assessed at several developmental stages including adulthood.

RESULTS: Juvenile exposure to MPH did not alter proliferation at any developmental time point relative to control rats; however, exposure to MPH significantly decreased the long-term survival of newborn cells in adult rats, particularly in the temporal hippocampus. Although MPH-treated rats had higher levels of corticosterone after restraint stress, they did not show the expected greater decrease in hippocampal cell proliferation relative to control animals.

CONCLUSIONS: Early-life exposure to MPH inhibits the survival of adult-generated neurons in the temporal hippocampus and may reduce progenitor sensitivity to corticosterone-induced decreases in proliferation. These findings suggest that decreased adult neurogenesis is an enduring consequence of early-life exposure to MPH and are discussed for their relevance to humans.

PMID: 16893528 [PubMed - as supplied by publisher]

 

 

ADHD Medications Effective,
But May Also Stunt Growth

From: WebMD Medical News  05April2004

April 5, 2004 -- Treating attention-deficit/hyperactivity disorder (ADHD) with medication and behavioral therapy can provide lasting results, but the risks and benefits of those treatments may vary substantially over time, according to new research.

In a follow-up to a large study comparing ADHD treatments, researchers found that the initial edge that medications had over other forms of treatment, such as behavioral therapy, leveled off over time while the benefits of behavioral therapy remained relatively constant.

"Medication is still better in terms of symptom reduction than being assigned to behavioral treatment, but the large difference that we reported before has now shrunk by 50%," says researcher James Swanson, PhD, of the University of California Irvine.

In addition, the study showed that long-term use of medications commonly used to treat ADHD, such as stimulants, appeared to mildly stunt growth. Children on medication therapy may grow almost a half-inch per year slower than those children not on medication. Researchers aren't sure if the mild growth suppression is permanent. The authors say that children treated with medication may catch up over a period of time.

But researchers say those numbers don't tell the whole story. In fact, they published a second report in the April issue of the journal Pediatrics in order to explain their findings published in the same journal.

Explaining the Truth Behind the Numbers

In the study, researchers followed 540 of the original 579 children who participated in the National Institute of Mental Health Multimodal Treatment study of ADHD for 2 years.

In the first phase of the study, the children were assigned to one of four different treatment groups (medication alone, medication plus behavior modification therapy, behavior modification therapy alone, or a community comparison group) for 14 months. At the end of the first phase, the participants were free to change their treatment and were followed for an additional 10 months.

All four groups improved during the first phase, but the medication and combination therapy groups experienced a significantly greater reduction in ADHD symptoms.

Ten months after completing the initial phase, the study showed that the medication's group significant benefit in symptoms reduction declined over time while the benefits of other treatments remained consistent.

"At 24 months after the start of treatment, the effects of various treatments seem to be coming together," says Swanson.

But researchers say changes in medication use such as starting and stopping medication may explain the changes seen over time with the treatments.

"We don't think that treatments become ineffective over time," says Swanson. "What we see is that a lot of people stop treatment, and then the efficacy is not permanent and it tends to go away when the treatment stops."

Swanson says many of the children who were initially assigned to treatment with ADHD drugs stopped taking them after the first phase of the study, and many of those in the behavioral group started taking them during the follow-up period.

Further analysis showed that children who stopped taking their ADHD medications tended to have a greater reduction in benefits, children who went on medication showed improvement, and children who stayed with the same treatment stayed about the same, whether they were on medication or not.

ADHD Medications May Stunt Growth

The study also showed that children who took ADHD medications grew at an average of 5 centimeters per year compared with the 6 centimeters per year seen in unmedicated children.

Researchers say those findings are in line with previous studies that have shown similar short-term effects on growth. But this is the first major long-term study to show the effect for two years of using the drugs.

"We want to be cautious because we don't know if in the long run children might catch up or not," says Swanson. For example, he says that children using ADHD medications might only experience a delay in growth that only very long-term studies might be able to pick up.

Interestingly, researchers also found that unmedicated children with ADHD actually tended to grow taller than children without the condition, which suggests that any potential negative effect of ADHD medications on growth may be less obvious in these children.

"Whether that's going to outweigh the clear benefits that I think this study and many others have shown for using medication in the treatment of ADHD over the long-term is one of those things that we will have to continue to look at," says researcher Glen R. Elliott, MD, PhD, director of the Children's Center at Langley Porter, University of California, San Francisco.

Any ADHD Info Is Good Info

Experts say that although this study doesn't necessarily compare the effectiveness of one ADHD treatment versus another, the fact that it provides long-term data on the effects of treating children with ADHD is significant in itself.

"It is amazing that regardless of how common this condition is, and how often times young people are prescribed medicine for this, there really is such a paucity of long-term effectiveness or safety data," says Robert Findling, MD, director of child and adolescent psychology, University Hospitals of Cleveland.

Findling says this study may also help parents of children with ADHD weigh treatment options.

"Over time, if your child is doing well on [ADHD] medicines, the odds that they should continue on those medicines," says Findling. "It appears that kids who stay on medications do best over time, and with that comes risk of what appears to be risk of a potential for a slight reduction in growth velocity.

"Ultimately at this point, there is no right or wrong," says Findling. "But more important than anything else is that it provides valuable information for parents, physicians, and young patients that will help inform them, and that really ultimately is the answer."

SOURCES: MTA Cooperative Group, Pediatrics, April 2004; vol 113: pp 754-769. James Swanson, PhD, professor, pediatrics, University of California, Irvine. Robert Findling, MD, director, child and adolescent psychology, University Hospitals of Cleveland. Glen R. Elliott, MD, PhD, director, Children's Center at Langley Porter, University of California, San Francisco.

 

 Bugging Out. The Pesky Side Effects of Ritalin

From: Psychology Today, Sep/Oct 2006 page 33

Some kids will drive you mad without their Ritalin. But some kids are driven mad by their meds, at least temporarily. The FDA is now revising the labels on stimulants to warn that the pills can cause psychotic symptoms, even at normal doses. The side effects reportedly appear in up to 5 percent of children, and many sufferers complain of bug or worm infestations. They see the critters or even feel them under their skin. But why the delusions? And why these delusions?

Ritalin, cocaine, speed and caffeine all act similarly on dopamine in the brain, and each can cause psychosis. Two elements give the visions legs. First, uppers make your skin tingle, a suggestive sensation. Second, urbanization has estranged us from our buggy beginnings, making insects seem unnatural and enhancing the prevalence of parasite apparitions in psychiatric disorders.  Matthew Hutson

 

UM Study: Ritalin Use May Worsen Cocaine Abuse

BY CONNIE PRATER AND SHARI RUDAVSKY
cprater@herald.com

People who use cocaine regularly may have a harder time breaking the habit if they used Ritalin or the club drug Ecstasy in their youth, a University of Miami study suggests.

The number of U.S. children and adolescents who were prescribed Ritalin and other stimulants surged dramatically in the 1990s.

The study, conducted on laboratory mice, found that rodents given Ritalin and Ecstasy, then later cocaine, showed higher sensitivity to cocaine than those that hadn't been exposed to the first two stimulants.

''If they start using drugs, these guys that have been preexposed to Ritalin and Ecstasy may be more susceptible for relapse than others,'' said Yossef Itzhak, a UM professor of psychiatry and the lead researcher on the study.

But Itzhak noted the study did not mirror real life because the mice did not have Attention Deficit Hyperactivity Disorder, the condition for which Ritalin is normally prescribed. One other caveat: It's not clear how the relatively high doses of Ritalin he looked at for mice would translate into humans.

`WARNING SIGNAL'

''Higher doses may be much more dangerous than therapeutic doses,'' he said, adding that his study may be more relevant for those who abuse Ritalin than those who take it on a carefully monitored prescription basis. ``For Ritalin, caution should be used. For Ecstasy-using adolescents it's a warning signal.''

Itzhak and his associates will present the results on Wednesday in Bal Harbour during the 65th annual meeting of the College on Problems of Drug Dependence, a national group of more than 1,000 scientists.

Ritalin is a stimulant used to treat millions of children and adults diagnosed with ADHD, thought to occur when the brain fails to produce a sufficient amount of a neurochemical called dopamine. Ritalin provides the chemical stimulant the brain lacks.

In the 1990s, the number of U.S. prescriptions for Ritalin and similar drugs rose fivefold to nearly 20 million by 2000, according to IMS Health, a national prescription auditing firm. About 80 percent of the prescriptions are written for children diagnosed with ADHD.

COLLEGE STUDENTS

Moreover, this doesn't include an increasing number of college students abusing Ritalin for a high. The Partnership for Drug-Free America estimates that 9 percent, or 2.1 million teens, have taken Ritalin or similar drugs without a prescription.

''They trade it and they sell it,'' said Itzhak. ``It has so many characteristics of other types of stimulants.''

Ecstasy, or MDMA, is a methylated amphetamine that causes hallucinations. The Florida Department of Law Enforcement reported MDMA contributed to the deaths of 24 people statewide in 2002 and 37 the previous year.

According to the Partnership, about 1.1 million use Ecstasy on a regular basis.

Dr. Alan Singer, a South Miami psychiatrist who has treated adults and children with ADHD, said the UM study differs from earlier studies showing how children treated with Ritalin for ADHD have higher self-esteem in adulthood, and are less likely to abuse drugs than those diagnosed with ADHD and aren't treated.

Still, he acknowledged, ``The idea that stimulants predispose you to later substance abuse is something that clinicians have worried about for a very long time.''

CHANGES IN BRAIN

While Itzhak said that the exact mechanism behind his findings remain unclear, the use of these drugs does appear to produce long-term changes in the brain. Previous drug exposure sensitizes the regions of the brain associated with reward, he said.

''This is the million-dollar question, how to avoid or prevent changes in the brain so that they would not produce this factor for relapse and drug-seeking behavior,'' said Itzhak.

The study had three groups of 4-week-old mice -- those given Ritalin, those given the same dosage of Ecstasy and those given saline solution. They received one dose a day for seven days.

''We left them drug-free for one month with no treatment,'' Itzhak said.

The researchers then gave all three groups cocaine daily for seven days. There was no significant difference among the three groups in their sensitivity to the drugs. They waited another two weeks and gave each group a smaller dose of cocaine.

The Ecstasy and Ritalin groups showed very high sensitivity to the cocaine, Itzhak said, while the mice that had gotten saline solution showed little impact.

Although Itzhak looked only at cocaine, he said it was possible that his results might apply to other psycho-stimulants, such as amphetamines.

--------------------------------------------------------------------------------
Herald researcher Elisabeth Donovan contributed to this report.

 

While scientists clash over the dangers of ADHD drugs, the U.S. government does nothing to protect children

Since the Vioxx scandal broke in late 2004, most Americans are all too familiar with the idea that prescription drugs can be dangerous and even deadly. But how would America react if it were to discover that a class of drugs being primarily prescribed to children was also dangerous and sometimes deadly?

According to a May 2006 report by the U.S. Centers for Disease Control and Prevention, side effects and "problems" with widely prescribed Attention Deficit Hyperactivity Disorder (ADHD) drugs send 3,100 people to the ER every year -- 80 percent of them children.

"Problems" most often include overdosing or accidental use, and side effects can include chest pain, high blood pressure, rapid heart rate, stroke and sudden death. Between 1999 and 2003, 25 deaths linked to ADHD drugs were reported to the FDA, 19 involving children. In addition, 54 cases of other serious heart problems were reported, including strokes and heart attacks.

Considering that roughly 3.3 million Americans who are 19 or younger, and 1.5 million who are 20 and older, are currently taking ADHD drugs -- with those numbers constantly rising -- it is safe to assume that the number of ADHD-drug-related hospitalizations will also continue to increase. Given these revelations about the risky nature of ADHD drugs, one might wonder what the U.S. Food and Drug Administration (FDA) is doing to warn consumers of these popular stimulants.

In February 2006, an FDA advisory panel voted 8-7 in favor of including its most serious "black box" warning on ADHD drugs, but the very next month, a different FDA panel instead voted to put information on cardiac and other risks in a new, special "highlights" section of prescription drug inserts.

Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic, criticized the FDA's decision in the April 6 issue of the New England Journal of Medicine: "I believe that the appearance of information in the 'highlights' section of the drug label will have virtually no effect on prescribing practices." Think back to the last time you picked up a prescription from the pharmacy. Did you look at the information pamphlet inside the bag, or did you go straight for the pill bottle, assuming that your prescription was safe?

In a letter appearing in the same NEJM issue, the heads of the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association -- Dr. Thomas Anders and Dr. Steven Sharfstein -- contradicted Nissen's argument that a "black box" warning on ADHD drugs was necessary for patient safety: "We agree that patient safety is paramount and that the long-term benefits and risks of stimulant treatment are not known definitively, yet we are concerned that such a warning will discourage patients and their families from using effective treatment."

In his rebuttal in the April 6 issue, Nissen replies, "I strongly disagree. I cannot accept the paternalistic notion that patients and caregivers are better off without information about drug risks. The presence of a black-box warning and a mandatory patient guide would probably stimulate useful discussions among patients, parents, and physicians about risks. An appropriate warning might also slow the exponential growth in the use of amphetamines and similar stimulants, which has reached epidemic proportions in the United States, resulting in the treatment of nearly 10 percent of preadolescent boys."

The "exponential growth" Nissen refers to has garnered national attention in recent years, and has left many wondering what brought it about. Was there a sudden outbreak of ADHD in the past decade? Was there something in the water causing children to suddenly fall victim to this behavioral disorder? In September 2000, PBS Frontline ran a special called "The Ritalin Explosion," during which the show interviewed child psychologist Harvey Parker, co-founder of the non-profit organization Children and Adults with ADD (CHADD). Frontline asked Parker what had changed among the general public to bring about the rise in ADHD diagnoses and prescriptions for medical treatment.

Parker replied that "several things" caused the increase in ADHD drug prescriptions, including more parents having their kids examined, and doctors understanding that "medication was an appropriate treatment for ADHD, not a last-resort treatment, but in some cases, a first-resort treatment." Parker continued, "We realized that kids with ADHD don't have to stop taking medication when they become adolescents. We used to think that stimulant medication would stunt growth. We realize that that doesn't happen. So we continued prescribing medications to these children through adolescence."

 

ADHD "experts" are ignoring evidence of dangerous drug side effects and defending increasing prescription rates

Apparently, medicating kids from childhood through adolescence wasn't quite enough, though. "We also realized that children could take medication more than once a day. They can take it in the morning, in the afternoon and evening, and even late in the afternoon when they come home from school. ... So all these factors combined to cause a rise in the prescription rates of medication today," Parker said.

Note the lack of any indication that the higher prescription rate is a bad thing. Also note that a recent review of previous studies on whether or not ADHD drugs stunt growth concluded that the stimulants do, in fact, stunt growth, by an average of three-quarters of an inch and about 2 pounds of body weight for 10-year-old boys.

Essentially, kids are being massively over-prescribed ADHD drugs that come with possibly deadly side effects, and the government is doing little to nothing to warn parents of those dangers. However, it seems that yet again, it's the U.S. government that is dragging its feet to protect consumers -- and in this case, millions of children -- from dangerous medications.

In late May 2006, Health Canada issued warnings of heart risks -- including sudden death -- on all drugs used to treat ADHD. "The effects are usually mild or moderate, but in some patients, this stimulation may -- in rare cases -- result in cardiac arrests, strokes or sudden death," the agency warned. Health Canada issued the warning even though no deaths caused by ADHD drugs have been reported in Canada.

The FDA is being sluggish to issue warnings on the newest risks ADHD drugs pose to users, the majority of which are children. It forms committees such as the Drug Safety and Risk Management Advisory committee, which convened in February 2006, and the Pediatric Advisory Committee, which convened in March 2006 and was attended by FDA epidemiologists and physicians, as well as two representatives from Big Pharma, to discuss if and how patients should be warned about the dangers of ADHD drugs. Notably, both committees did not find the need for a black-box warning "warranted."

One might wonder why Canada -- which has suffered zero deaths because of ADHD drugs (thus far) -- found the need for a warning "warranted" and acted quickly to issue it, while the United States, which has suffered 25 deaths (19 involving children) because of ADHD drugs, has effectively done nothing to warn its citizens of the dangers of such medications.

While the United States has a few lobbyists on the side of public health arguing for strong warnings and patient education on ADHD drugs, it seems no one has considered alternative approaches such as the possibility of preventing the development of ADHD in many cases through better diet (e.g., more fruits and vegetables, more omega-3 polyunstaurated fats, less processed foods, less high fructose corn-syrup, etc.), less television-driven over-stimulation in early childhood, and parenting that focuses more on teaching children to be less dependent on external stimulation in play or alternative treatment such as EEG biofeedback that can actually “cure” the underlying developmental brain dysfunction.

 

 US Panel Urges Heart Risk Warning on ADHD Drugs


Reuters Health Information 2006. © 2006 Reuters Ltd.

 

GAITHERSBURG, Md. (Reuters) Feb 09 - Prescription drugs to treat attention deficit disorder should come with strong 'black-box' warnings that they may increase the risk of heart problems in some patients, a U.S. advisory panel said on Thursday.

The Food and Drug Administration committee voted 8-7 in favor of the warning, with one abstention. Fifteen members also voted to recommend the drugs, which include Novartis AG's Ritalin and Shire Pharmaceuticals Group Plc's Adderall, be dispensed with a patient-friendly guide that explained possible side effects.

 

ADHD Drug Warnings Could Cause Undue Worry: Doctors


Reuters Health Information 2006. © 2006 Reuters Ltd.

BOSTON (Reuters) Mar 21 - New warnings that may be added to drugs for attention deficit disorder, or ADHD, could have a chilling effect on prescribing habits of doctors, cut sales of the drugs and create unnecessary fear in the public, some experts say.

This week a U.S. Food and Drug Administration advisory panel will meet to discuss potential cardiovascular and psychiatric side effects of drugs such as Novartis AG's Ritalin, Johnson & Johnson's Concerta, Shire Pharmaceuticals Group Plc's Adderall and Eli Lilly & Co.'s Strattera.

The FDA panel, a group of outside experts, will also consider the possible increased risk of suicidal thinking with Cephalon Inc.'s experimental treatment Sparlon, a drug containing the same ingredient as its narcolepsy treatment Provigil. Cephalon's stock has fallen 11 percent since March 15, when it was revealed that Sparlon's risks would be scrutinized during the discussion of ADHD drugs and suicide risk.

A different FDA advisory panel that met last month recommended that the ADHD drugs carry black box warnings -- the most serious possible -- about the potential risk of sudden cardiac death and heart attack. Adderall already carries such a warning.

The panel that meets Wednesday will consider whether and how to strengthen warnings about the cardiovascular risks, as well as psychiatric risks such as psychosis and mania.

FDA officials say they are waiting to hear from the panel before deciding whether new warnings are needed.

"The reaction at the FDA is more emotional and political than scientific," said Dr. Joseph Biederman, chief of pediatric psychopharmacology at Massachusetts General Hospital and Professor of Psychiatry at Harvard Medical School. "These drugs in healthy people have an extraordinary record of safety."

"The vast majority of the risks are known, understandable and controllable," said Dr. F. Xavier Castellanos, professor of Child and Adolescent Psychiatry at New York University School of Medicine and author of "Stimulant Drugs and ADHD Basic and Clinical Neuroscience."

"If they put black boxes around everything, they will cease to have any relevance," he said.

Attention deficit hyperactivity disorder is characterized by impulsivity, lack of focus and hyperactivity. Every month U.S. doctors write 2 million prescriptions for ADHD drugs for children and another 1 million for adults.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a member of the panel that recommended stronger heart risk warnings, said last month he wanted a doctor's hand to "tremble" a little before writing a prescription for ADHD drugs.

Some analysts think strengthening of safety warnings on the drugs is inevitable.

"The FDA clearly wants to make material changes to the labeling for the ADHD class of drugs," said Marc Goodman, an analyst at Morgan Stanley. Goodman recently cut his growth rate prediction for the ADHD market to 5 percent from 7 percent for the 2006 to 2010 period.

The debate over ADHD drugs comes on the heels of a similar debate over the use of the SSRI class of antidepressants, which some claim increase the risk of suicidal thoughts among adolescents. In 2004 the FDA required antidepressant makers to include that risk in a black box warning.

"That hasn't helped anyone much," said Barbara Ryan, an analyst at Deutsche Bank. "We're in an environment now where labels are becoming so riddled with warnings that people don't know what to do."


ADHD Drugs Do Not Increase Risk for Later Substance Abuse

Stimulant medications used to treat attention deficit hyperactivity disorder (ADHD) in children do not lead to substance abuse later in their lives, according to a Medical College of Wisconsin study released in 2003 and published in the journal Pediatrics.

The research findings are among the most recent in a growing body of evidence, supported by results from ten previous studies elsewhere, indicating that ADHD drugs do not "sensitize" children to drug use in general.

"We found that maintenance on stimulant medication in childhood does not increase the risk for substance abuse in adolescence and young adulthood in individuals who have ADHD," said Mariellen Fischer, PhD, Medical College Professor of Neurology and one of the principal investigators for the study.

Most research suggests that people with ADHD who are not treated are actually at increased risk for substance abuse compared to people without ADHD, Dr. Fischer said, in great part because ADHD impairs coping abilities, affects self esteem and emotional stability, and diminishes focus and capacity to learn and perform both academic and life skills.

Since stimulant drugs help control ADHD symptoms, it appears they also provide some protection against substance abuse. Dr. Fischer noted that the "sensitization hypothesis" connecting the use of prescribed drugs to substance abuse is by no means proven, and not just as it relates to ADHD drugs.

"There is some evidence for that hypothesis in animals," said Dr. Fischer. "There is no evidence for that hypothesis in humans. The research that has been done in humans that has appeared to support that hypothesis is all methodologically flawed and fails to take into account some of the variables that we in fact controlled for in our research study."

Study Finds No Association

"There is no evidence that taking medication for ADHD makes you more likely to take illicit drugs later on in life," said Dr. Fischer. "There is no evidence that it makes you think, 'Oh, I'll cure a problem by popping a pill,' and there's no evidence that taking the medication somehow sensitizes your brain to make it more likely to become addicted to substances if you happen to try them later on in life."

The Medical College study took 13 years to complete, beginning with two groups of subjects ranging in age from 4 to 12 years. Researchers compared 158 children referred to a neuropsychology service for hyperactive children at Children's Hospital of Wisconsin to a control group of 81 children from Milwaukee. Standard tests were used to diagnose ADHD in the hyperactive children.

In follow-ups conducted when the children reached a mean age of 15 years and again when they were at a mean age of 21, the study participants and their parents were interviewed and asked if the subjects had ever used any alcohol, marijuana, cigarettes, cocaine, hallucinogens, hashish, or unprescribed stimulants, tranquilizers or sedatives.

After determining which of the ADHD children had been treated with stimulants and how long they had been on these medications, a statistical analysis of the data compared later drug use among three groups: children who did not have ADHD, children with ADHD who had not been treated with stimulants, and children with ADHD who had been treated with stimulants.

No association was found between the use of stimulant drugs to treat ADHD and later drug use, even for the children who had been on stimulants for relatively long periods of time. The only exception was a slight increased risk for treated ADHD children to try cocaine, but just once, while in high school.

Dr. Fischer said that that there are "strong reservations" about that conclusion, however, as subsequent analyses showed that the elevated risk was a function of severity of the ADHD and associated conduct disorder rather than the stimulant medication treatment.

More Cases, More Prescriptions

As the number of children diagnosed with ADHD has grown, so has the use of drugs to treat them. Studies reported by the National Institutes of Health show that as many as 7.3% of school children may now be taking stimulants to manage ADHD-related symptoms.

Those symptoms include impulsivity, overactivity or difficulty controlling activity so that it is appropriate to circumstances, and inability to focus attention.

Stimulants have been the most commonly prescribed drugs used to treat ADHD. In the majority of cases, Dr. Fischer said, children with ADHD benefit significantly when stimulants or other appropriate medications are incorporated into treatment. The drugs can diminish impulsive behaviors, improve attention to tasks at hand, and aid working memory and in some instances coordination and motor control.

Given the expanding role of ADHD drugs, accurate assessment of risks related to their use is important to more and more parents and others who ponder treatment options for children in their care.

"Having ADHD increases the risk for substance abuse," said Dr. Fischer. "That's very clear. What's interesting is that the gateway drug is not marijuana, as many people might think. It's nicotine.

"I tell parents that there is no research evidence that using the medications to treat ADHD places their children at risk for later substance abuse and that there is evidence that the medications actually help to decrease the risk for substance abuse."

Dan Ullrich
HealthLink Contributing Writer

For more information on this topic, see the HealthLink articles One in Every Classroom: Kids with ADHD Struggle to Make the Grade and Newly-Available Drug Shows Promise for ADHD Symptoms.

Article Created: 2004-02-13
Article Reviewed: 2004-02-13

 

 

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