Study Sparks Debate on Ritalin Use in Preschoolers

(HealthDay News) -- A new national study that raises the possibility of preschoolers with attention-deficit hyperactivity disorder taking Ritalin has sparked a debate over the safety and appropriateness of such a practice.

"This drug doesn't work as well in preschoolers as it does in older kids, and there are more adverse effects and a higher drop-out rate in this group," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "In addition, there is an explicit statement [in the study] saying that the size of this study is too small to conclude that this drug is safe and, to me, that is as important as anything."

The National Institute of Mental Health (NIMH), which funded the study, however, says the drug might be useful in certain severe cases of attention-deficit hyperactivity disorder (ADHD).

"Going into this, we had no data with which to know whether the medication was effective or safe, and what we know coming out of it is that there is some evidence of benefit in this young age group, but less than what we see with older children, and the risks are somewhat greater," said NIMH Director Dr. Thomas Insel. "We are recommending to clinicians and families that the drug should be considered as one of many options that can be used in very young children with severe ADHD, and I underline severe. If it's going to be used, it needs to be used carefully with careful monitoring," he added.

Others agreed that Ritalin should be considered on a case-by-case basis. "It is well known that ADHD has its onset usually between 3 to 4 years of age, so it is only reasonable if behavioral and psychosocial interventions fail that we consider the use of psychostimulants such as Ritalin, as this intervention is successful at least 70 percent of the time," said Dr. Jon A. Shaw, director of child and adolescent psychiatry at the University of Miami Miller School of Medicine. "It's a cost/benefit decision that parents have to judiciously consider, weighing the risk of side effects and the benefits of helping a child to control himself/herself."

Ritalin (methylphenidate) is used to treat ADHD but is not approved for children under the age of 6, although Insel said that about 1.2 percent of preschool kids are already receiving the drug. Such "off-label" prescribing is not illegal.

Even in older children, the drug has had its share of controversy. The U.S. Food and Drug Administration pediatric advisory committee recently met to consider whether ADHD drugs including Ritalin should carry a black box warning to highlight the possible risks of psychosis, mania and cardiovascular problems. In the end, the committee voted against a black-box warning but recommended the label use simpler language and include more information.
According to the Associated Press, about 8 percent of U.S. children have ADHD, including around 3 percent of preschoolers.

The study that sparked the latest controversy is the first, long-term government trial of Ritalin in preschoolers and is in the November edition of the Journal of the American Academy of Child and Adolescent Psychiatry.

Several of the study's authors have financial ties with companies that make the drugs.
The Los Angeles Times reported that the trial was initiated in response to the outcry that ensued when the Journal of the American Medical Association claimed that as many as 200,000 preschoolers were taking Ritalin off-label.

The trial involved 183 children with severe cases of ADHD who took Ritalin for about a year. Thirty percent of parents reported moderate to severe adverse events in their children, including emotional outbursts, difficulty sleeping, decreased appetite and irritability. About 11 percent of children dropped out because of side effects.

The preschoolers taking the drug also grew about a half inch less and gained about two pounds less than expected for their age.

Improvements in behavior were seen in children taking 7.5 to 30 milligrams daily, with the optimal dose being 14 milligrams daily. That is less than half the usual dose for older children.
The size of the study was a major sticking point for critics. "If you're worried about some serious adverse effects, you'd never see it in 183 kids," Wolfe said. "They specifically say this should be studied in at least 1,500 kids, which is seven times more than it was."

"Is there enough evidence for this drug to be approved for this group of preschool children for which it is currently not approved? The answer is clearly no. The authors themselves say no," he continued. "People should be extremely careful about giving this to young kids."

Insel said he suspected the drug's maker would not seek approval for this indication. "It's being used so widely, I don't know that they need to do any marketing," he added.
Insel also said he did not believe the study was that small and that, in fact, investigators had gone into the trial feeling that it would show that the drug should not be used. "The evidence does not bear that out," he said.

But long-term follow-up still needs to be done.

"What we don't know, and I think this is critical for parents, is what the long-term issues are," Insel said. "Are we altering brain development or is this a case in which the natural course of brain development has already been altered by a disorder, and we're in some ways mitigating those effects? We will need long-term follow-up, and that's in the works."

More information
The National Institute of Mental Health has more on ADHD.
http://www.dreddyclinic.com/findinformation/aa/
attentiondeficithyperactivitydisorder.htm

Health Tip: Take ADHD Medication as Prescribed

(HealthDay News) -- Medications used to treat attention-deficit hyperactivity disorder (ADHD) can be very effective if taken as prescribed by your doctor.
But these medicines can trigger serious side effects if taken by a person who does not have ADHD, or if you take more than what is prescribed.
Here are potential side effects of overdosing on an ADHD medication, courtesy of the Nemours Foundation:

• Tremors and shaking.
• Extremely high blood pressure and increased heart rate.
• Rapid breathing.
• Delusions, confusion, paranoia or hallucinations.

more info at: ADHD

Aplastic Anemia: A Rare Disease With a Better Prognosis

(HealthDay News) -- Aplastic anemia, a disease of the bone marrow, is a rare disorder in the United States. Only three of every 1 million Americans will be diagnosed with the condition this year, the National Marrow Donor Program reports.

Despite that rarity, this once-fatal disease has become far more treatable as physicians have honed in on practices that can prolong life and ease suffering.

And the effects of that research extend far beyond sufferers of aplastic anemia or other related bone marrow diseases. Insights gained from these diseases are also helping scientists learn about more prevalent health problems, such as heart disease or leukemia, researchers say.

Aplastic anemia occurs when bone marrow stops producing enough blood cells, said Katherine Baer, a patient information specialist for the Aplastic Anemia and MDS International Foundation Inc. Only about 1,000 new cases appear each year in the United States.

A related blood disorder, myelodysplastic syndromes, or MDS, occurs when the bone marrow begins producing poorly functioning or immature blood cells. About 20,000 to 30,000 new cases occur each year.

Doctors still aren't certain exactly what causes the diseases' onset, Baer said.

"They do think it can be caused; there are some toxins that may cause it, like benzene," Baer said. "But at least half the cases are of unknown cause." She added that radiation treatments for other diseases are another suspected cause.

The effects of aplastic anemia and MDS vary, depending on the type of blood cells lacking in the body, Baer said.

Red blood cells carry oxygen, and a shortage of those will cause fatigue and shortness of breath. White blood cells fight infection, so when the body lacks those cells, it is more likely to catch infectious diseases. Platelets cause clotting, and without those, people experience nosebleeds, bleeding gums and extended bleeding from cuts.

These diseases used to be killers, fatal within a year, said Dr. Richard Stone, clinical director of the Adult Leukemia Program at Harvard University's Dana-Farber Cancer Institute and an associate professor at Harvard Medical School.

"Now, people can be expected to live a long time in many cases," Stone said. "It's devastating if untreated but quite approachable if treated."

Baer and Stone said that while no breakthrough treatments have been developed, the available therapies are at the point where people can live with the disorders.

Most people with aplastic anemia will require multiple blood transfusions, which relieve symptoms by providing blood cells that the bone marrow isn't producing, Baer said. Symptoms also can be managed with immunosuppressive drugs similar to those used in AIDS treatment. The drugs suppress the activity of immune cells that are damaging bone marrow, helping the marrow recover and generate new blood cells, she said.

Antibiotics can be used to effectively fight off infections that take advantage of the disorder. And for a longer-term therapy -- or for people with severe aplastic anemia -- bone marrow transplantation is an option, but a limited one due to the difficulty involved in finding a matching donor.

Experimental treatments now being tested include growth factor drugs that may help stimulate the bone marrow to produce new blood cells; male hormones that also might boost blood cell production; and peripheral stem cell transplants. In that procedure, stem cells are taken from the blood of a donor, rather than from their own bone marrow, and transplanted into the patient, according to the Mayo Clinic.

"Twenty, 30 years ago, it [aplastic anemia] was fatal," Baer said. "Now, between the different treatments, 70 to 90 percent can live a long life. You have to continue to monitor your blood counts, and you are on some medication long-term."

Since these diseases involve damage to stem cells, research in this area could provide much insight into the potential of stem cells for treating other types of diseases. Stem cells have attracted much research focus due to their potential regenerative powers and ability to transform themselves into a host of different cells.

Bone marrow stem cells are the most primitive cells in the marrow, and from them, all the various types of blood cells are descended. Research also has shown that stem cells from bone marrow can give rise to non-marrow cells, which has led to federal funding to look into their usefulness in treating heart disease.

"It's very important to understand as much as possible about the bone marrow stem cell," Stone said. "What keeps it going, what causes it to become malignant? The more we understand about those things, the more we'll know about potential uses of stem cells."

More information
To learn more, visit the Aplastic Anemia and MDS International Foundation Inc.
and: http://www.dreddyclinic.com/findinformation/aa/anemiaaplastic.htm

Score Against Heartburn This Super Bowl Sunday

(HealthDay News) -- The Super Bowl-sized spread of food that football fans crave is no touchdown for the tummy, experts warn.

Indulging in party favorites like nachos, pizza, chili, wings and beer leaves many people open to being tackled by heartburn; most often caused by the reflux or backwash of acid from the stomach up in to the esophagus.

Dr. Stuart Spechler, professor of internal medicine in digestive diseases at the University of Texas Southwestern Medical Center at Dallas, offers some prevention and treatment plays that can help you do an end run around heartburn.

First up, try to avoid fatty foods. That can be tough because, "as a general rule of thumb, anything that tastes really good is likely to give you heartburn," Spechler said in prepared statement. "And the reason is the fat content. Fat does a lot of things that promote heartburn. It stops the stomach from emptying well, so now, you have more material in the stomach that's ready to reflux."

Some people try to reduce stomach acid by eating or drinking certain foods, such as milk. This usually doesn't work, Spechler said. He recommended medications such as H2 blockers, antacids, or proton pump inhibitors.

"If you know you're going to eat something that ordinarily gives you heartburn, there are medications that you can take before eating that food that might help," he said.
Histamine receptor (H2) blockers (for example, Pepcid and Zantac) slow the production of stomach acid and are generally available over the counter. Taking an H2 blocker a half hour before you eat may help prevent heartburn.

Antacids soak up excess stomach acid, but they don't prevent the stomach from producing more acid. You may be able to prevent heartburn by taking some antacid tablets to soak up acid currently being produced in the stomach, along with an H2 blocker to slow stomach acid production, Spechler said.

Proton pump inhibitors, such as Nexium, Prilosec or Prevacid, are the most powerful type of medication and are best suited for people with ongoing heartburn.

"They're very powerful at stopping the stomach from making acid, but it takes a number of hours or even days for them to reach their full effect. So, if you want to eat a pizza in the next half hour, it's not going to stop the acid that you're going to make in that time," Spechler said.
More information
The American Academy of Family Physicians has more about heartburn.