By ANDREW BRIDGES, Associated Press Writer2 hours, 38 minutes ago
A federal health official said Thursday that there was a strong possibility that popular drugs like Ritalin used to treat attention deficit hyperactivity disorder may be linked to the deaths of 25 people.
"There's smoke. Does that represent a fire?" asked Dr. David Graham of the Food and Drug Administration.
To find out, an FDA advisory committee considered how best to study whether the popular drugs increased the risk of death and serious injury.
"We wouldn't be going through this exercise if we didn't think there was a real possibility of increased risk," Graham told reporters.
Further studies would examine the incidence of sudden death and serious health problems, including stroke and heart attack, among some of the millions of children and adults treated each year with the drugs. That could lead to new warning labels.
The deaths occurred between 1999 and 2003, according to an FDA report. Nineteen of them involved children. The report also detailed 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia, in adults and children being treated with ADHD drugs.
Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension.
The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate.
The FDA said it has tallied an additional 26 deaths between 1969 and 2003 in ADHD patients involving death by suicide, intentional overdose, drowning, heat stroke and from underlying disease.
The FDA's Drug Safety and Risk Management advisory committee is reviewing different ways to study whether the deaths are linked to use of the drugs. The few studies that have looked at longer-term use of ADHD drugs provide little information on those risks, the FDA said.
Analysis of the reports of death and injury suggests a possible link between the drugs and cardiovascular problems, the FDA's Dr. Kate Gelperin told the panel. But the link is not conclusive, nor is it clear whether there is an increased incidence of death or serious injury among people treated with the drugs, she added.
That, Gelperin said, "is really a question we'd like to have answered."
An FDA review found fewer than one case of death or serious injury per 1 million ADHD drug prescriptions filled, with one exception: 1.79 cases per million of nonfatal cardiovascular or cerebrovascular problems in adults treated with amphetamines.
Currently, about two million children and one million adults are prescribed ADHD drugs each month, the FDA's Dr. Andrew Mosholder said. Adult use alone grew 90 percent between March 2002 and June 2005, he said.
Sales of ADHD drugs increased to $3.1 billion in 2004, from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.
That stepped up use could spell increased risk.
"Because adults have a higher risk of heart disease and stroke to begin with, any increase in risk caused by these drugs could affect a large number of people," Graham said.
The FDA's Canadian equivalent, Health Canada, briefly pulled the ADHD drug Adderall XR from the market last year. A Canadian panel eventually concluded there was inadequate evidence of increased harm from the drug. The FDA reached a similar conclusion at the time.
Adderall is made by Shire Pharmaceuticals and Ritalin is made by Novartis Pharmaceuticals Corp. Various other companies make generic versions of Ritalin as well.
Sen. Chuck Grassley, R-Iowa, criticized the FDA's pace in studying the issue earlier this week.
Comment: Why risk the side effects that drugs create. A natural approach that works extremely well is EPA/DHA Omega 3 fatty acids, especially the DHA portion and the trace mineral Zinc.
DHA
NEW YORK, NY. Dr. Barbara Levine, Professor of Nutrition in Medicine at Cornell University, sounds the alarm concerning a totally inadequate intake of DHA (docosahexaenoic acid) by most Americans. DHA is the building block of human brain tissue and is particularly abundant in the grey matter of the brain and the retina. Low levels of DHA have recently been associated with depression, memory loss, dementia, and visual problems. DHA is particularly important for fetuses and infants; the DHA content of the infant's brain triples during the first three months of life. Optimal levels of DHA are therefore crucial for pregnant and lactating mothers. Unfortunately, the average DHA content of breast milk in the United States is the lowest in the world, most likely because Americans eat comparatively little fish. Making matters worse is the fact that the United States is the only country in the world where infant formulas are not fortified with DHA. This despite a 1995 recommendation by the World Health Organization that all baby formulas should provide 40 mg of DHA per kilogram of infant body weight. Dr. Levine believes that postpartum depression, attention deficit hyperactivity disorder (ADHD), and low IQs are all linked to the dismally low DHA intake common in the United States. Dr. Levine also points out that low DHA levels have been linked to low brain serotonin levels which again are connected to an increased tendency to depression, suicide, and violence. DHA is abundant in marine phytoplankton and cold-water fish and nutritionists now recommend that people consume two to three servings of fish every week to maintain DHA levels. If this is not possible, Dr. Levine suggests supplementing with 100 mg/day of DHA.Levine, Barbara S. Most frequently asked questions about DHA. Nutrition Today, Vol. 32, November/December 1997, pp. 248-49
Zinc
A new study has found that children with attention-deficit hyperactivity disorder (ADHD) may benefit from taking zinc supplements.
The study, published in the April issue of BMC Psychiatry, followed 44 children with the disorder and found that those on zinc saw greater improvements in behavior than those who were not given supplements.
NSI Omega 3 Fatty Acids
NSI L-Optizinc 30 mg of Zinc
CW
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