ADD and ADHD Drugs: FDA’s Black Box Warnings and Side Effects

U.S. physicians write millions of antidepressant prescriptions per year to patients under the age of 18 and even more for adults.

In 2004 the US Food and Drug Administration (FDA) directed the manufacturers of all antidepressant medications to add a “black box” warning that describes the increased risk of suicidal thoughts and behavior in children and adolescents given antidepressant medications. A “black box” warning is the most serious warning placed in the labeling of a prescription medication.

Since then there have been Black Box Warnings on many other medications for adults as well. They include the ADHD drug, Strattera warning that severe liver damage may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients; and then additional warnings for Strattera due to findings in clinical trials linking the drug to suicidal thoughts and behavior as well as agitation and irritability.

In 2005 the FDA’s website announced the possible safety concerns with methylphenidate drugs (central nervous system stimulant). Psychiatric adverse occurrences were linked to Concerta, Ritalin and other drugs used to treat children diagnosed with ADHD (Attention Deficit Hyperactivity Disorder) such as visual hallucinations, suicidal ideation, psychotic behavior and aggression or violent behavior. The FDA announced its intention to make labeling changes and examine other stimulant drug products approved for treatment of ADHD.

A major study questioning the effectiveness of ADHD drugs was performed and published by The Drug Effectiveness Review Project of Oregon State University. The researchers reviewed 2287 studies, virtually every study ever done on ADHD. Their finding were that there is little evidence that the drugs used to treat ADHD actually work or are safe in the long term or that they even help school performance.

Also in 2005, the FDA ordered that “black box” warnings be placed on a commonly prescribed ADHD drug, after clinical trials linked the drug to suicidal thoughts and behavior. The FDA indicated that the new warning stems from an ongoing review of all ADHD drugs and their possible association with suicide.

In the same year, the United Nations Committee on the Rights of the Child, issued a strong warning against falsely labeling youth with the psychiatric diagnosis of ADHD and administering powerful ADHD-drugs. In its Concluding Observations on reports by Australia, Finland and Denmark the Committee expressed concern that “ADHD and Attention Deficit Disorder (ADD) are being misdiagnosed and therefore psycho-stimulant drugs are being over-prescribed, despite growing evidence of the harmful effects of these drugs.”

In 2006 an advisory committee to the FDA requested that the FDA issue a Black Box warning on drugs prescribed to treat ADHD. The recommendation followed evidence that these drugs are linked to numerous deaths, heart attacks and strokes.

Shortly thereafter two FDA advisory panels held hearings into the risk of stimulants and another new ADHD drug called Sparlon. Between January 2000 and June 30, 2005 the FDA had received nearly 1,000 reports of kids experiencing psychosis or mania while taking the drugs. The first panel recommended stronger warnings against stimulants. The second committee recommended not to approve Sparlon.

The drug companies make millions, no billions of dollars on these drugs. If you wouldn’t send your child to a pusher on the street, then don’t give them these pharmaceutical drugs that you now know has proven to be harmful.

Based upon these proven studies medicating a child should not be the solution to the child’s difficulties with study or life. There are alternative solutions. See the recourses to your right.

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