Attention Deficit Hyperactivity Disorder (ADHD) is a diagnosis applied to patients who exhibit the symptoms of inattention and restlessness, which can lead to poor performance in school, misbehavior, and drug abuse. The diagnosis has long been controversial in the US and is not accepted in some other countries. Despite this controversy, prescriptions for ADHD drugs have increased dramatically in recent years, particularly for adults and for children aged 2 to 4. The ADHD drug claim is that stimulant drugs can facilitate focus and lengthen attention spans in both children and adults.

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On March 22, 2006 the FDA’s pediatric advisory committee voted to recommend a less stringent warning of cardiovascular risks on all drug labels and package inserts for ADHD drugs and the FDA is moving to accept the second recommendation. This reversed a February 9, 2006 FDA subcommittee’s recommendation to place a black box warning on such drugs. (The black box warning is the highest level of warning required by the

Attention Deficit Hyperactivity Disorder (ADHD) is a diagnosis applied to patients who exhibit symptoms of inattention and restlessness that can lead to poor performance in school, misbehavior, and some claim, eventual drug abuse. The diagnosis has long been controversial in the US and is not fully accepted in some other countries. Are these symptoms really symptoms of “a disorder,” or are they symptoms of a variety of physical and emotional/behavioral issues? Nay sayers continue to criticize the diagnosis because no measurable physical symptoms or any cause for the claimed disorder have ever been identified. The ADHD drug claim is that they can facilitate focus and lengthen attention spans in both children and adults.

Suffered harm from an ADHD Drug? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.

Critics argue that even if a single disorder exists the dangerous drugs used to treat it are being grossly over prescribed when alternate, effective, and safe cognitive/behavioral therapies are available. Despite this controversy, prescriptions for ADHD drugs have increased dramatically in recent years, particularly for adults and for children aged 2 to 4.

In 2008, the controversy about ADHD medication continues. The American Heart Association has angered ADHD drug manufacturers by recommending doctors take more care in prescribing the medication, and a Senate committee is investigating the drug industry for conflicts of interest created by its payments to researchers who recommend psychiatric drugs and to the doctors who prescribe them.

ADHD stimulant drugs have long been connected to heart problems. The FDA has required warnings about these effects to be placed on ADHD drugs but has refused to issue its highest level of warning, a black box warning, on most of these drugs. In April 2008, the American Heart Association took an unusual action and recommended that all children being considered for stimulant drugs to treat ADHD should be given an EKG (electro-cardiogram) and that a complete family history of heart disease should be taken before such a drug is prescribed. The Association also recommended that all children currently taking ADHD stimulant drugs should be tested in the same way. (All the FDA-approved ADHD drugs are stimulants, except Strattera, which has a black box warning for an increased risk of suicidal thoughts in children.) The American Heart Association’s recommendation was based on the known effects of stimulants on the heart and the additional risk of sudden death or serious cardiovascular events these effects can produce in children with undiagnosed congenital heart defects. There is no controversy about this; the risks are known. Further, a doctor from the Children’s Hospital of Philadelphia reported that in 3 years of screening they found approximately 2% of children had previously unknown heart problems. Based on the number of children estimated to be taking ADHD medication, that would mean that from 50,000–80,000 children in the US who are taking ADHD stimulant drugs could currently be at an increased risk for cardiovascular problems or sudden death because of undiagnosed heart defects.

Despite the solid reasoning behind the American Heart Association’s recommendations, pharmaceutical industry-supported researchers have spoken out in opposition to the recommendation. They claim that no such precaution is needed because the rates for sudden death in ADHD drug takers is no higher than the rate of sudden death in the general population. These industry consultants ignore the undisputed facts that stimulants are dangerous to children with certain heart defects and that a significant number of those defects are undiagnosed. EKG screening is expected to save lives. See ADHD Drugs Information and Warnings for more information.

The American Heart Association action comes after years of inaction and relative inattention to the dangers of ADHD drugs from the FDA. ADHD drugs were headline news in 2006 when one FDA committee recommended a black box warning on all ADHD stimulant drugs for sudden death and serious cardiovascular side effects. The next month a second committee recommended stronger warnings, but not black box warnings for these and other dangers, such a hallucinations and psychotic symptoms and violence. A few months later the manufacturer of Dexedrine, GlaxoSmithKline, added a black box warning about sudden death to that drug.

All amphetamines already carry a black box warning for the dangers of amphetamine abuse. For all other ADHD stimulant drugs, the FDA directed the manufacturers in August 2006 to draft new medical guides. By February 21, 2007 those guides had not been completed and the FDA again requested revisions to include warnings about both cardiac dangers and adverse psychiatric events.

Meanwhile, Senator Charles E. Grassley of the Senate Finance Committee has continued an effort begun in 2007 to investigate and pass laws to stop conflicts of interest created by pharmaceutical companies and the researchers and organizations that promote their drugs and doctors who prescribe them. Senator Grassley has discovered many links between doctors who received large amounts of money from drug companies and the promotion of psychiatric drugs for children, including drugs for ADHD. Two Harvard researchers, Dr. Joseph Biederman and Timothy E. Wilens, have been actively involved in researching ADHD drugs and in promoting the off-label use of drugs to treat ADHD and other claimed psychiatric conditions in children. Off-label use means that doctors prescribe drugs for age groups or conditions not approved by the FDA. The lack of FDA approval means that the drugs have not been tested for safety or effectiveness with children.

Senator Grassley found that Dr. Biederman and Dr. Wilens had both falsely reported their income from pharmaceutical companies for the years 2000–2007. They claimed to have received a few hundred thousand each during that time, when they actually received at least $1.6 million each. Senator Grassley suspects the totals are even higher. These doctors are facing a review by a Harvard conflict committee, but the more important question is whether the millions of dollars they received influenced their active promotion of psychiatric drugs for children. Dr. Wilens, for example has been a spokesperson in opposition to the American Heart Association’s recommendation for more thorough exams, which might decrease industry profits. While it is legal for doctors to prescribe off label, it’s illegal for pharmaceutical companies to promote that use. When prominent researchers who receive millions from the pharmaceutical companies promote off-label use to doctors, this raises serious ethical and legal concerns, as well as concerns about the welfare of the children involved.

Check out the following articles for more information about ADHD drugs, filing an ADHD drug lawsuit and finding ADHD drug attorney.

• For more information about ADHD drugs side effects, see ADHD drugs Side Effects – Sudden Death, Heart Attacks & Strokes
  
• To find out more about the FDA warning, see ADHD drugs Side Effects and Risks
  
• For more information about ADHD drugs updates, see ADHD drugs Information and Warnings
  
• If you would like to learn more about ADHD drugs lawsuits, see ADHD drugs Lawsuits, Litigation & Lawyers
  
• To learn more about ADHD drug attorneys and how to find one, see Hiring an ADHD drugs Attorney and Lawyer
  

Suffered harm from an ADHD Drug? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.