FDA requires ADHD drug makers to warn users about serious health risks

Friday, March 02, 2007 by: David Gutierrez, staff writer
Tags: ADHD drugs, ADHD, health news

(NewsTarget) The FDA has instructed manufacturers of drugs for Attention Deficit Hyperactivity Disorder (ADHD) to produce Patient Medication Guides warning patients about the risks of cardiovascular or psychiatric complications posed by those drugs. The guides also will advise patients about the precautions they should take while using the medications.

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What you need to know - Conventional View

• ADHD is claimed by the drug industry to be a persistent and chronic neurological disorder, the primary symptoms of which are hyperactivity, poor attention span and low impulse control. The FDA claims that between 3 and 7 percent of schoolchildren and 4 percent of adults suffer from ADHD.

• ADHD drugs, many of which are amphetamines, are known to have serious side effects in patients with underlying heart conditions and have led to fatal heart attacks and strokes in some cases. They also have been known to produce psychiatric disorders in those with no history of such conditions, including mania, paranoia or hearing voices.

• Prior to issuing the new rule, the FDA had been criticized for failing to notify the public about the risks of ADHD medications. As part of the new rules, the FDA advises doctors to carefully review patients' health and family histories before prescribing ADHD drugs.

• The rules affect 15 products, including varieties of Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin and Strattera. The affected drug manufacturers include Eli Lilly and Co, Novartis AG, Johnson & Johnson and Shire Pharmaceuticals Group plc.

• Quote: "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns." - Dr Steven Galson, director of the Center for Drug Evaluation and Research

What you need to know - Alternative View

Statements and opinions by Mike Adams

• ADHD is an utterly fictitious disease that was invented by drug companies and the psychiatric industry to generate profits by drugging children. This so-called "disease" has no biological test, no physiological evidence and its diagnosis is based entirely on the casual opinion of a psychiatrist or doctor, most of which have been heavily influenced by drug company lobbying efforts.

• The FDA continues to ignore the real dangers of ADHD drugs and seems to be intentionally dragging its feet on admitting to any safety problems whatsoever. This latest warning is only due to a reluctant FDA being forced to admit to a few safety issues for a class of dangerous drugs that should be banned entirely.

• Selling street drugs to schoolchildren is illegal, but when those same chemicals are packaged as pharmaceuticals, they are not only legal, they're actually promoted by doctors and school administrators.

• Public schools are financially rewarded for diagnosing their students with ADHD. For every student in their school with an ADHD diagnosis, the school receives extra funds from the government.

Resources you need to know

• Visit the Citizens Commission on Human Rights: www.CCHR.org

Bottom line

• Drug manufacturers now are required to warn patients about the risks associated with drugs used to treat Attention Deficit Hyperactivity Disorder.