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Misc. News : Non-food Things Last Updated: Apr 20, 2011 - 9:38:09 AM

FDA: Tell patients about risks of ADHD drugs
By Ben Wasserman -
Feb 22, 2007 - 9:57:24 AM

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The Food and Drug Administration on Wednesday announced its decision to require manufacturers of medications approved to treat Attention Deficit Hyperactivity Disorder (ADHD) to inform patients of possible adverse effects of using all types of ADHD drugs and approaches that can be used to minimize the risks.

The drugs of concern include Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin, Methylin, Ritalin, Ritalin SR, Ritalin LA, and Strattera, which are manufactured by a host of drug companies including Eli Lilly and Co, Novartis AG, Johnson & Johnson, and Shire plc.

The ADHD drug makers have been told to produce Patient Medication Guides to alert patients of possible risks of adverse cardiovascular and psychiatric symptoms and the precautions they may take to minimize these risks.

Patient Medication Guides are given to the patient, families and caregivers when an ADHD medicine is dispersed. The information is intended to prevent serious adverse side effects and remind patients of the possible risks associated with the ADHD drugs.

Patients being treated with ADHD drugs are advised to read the information in the FDA-pre-approved guides before taking the medication and talk to their doctors if they have any questions or concerns, the FDA says in a statement.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER).

"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."

ADHD, which is characterized by three major symptoms, inattention, hyperactivity and impulsivity, affects 3 to 7 per cent of schoolchildren and 4 percent of adults.   An estimated 2 million people in the U.S. suffer from this condition.

"People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem control," the FDA says.

The FDA's decision to provide patients with the information on ADHD drugs came after the agency reviewed reports of cases in which patients experienced adverse effects and concluded that patients who take ADHD drugs may be at slightly increased risk of cardiovascular adverse events or psychiatric adverse events.

According to the FDA, there have been reports of sudden death in patients on an ADHD drug with underlying serious heart problems or defects and reports of stroke and heart attack in adults with certain risk factors.

Taking ADHD medicines also increases risk by 1 per 1000 for drug-related psychiatric events such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

The FDA requires the drug makers to produce a patient medication guide for each ADHD medicine to give patients information on reported adverse events, who should not take the drug, common side-effects, drug ingredients,   and some basics about the medication.

Taking Adderall as an example, reported heart related adverse events associated with this ADHD drug include sudden death in patients who have heart problems or defects, stroke and heart attack in adults, increased blood pressure and heart rate.

Again taking Adderall as an example, reported mental or psychiatric problems associated with this ADHD medicine include new or worse behavior and thought problems, bipolar illness, aggressive behavior or hostility in all patients.   In children and teenagers, the problems also include new psychotic symptoms including hearing voices, believing things that are not true, and suspicious or new manic symptoms.

Taking Adderall may also slow growth in children and cause seizure, mainly in patients with a history of seizure, eyesight changes or blurred vision.   Common side effects with this ADHD medicine include headache, decreased appetite, stomach ache, nervousness, trouble sleeping dizziness, according to the patient medication guide draft indicated for the medicine.

Other ADHD may have the same or similar adverse effects as Adderall.   For the detailed guides for each ADHD drug, visit

The FDA recommends that patients who intend to use ADHD drugs talk to their doctors or healthcare professionals to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems.

In May 2006, the FDA already directed manufacturers of these ADHD products to revise product labeling to remind doctors of adverse cardiovascular and psychiatric events.

Critics complain that the FDA acts too slow.  In September 2006, Health Canada already warned patients of adverse cardiovascular events and psychiatric events associated with all types of ADHD drugs.

For more information, visit the following

Adverse effects of ADHD drugs ,
List of Patinet Medication Guide Drafts
*  ADHD drugs and Cardiovascular risk  
  General information on ADHD

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