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Concerta Review Shows Unexpected Psychiatric Reactions in Children

The FDA, after a Concerta review, plans to strengthen warnings about the possible psychiatric side effects of Concerta and similar drug treatments for ADHD. A routine FDA review of Concerta found that there have been dozens of reports of hallucinations, violence, thoughts of suicide and death. Yes, death. The FDA found 16 deaths from Concerta since the popular drug was first introduced five years ago. Some doctors have been quoted as saying that parents should not overreact to this report. But, if you are the parents of any one of those 16 children who died from taking the drug, you would absolutely argue that point.

The FDA website on Wednesday, June 29, 2005 listed the top 20 reported Concerta complaints found in its Concerta review. Below is a list of side effects currently not listed on the Concerta warning label:

  • Aggression

  • Abnormal behavior

  • Agitation

  • Hallucination

  • Anxiety

  • Depression

  • Suicide ideation (thoughts of suicide)

  • Completed suicide

  • Confusional state

  • Disorientation

  • Chest pain

Heart complications have also been found in addition to these unexpected psychiatric reactions in children.

Concerta, a once-daily form of methylphenidate (Ritalin), is now the most prescribed drug for ADHD. A subsequent review of other methylphenidate products found similar psychiatric complications. The FDA plans to conduct a review of Adderall and Strattera to see whether similar behavior is reported with these ADHD drug treatments. That review is expected to be complete early in 2006.

Adderall has already been linked to at least 20 deaths. In 2004 the FDA required that Shire Pharmaceutical Group, the makers of Adderall, provide doctors with warning about sudden cardiovascular death linked to Adderall. Canadian officials in February 2005 ordered Adderall off the market in Canada after reports of sudden deaths related to the drug.

Johnson & Johnson, the maker of Concerta, declined to comment on the FDA Concerta review.

It is natural for parents to question whether taking a powerful stimulant like Concerta is in their child's best interests. Stimulants like Concerta are worrisome for many reasons – predominately because of the potential for harmful Concerta side effects.

Most doctors believe the side effects of Concerta, and all ADHD medication, should be carefully weighed against the benefits before prescribing potentially harmful ADHD medication like Ritalin, Adderall, Concerta. Since Concerta does not cure ADHD, but only temporarily controls symptoms, a growing number of health professionals and parents alike now look to alternatives to ADHD medication to address the causes of Attention Deficit and hyperactivity. The more holistic and health-based physicians will often recommend supplements and lifestyle changes to diminish the symptoms of Attention Deficit Disorder and hyperactivity.

If you are concerned about the health effects of Concerta, or other ADHD medications, closely review Attend as a safe and effective alternative to drugs. There are healthful and effective ways of dealing with Attention Deficit Disorder, with seizure disorders and with depression that do not include the use of high-powered medications.

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