Concerta

This is the name of a prescription drug that is prescribed to children and adults.  Most people are, unfortunately, not fully informed by their psychiatrist, of the FDA warnings about Concerta.  Citizens Commission on Human Rights of Florida receives hotline calls, on a daily basis, and throughout these calls we do hear from individuals and parents who have concerns about Concerta side effects.

In the name of Informed Consent, which you can read more about here, this brief article will give you a few facts about Concerta.  You may find it helpful to read through and then if you have more questions please call our hotline at 800-782-2878.

In June of 2005, the Food and Drug Administration (FDA) determined that they had safety concerns with drugs that fall in the category of mehylphenidate (Ritalin, Adderall, Concerta, etc.)  The psychiatric adverse effects that were linked to these stimulant drugs are visual hallucinations, suicidal thoughts, psychotic behavior, aggression and violent behavior.  The FDA announced that it would be making changes to the labels of these drugs and would be examining other stimulant drug products that had been previously approved for the psychiatric dianosis of ADHD (Attention Deficit Hyperactivity Disorder).

Furthermore, in February of 2006, Federal science advisers voted to place the most serious type of warning labels for Conerta, Adderall, Ritalin and all other ADHD drugs.  The FDA voted in favor of adding a "Black Box" safety warning to these drugs. The FDA’s data suggested a link between ADHD drugs and an increased risk of sudden death and serious cardiovascular problems, including heart attacks.

In a current Wall Street Journal report, Johnson and Johnson, manufacturers of Concerta showed that the sales of this drug reached $1.3 billion in 2009.