The FDA has approved a new, stronger warning for Dexedrine, now viewed as a dangerous drug, and some of the other ADHD drugs based on studies by two different FDA advisory committees which considered the safety of ADHD drugs in February and March 2006.
The primary distinctions between the recommendations made by these two advisory committees were, to start, the extent of cardiovascular risks associated with Adderall, Concerta, Ritalin, Dexedrine, as well as some other ADHD drugs and, then, whether those risks warranted the addition of a "black-box" warning on the package insert for these controversial stimulants.
In February 2005 Health Canada pulled Adderall XR from the market based on reports that 20 people taking the drug died. Health Canada returned Adderall to the market in August 2005, and in May 2006 issued a safety alert warning against the use of ADHD drugs by people with high blood pressure, heart disease, and certain other medical problems.
The Food and Drug Administration says the dangerous drugs of concern, which include Dexedrine (Glaxo) and Ritalin (Novartis), are stimulants that can raise blood pressure, and must also include warnings about the risk of behavioral problems such as aggression and mania.
Dexedrine will also include warnings about the risk of sudden death, hypertension and other concerns associated with stimulant treatment in children and adolescents who have heart problems.