WARNING LABELS FOR RITALIN AND CONCERTA TO BE STRENGTHENED BY FDA IN RESPONSE TO REPORTS OF ADVERSE PSYCHIATRIC AND CARDIOVASCULAR SIDE-EFFECTS

The FDA has had every reason to monitor adverse event reports very carefully with respect to all of the drugs used in the treatment of ADHD. Of course, an adverse event report neither identifies a side-effect nor confirms one?s existence. It may truly be something to watch or it may simply be an occurrence unrelated to the drug being taken.

Even when a link to a particular prescription drug is not proven, the FDA and the manufacturer often mention these events on the label. Recent high profile drug withdrawals, pressure from consumer advocacy groups and lawmakers, and a move toward greater disclosure of adverse information about prescription drugs have prompted the FDA to be more proactive in terms of identifying and following potential safety problems.

In addition to the possible psychiatric problems associated with the drugs, the FDA is also concerned over reports of cardiovascular problems including hypertension, arrhythmias, chest pain, and tachycardia in Concerta users. As a result, further steps may be taken to investigate these issues by way of data base studies or new safety trials.