FDA Issues Safety Communication Regarding Stimulant Medications Used in Children
LOS ANGELES, July 6, 2009 (GLOBE NEWSWIRE) -- CompuMed, Inc. (OTCBB:CMPD) (www.compumed.net) today launched a parental information program for its CardioGramKids(tm) Pediatric Screening Program. In tandem with pediatricians and other healthcare providers nationally, CompuMed is providing electrocardiogram (ECG) screening services to children and teenagers prior to prescribing or taking psychotropic medications. The U.S. Food and Drug Administration (FDA) issued a safety warning recently about stimulant medications in children which referenced a possible association between the use of stimulant medications for attention deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children. It referenced a study just published in the American Journal of Psychiatry. The FDA also warned parents that they should not stop a child's stimulant medication based on the study.
"Moms and Dads are not always aware of the potential side effects of certain drugs," said Maurizio Vecchione, CompuMed's CEO. "That's why we are launching this important parental education program. Children taking these medications are at risk of developing serious or life threatening cardiac conditions and should have ECG screenings prior to starting on these medications. We want parents to ask important questions about pre-screening their kids, which could save children's lives."
The American Heart Association and other leading groups have expressed concern regarding reports of sudden deaths of children and adolescents treated with psychotropic medications such as Ritalin(r), Adderall(r), Prozac(r), Paxil(r) and others. Medical journals have long stated concerns regarding the appropriateness of such therapy without taking suitable safeguards.
The FDA safety communication goes on to say, "That physicians follow the current prescribing information (labeling) for these products, which recommends that children, adolescents or adults who are being considered for treatment with ADHD drug products work with their health care professional(s) to develop a treatment plan that includes a careful health history for cardiovascular disease in the child and his or her family. This includes performing a physical exam with special focus on the cardiovascular system and consideration of further tests such as a screening electrocardiogram and echocardiogram, if the history or examination suggests underlying risk for or the presence of heart disease."
"We launched the CardioGramKids program six months ago in conjunction with a renowned university and others are signing up for our program expressing concerns about their pediatric patients and psychotropic drugs," said Mr. Vecchione.
