More Risks Added to ADHD Drug Label Warnings
Drug manufacturers of stimulant medications used to treat attention deficit hyperactivity disorder are following the Food and Drug Administration’s request to add stronger warning labels notifying consumers of the serious risks linked to the drugs.
GlaxoSmithKline PLC have become the most recent company to add the new safety labels to their stimulant drug Dexedrine. The new warning will highlight the possible risks of cardiovascular problems and psychiatric events that have been associated with the use of some ADHD medications.
Similar warnings were added to the labels for other drugs in the same category including Shire PLC’s Adderall and Johnson & Johnson’s Concerta.
According to a spokeswoman for the FDA, the agency asked drug manufacturers to strengthen their warnings to address the serious risks of cardiovascular and psychiatric effects. However, they do not believe the risks “justify a black box,” the strongest possible label warning.
The new drug labels on ADHD stimulant medications warn that there are some reports of sudden death in children using the drugs who have cardiac abnormalities or other severe heart complications.
Furthermore, the labels states that heart attacks, strokes, and sudden death have also been reported in some adults taking ADHD drugs. Other serious side effects listed on the new drug labels say “psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history” of these problems “can be caused by stimulants at usual doses.”
According to the drug label, all patients should have a medical background check for signs of heart conditions that could pose severe risks when taking ADHD drugs.