ADHD Drugs Tied to ER Visits
CDC Doctors Estimate More Than 3,000 Emergency Room Trips From ADHD Drugs in 2004
Drug Company Responds continued...
"Regarding emergency room visits due to overdoses and misuse of ADHD medications reported by the CDC, when used inappropriately all medications have unpredictable effects. ADHD medications should only be used as indicated under the care of a qualified physician," the statement continues.
"Ritalin, approved by the FDA in December 1955, has a long record as a safe and effective medication for the symptoms of ADHD. For more than 50 years it has helped patients and their families lead more productive, healthy lives," states Novartis.
Estimates Too Low?
Cohen and colleagues note that ER estimates may be too low because some cases may not have been recorded in the database or may be difficult to diagnose in an emergency department.
"Nevertheless, we found that visits to an emergency department for adverse drug events due to stimulant medications are not uncommon," they write.
Cohen's team adds that doctors "should recognize that unintentional overdoses of stimulant medications are an important cause of injury to patients, and they should investigate cardiovascular symptoms of potential concern among patients taking stimulant medications." Doctors should also report serious adverse events to the FDA, note Cohen and colleagues.
Debate Over Possible 'Black Box' Warning
On Feb. 9, an FDA advisory panel recommended that stimulants prescribed for ADHD get a "black box" warning about a potential risk of heart attack, stroke, and sudden death.
That recommendation touched off a flurry of doctors' letters published in The New England Journal of Medicine.
In a joint letter to the journal, Thomas Anders, MD, of the American Academy of Child and Adolescent Psychiatry and Steven Sharfstein, MD, of the American Psychiatric Association write that they are "concerned that such a warning will discourage patients and their families from using effective treatment.
"Untreated ADHD is associated with an elevated risk of substance abuse, academic failure, and motor vehicle accidents and an increased rate of psychiatric disorders," write Anders and Sharfstein.
Novartis, in its statement emailed to WebMD, commented on the journal letters: "Novartis fully supports the FDA's efforts to ensure that safety information in product labels for all ADHD medications is as clear as possible."