In NJ, A Fight Over Black Box Warnings
2 CommentsBy Ed Silverman // June 20th, 2007 // 3:18 pm
A battle is brewing in the nation’s medicine chest, where the local arm of the American Academy of Child & Adolescent Psychiatry objects to a bill that would require docs and other prescribers to obtain informed consent from parents for psychotropic meds with Black Box warnings. Apparently, this is the first state in which such a bill is being proposed.
In a June 11 letter to a state assemblyman, the group’s president, Hayley Cohen, writes the bill “has the potential to adversely impact the treatment of children with psychiatric illness, for example, childhood and adolescent depression.” Ever since the FDA mandated the warnings two years ago, psychiatrists cite studies indicating usage has dropped.
The bill was introduced by state assemblyman Patrick Diegnan at the urging of two very vocal NJ residents who call themselves parental advocates; each had a child attempt suicide after taking an antidepressant and became active in pushing the FDA to mandate warnings and medication guides. And they predict parents in other states will push for similar legislation if the NJ bill passes. “It will become a domino effect,” says Lisa Van Syckel.
Cohen didn’t return phone calls to chat about the bill. The American Academy of Child & Adolescent Psychiatry has opposed Black Box warnings on antidepressants since the controversy erupted three years ago. A recent JAMA study fueled the debate, although the FDA went ahead and updated the warnings anyway.
Meanwhile, the same assemblyman has introduced a separate bill that requires school districts to inform the parent or guardian of a student who’s been recommended to use certain meds of the possible side effects and potential negative consequences. Like the other bill, this would also pertain to antidepressants, antipsychotics and ADHD meds.
Lisa Van Syckel
Ed,
Dont feel bad,Dr. Cohen never returned my phone call either…
The Bias and Vested interest of those proclaiming that the Black Box Warning is the cause of the increase risk of suicide rates between2003 and 2004.Almost all of the “Scientists speaking out about the black box and its relationship to rising suicide rates have a vested interest(Including an interest in defending their own actions of promoting the use of the drugs for children and teens despite an abscence of efficacy data)and most have pharmaceutical industry ties
The FDA’s analasys which found that antidepressants cause suicide in children and teens was not announced until Sept. 2004 PDAC Meeting.The Fda did not ask the manufacturers of antidepressants to place a Black Box in their labels until Oct 2004.
The Black Box warnings didnt go into effect until January/February 2005,WELL BEYOND THE CDC ANALASYS TIME PERIOD!!!!
In 2003,US Physicians wrote 15 MILLION Prescriptions for patients under 18 According to FDA Data.IN THE FIRST 6 MONTHS OF 2004,ANTIDEPRESSANTS PRESCRIPTIONS FOR CHILDREN INCREASED BY 8%,DESPITE THE NEW DRUG LABELING…….
The current trend in suicides for children and teens could be the result of abrupt withdrawal or the METEORIC RISE IN PEDIATRIC PRESCRIPTIONS OF ATYPICAL ANTIPSYCHOTICS,SUCH AS ZYPREXA AND RISPERDAL,WHICH GREW 117% IN TEEN GIRLS AND 71% IN BOYS(ACCORDING TO MEDCO HEALTH SOLUTIONS.THE SUICIDE RATES ARE EVEN HIGHER IN PATIENTS TAKING ANTIPSYCHOTICS….
Laurie
One has to question their motivation when the incidence of suicidaility is well documented. When did it become ethical to keep patients in the dark on possible drug reactions?