Massachusetts Child Psychiatry Access Project: MCPAP

FDA Mandates Suicidality Warning on All Epileptic Drugs

The FDA announced on December 16, 2008 that it will require the manufacturers of antiepileptic drugs to add a warning that the use of antiepileptic drugs increases suicide ideation.  Antiepileptic drugs are used to treat epilepsy, psychiatric disorders, migraine headaches, and other conditions.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, " said Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research."

Click here to link to the FDA press release.

Click here to link to the Associated Press article on the FDA mandate regarding anti-epileptic medication.

Click here for the February 12, 2008 MCPAP post on this issue.

Cognitive Behavioral Therapy plus Sertraline (Zoloft) Helps Kids with Anxiety

According to a recent study published in the New England Journal of Medicine, both cognitive behavioral therapy (CBT) and sertraline (Zoloft) reduce the severity of anxiety in children with anxiety disorders. However, a combination of the two therapies has a superior response.

Click here to view the New England Journal of Medicine article.

Click here to view an MSNBC article summarizing the NEJM findings.

FDA's New Drug Safety Resources Web Page

The FDA has announced a new web page that provides a wide variety of safety information about prescription drugs.  The web page includes information about drug labeling, risk evaluation and mitigation strategies, studies and clinical trials, safety information, warnings and recalls, and more.  It also includes a list of drugs for whick medication guides are available.   This web page is a good resource for information on prescription drugs including those drugs used to treat behavioral health issues.

Click here to visit the new "Postmarket Drug Safety Information for Patients and Providers" web page.

New AHA Recommendations regarding Stimulant Medications

The American Heart Association has published a scientific statement with new recommendations regarding the assessment of cardiovascular risk in children prior to being treated with stimulant medication.

Statement from AHA

Specifically, the statement recommends that children diagnosed with ADHD get an EKG to rule out heart abnormalities before starting stimulant medication and that children currently taking stimulant medications should get an EKG if they haven't already done so. 

This statement was released yesterday and there is some controversy about the recommendation.  Notably, children on stimulant medication are not considered to be at higher risk of sudden death than other children, and pre-screening children with EKG may be a barrier to treatment for some children.  Previous clinical practice guidelines such as the AACAP Practice Parameter has not recommended routine EKG's for children with ADHD.  In meantime, primary care clinicians should certainly make themselves aware of these AHA recommendations and consider making appropriate adjustments in their clinical practices.

Click below to download the statement that the American Academy of Pediatrics made on their list serve in response to the AHA recommendation.

Download aap_response_to_aha_recfor_cardiac_screen_of_ped_adhd_patients.doc

As this issue is discussed further in the medical and scientific community, we will look forward to providing updated information. 

FDA Issues Warning of Increased Suicide Ideation for Patients Who Take Antiepileptic Drugs

According to a recent FDA study, taking antiepileptic drugs doubles the risk for suicide ideation as compared to placebo,  Antiepileptic drugs are prescribed as treatment for epilepsy, bipolar illness, and mood problems.

The FDA advised health care providers to notify patients, their families, and caregivers of the potential increase in suicidal thoughts in patients who take antiepileptic medications.  These patients should be monitored for changes in behavior and suicidality.

Click the below link to view the FDA press release:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

CDC Reports Rise in Kids’ Suicides: Data Coincides with FDA Black Box Warning

The Centers for Disease Control recently released data that shows an 18% increase in the suicide rate for children under 20 from 2003 to 2004. This increase coincides with the FDA black box warning cautioning that antidepressants could cause suicidal behavior in children. As antidepressant prescriptions for children decreased because of the black box warning, suicide rates actually rose. The CDC will issue a more comprehensive report within the next couple of months.

 

Please see the below entries on our website entitled Treating Pediatric Depression in Primary Care: Coping with the Patients’ Blue Mood and the FDA’s Black Box and Lost in the Black Box: Juvenile Depression, Suicide, and the FDA’s Black Box Warning for more information on how to treat depression in children in light of the FDA’s black box warning.

Treatment of ADHD with Stimulant Medications: Response to Nissen Perspective in The New England Journal of Medicine

In a commentary soon to be published in the Journal of American Academy of Child and Adolescent Psychiatry, Drs. Biederman, Spencer, Wilens, Prince, and Faraone respond to cardiologist Dr. Steven Nissen's comments about ADHD and its treatment with stimulant medications. Biederman et al respond to Nissen's claims that ADHD is over diagnosed and over treated.  Beiderman et al clarify that stimulants used to treat ADHD in children do not pose undue cardiatric risks for patients except for those who may have underlying structural heart defects.  Biederman et al provide information regarding risks of non-treatment of ADHD.  The risks of non-treatment include motor vehicle accidents, smoking, and substance abuse.  Biederman et al believe that the risks of non-treatment should be weighed seriously when considering management of this disorder. An extensive review of this issue will appear in the October 2006 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

Biederman et al's comments reflect similar sentiments to those expressed by Dr. Thomas Anders from the American Academy of Child and Adolescent Psychiatry, Washington, DC and Dr. Steven Sharfstein from the American Psychiatric Association, Arlington, VA.  Anders and Sharfstein expressed their remarks regarding Nissen's April 6th New England Journal of Medicine article in their May 25th correspondence to the editor of the New England Journal of Medicine.  Click here for the link to  Anders and Sharfstein's comments.

In the April 6th article in the New England Journal of Medicine entitled ADHD Drugs and Cardiovascular Risk, cardiologist Steven A. Nissen discusses what he believes to be the cardiovascular risks of stimulant use for ADHD patients. Although Nissen does believe that stimulants have proven to be an effective treatment for ADHD, he recommends a black-box warning.  His article does not consider the risks of non-treatment.  Click here for the link to the Nissen article.

AACAP Offers Free Online CME Program on Psychopharmacological Treatment and FDA Safety

The American Academy of Child and Adolescent Psychiatry (AACAP) has announced a new online CME program called "Evidence-Based Psychopharmacological Treatments for Youth in a Time of Regulatory Uncertainty".  This online program based on the AACAP January 27-28 2006 conference is free for viewing.  ( For physicians who want CME credit, the cost is $120.)

This program is designed for child and adolescent psychiatrists, pediatricians, family practice physicians, and other healthcare professionals.  Sessions include information about SSRIs; second generation antipsychotic medicine, weight gain, and diabetes; psychopharmacological treatments of maladaptive aggression; psychopharmacological treatments for ADHD, Bipolar, Autism, Anxiety, Tourette's Disorder, and Obsessive Compulsive Disorder (OCD): and endocrine complications of psychopharmacological agents.

Click here for a direct link to the program.

Treating Pediatric Depression in Primary Care: Coping with the Patients' Blue Mood and the FDA's Black Box

What does the primary care physician do about treating pediatric depression now that the FDA has issued a black box warning for antidepressants?  May 2006 article entitled Treating Depression in Primary Care written by Nancy Rappaport, MD, Jeff Bostic, MD (MCPAP psychiatrist-MGH) , Jefferson Prince, MD (MCPAP psychiatrist- North Shore Medical Center), and Michael Jellinek, MD describes characteristics and treatment of pediatric depression.  Treatment may include Cognitive Behavioral Therapy (CBT) and/or medication.  A table of various CBT techniques which a pediatrician may incorporate in treating those with depression is included.  The article explains the monitoring of antidepressants in pediatric patients in light of the recent FDA black box warnings.

Lost in the Black Box: Juvenile Depression, Suicide, and the FDA's Black Box Warning

This November 2005 Journal of Pediatrics article entitled  Lost in the Black Box written by Harvard Medical School psychiatrists Dr. Nancy Rappaport, Dr. Jefferson Prince ( MCPAP psychiatrist- North Shore Medical Center) and Dr. Jeff Bostic ( MCPAP psychiatrist-MGH)  explores the epidemiology of depression and suicide in children. Lost in the Black Box looks at the factors surrounding the recent FDA's black box warning.  The article describes the limitations constrained by the FDA in evaluating suicide data in children treated with SSRIs.  The article also explores conflicting research regarding the use of SSRIs and suicides. The researchers conclude that black box warning illuminates the fact that mental health problems in children and adolescents warrant careful attantion by clinicians.