NYSOMH Issues Alerts, Guidelines re Antidepressant Use in Children, Teens

NYSOMH Issues Alerts, Guidelines re Antidepressant Use in Children, Teens

Wed, 29 Dec 2004

The NYS Office of Mental Health has issued letters and an advisory to state mental health providers “explaining” FDA’s warning and the use of antidepressants in children. As you will note, OMH downplays the meaning of the “Black Box” warning and the potential hazardes of the drugs:

“Suicidal thoughts are often a symptom of depression. From the recent review of the research, it is difficult to say precisely whether suicidal thoughts and behaviors in depressed individuals are due to the illness itself or the antidepressant medication. It can be either or both of these factors.”

OMH’s advisory essentially reaffirms its adherance to the drug industry financed protocol–as outlined in the Texas Medication Algorithm Project (TMAP) recommendations for the treatment of depression in children. OMH officials remind NYS providers of mental health services that although cognitive behavioral therapy and interpersonal psychotherapy were shown tobe effective, these non-drug therapies are unavailable. Therefore, the OMH conclusion is that SSRIs remain the treatment of choice for childrenŠ.OMH clearly has no plans to shift funds toward non-drug therapies.

II. Summary of Key Issues and Analysis of Key Data:

“Pediatric depression is a real illness and treatment is effective. In the United States, depression is responsible for over 500,000 suicide attempts by children and adolescents each year. Untreated depression carries significant rates of impairment and risk.”

“Based on an evaluation of the current research evidence, first line treatments for moderate to severe depression in adolescents (ages 13-18 years) include the antidepressant fluoxetine, cognitive behavioral therapy (CBT), and the combination of fluoxetine and CBT. Interpersonal psychotherapy (IPT) has also been shown to be effective.

Note: In view of the limited availability of CBT and IPT in some clinical settings, other forms of psychotherapy may be considered. However, in spite of their widespread use in clinical practice, there is very limited research evidence that these other forms of psychotherapy are effective in depressed adolescents.”

And then there is an implied threat to state providers….and parents…

“The risks associated with “non-treatment” must also be considered. Failure or refusal to treat significant psychiatric and behavioral problems in children and adolescents (including reluctance or failure to use medication) can also carry risk.”

I hate to be the one to deflect our sense of accomplishement…but:

2005 may prove to be decisive: either we can mount an effective campaign to counteract this well organized propaganda, or millions of children will be subjected to psychotropic drugs. The President’s New Freedom Commission for Mental Health recommendations are clearly and evidently promoting the TMAP model which was developed and financed by psychotropic drug manufacturers.

The TMAP project was sponsored by virtually every major antidepression drug manufacturer.

See Allen Jones report: http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf

I’ve also received the following from a thoughtful professional ally:

Vera, I spent some time yesterday looking, via the Web, at the New Freedom Commission, its drugging plans, and its allies, affiliates and fellow travelers. The omens are not good. The campaign is much better organized, more extravagantly funded, and planned with much more sophistication than past boondoggles, for example, the so-called Violence Initiative of a few years ago. I believe its organizers, the pharmaceutical manufacturers, have anticipated the resistance they will encounter and have lined up an array of commercial/bureaucratic/organizational forces that will steamroller the types of opposition that they (and I) have seen before and expect again.

Effective opposition, I suspect, will require organizational efforts that have few precedents, if any.

Best wishes for 2005 —

Vera

Contact: Vera Hassner Sharav
212-595-8974

Subj: NYSOMH Issues Alerts, Guidelines re Antidepressant Use in Children, Teens
Date: 12/28/2004 7:51:05 AM Eastern Standard Time
From: enews – nyaprs.org

NYS Office of Mental Health Letter to Facilities and Programs Concerning Antidepressant Use in Children and Adolescents

TO: State operated facilities/programs
FROM: James MacIntyre, M.D, Interim Chief Medical Officer
David J. Woodlock, Deputy Commissioner and Director,
Division of Children and Family Services SUBJECT: RE: Antidepressant Use in Children and Adolescents
DATE: December, 2004

On Friday, October 15, 2004, the U. S. Food and Drug Administration (FDA) announced new warnings and precautions to strengthen safeguards for children and adolescents treated with antidepressant medications. In response, the New York State Office of Mental Health has prepared a Clinical Advisory and Issue Analysis (attached) to assist practitioners and clinicians in understanding the complex issues surrounding the FDA’s increased warnings (i.e. “black box”) on antidepressant use with children and adolescents.

The attached clinical advisory includes principles of practice and strategies for patient management, however it is not intended to define the standard of care, nor is it inclusive of all methods of care. The ultimate judgment regarding care of a particular patient must be made by the clinician in light of all the circumstances presented by the patient and his/her family and the diagnostic and treatment resources available.

OMH has also developed the attached letter that could be used with parents/families to explain the FDA warnings about antidepressants in children and adolescents.

We hope this information is helpful and assists you in continuing to provide high quality care and treatment to children and adolescents with serious emotional disturbances.

Sincerely,

James MacIntyre, M.D Interim Chief Medical Officer

David J. Woodlock Deputy Commissioner and Director,
Division of Children and Family Services

Cc: Sharon E. Carpinello, R.N., Ph.D., Commissioner
Barbara L. Cohn, Executive Deputy Commissioner
————————

NYS Office of Mental Health Letter to Parents Concerning the FDA Warning About Using Antidepressants in Children and Adolescents

TO: Parent/Guardian
FROM: James MacIntyre, M.D, Interim Chief Medical Officer
David J. Woodlock, Deputy Commissioner and Director,
Division of Children and Family Services SUBJECT: RE: FDA Warning About Using Antidepressants in Children and Adolescents DATE: December, 2004

Dear Parent/Guardian,

You may have heard or read news reports on prescribing antidepressant medications for children and adolescents. The news reports were about the recent meetings and decision by the Food and Drug Administration (FDA). The FDA reviewed all the studies that used newer antidepressant medications to treat depression and anxiety disorders in children and adolescents. The FDA carefully examined the effectiveness of antidepressant medications, as well as concerns about increased risk of suicidal behavior (such as a suicide attempt or suicidal thoughts) in children and adolescents who were taking these medications.

This letter should explain some of the FDA information and answer some of the questions that you may have about antidepressant medications in children and adolescents.

What did the Food and Drug Administration (FDA) Find and Decide?

After two days of hearings and reviewing all the studies, the FDA concluded that there is some increased risk of suicidal behavior (such as a suicide attempt or suicidal thoughts) for some children or adolescents taking antidepressants. The studies showed that 3-4 out of 100 children or adolescents with depression who took an antidepressant medication had some type of suicidal behavior and that 1-2 out of 100 children and adolescents taking a placebo (inactive pill) had some type of suicidal behavior. Therefore, there was almost a 2-fold increase in suicidal behavior in youth taking an antidepressant medication to treat their depression. There were NO deaths from suicide in any of these studies, which included over 4,000 children and adolescents. For children and adolescents with an anxiety disorder, there was no difference in risk of suicidal behavior between those being treated for their anxiety disorder with an antidepressant compared to those taking a placebo (inactive pill).

As a result of the hearings and their review, the FDA now requires the strictest warning label be placed on all antidepressants regarding their use with children and adolescents. This type of warning label is called a “black box”. Whenever a physician prescribes any one of the antidepressant medications, he/she now has to clearly warn patients and their families about the increased risk of suicidal thoughts and behaviors in youth taking these medications.

How does the FDA decision and warning affect your child?

Suicidal thoughts are often a symptom of depression. From the recent review of the research, it is difficult to say precisely whether suicidal thoughts and behaviors in depressed individuals are due to the illness itself or the antidepressant medication. It can be either or both of these factors. As the FDA’s warning states, in some children and adolescents, antidepressant medications may increase these types of thoughts.

If your child is already being treated with one of the antidepressant medications and is doing well, then your child should continue with that treatment. If you have questions, doubts or concerns, you should talk with your child’s physician.

If your child has recently started one of these medications or is about to start, then you and your child’s physician will need to closely monitor him/her for any changes in behavior. In most cases, the increased risk of suicidal behavior occurs during the first 4-6 weeks of treatment.

If you are considering starting your child on one of the antidepressant medications, then you should have a full discussion with your child’s physician of the possible benefits as well as the possible risks (including increased suicidal behavior).

What should you do as a parent?

Be clear and honest when talking with your child about the possible risks and benefits of taking an antidepressant medication.

Talk to your child or adolescent about whether they are having any suicidal thoughts, and let them know they should come to you immediately if they start having suicidal thoughts or any other troubling symptoms while they are taking antidepressant medication.

Working with your child and your child’s physician, you should develop a “safety/crisis plan” for your child. This can include identifying an adult your child can call if he/she is thinking about suicide.

You and your child’s physician should closely monitor your child – especially during the first months of treatment. Any child or adolescent starting an antidepressant medication should be followed weekly (in person or by telephone) for the first month, every other week (preferably in person) for the second month, and at least once a month (in person) thereafter by the treating physician to check for the severity of depressive symptoms, suicidal behavior and any other problems.

It is important that you do not suddenly stop or change the dose of your child’s antidepressant medication without first talking to your child’s physician.

What should you look for when monitoring your child on an antidepressant medication?

Watch for any behaviors or symptoms/complaints that appear in your child for the first time, seem worse, or worry you or your child.

Watch for any suicidal symptoms in your child – such as ideas of hurting oneself, thoughts or threats of committing suicide or any self-harming behaviors or suicide attempts.

Watch for signs of new or increased depressed mood or anxiety (including nervousness, panic attacks) in your child.

Also watch for any of the following symptoms that may appear in your child: insomnia, irritability, hostility, aggressiveness, and impulsivity.

If any of these behaviors or symptoms appear, you should immediately contact your child’s physician for guidance.

REMEMBER: Only you, your child and your physician can look at all the specific information and make an informed and appropriate decision about using an antidepressant medication.

If you have any questions about the information in this letter, we recommend you speak with your child’s physician. We hope that this information has been helpful.

Sincerely,

James MacIntyre, M.D Interim Chief Medical Officer
David J. Woodlock Deputy Commissioner and Director, Division of Children and Family Services

Cc: Sharon E. Carpinello, R.N., Ph.D., Commissioner
Barbara L. Cohn, Executive Deputy Commissioner
————————

Clinical Advisory and Issue Analysis Regarding Antidepressant Use in Children and Adolescents
Date of Issue: December 2004

In view of the complex issues, controversy and recent increased warnings and precautions announced by the U. S. Food and Drug Administration (FDA) regarding the use of antidepressants in children and adolescents, OMH has prepared this clinical advisory and issue analysis to assist practitioners and clinicians in psychiatric decision making.

This clinical advisory includes principles of practice and strategies for patient management, however, it is not intended to define the standard of care, nor is it inclusive of all methods of care. This advisory is based on an evaluation of currently available scientific literature and recent information from the FDA. The ultimate judgment regarding care of a particular patient must be made by the clinician in light of all the circumstances presented by the patient and his/her family and the diagnostic and treatment resources available.

I. Background:

Beginning in June 2003 there has been increased concern about both the safety and effectiveness of 9 antidepressants in children and adolescents.

The antidepressants include 6 serotonin reuptake inhibitors (SSRI) – Citalopram (Celexa); Escitalopram (Lexapro); Fluoxetine (Prozac); Fluvoxamine (Luvox); Paroxetine (Paxil); Sertraline (Zoloft); and 3 others – Bupropion (Wellbutrin); Mirtazapine (Remeron);Venlafaxine (Effexor)

Since the Fall of 2003, the FDA has conducted a series of hearings regarding the safety and efficacy of antidepressants in children and adolescents. As part of this process, the data from all studies (N=24 placebo-controlled) involving the 9 antidepressant medications in children and adolescents (both published and unpublished) have been carefully reviewed and the data re-analyzed.

In March 2004 the FDA required pharmaceutical companies to significantly strengthen the warning language with antidepressant medications to include monitoring for signs of suicidal thinking or behavior during treatment.

In September 2004, after reviewing all the studies and as a result of the hearings the FDA’s Advisory Committee recommended that the FDA require pharmaceutical companies to create a “black box warning” on all antidepressants about the medication-induced risk of increased suicidal thinking and behavior in children and adolescents. They also recommended that a patient medication guide be provided to the patient/family with each prescription. The “black box warning” is the FDA’s strongest indication of risk with a particular medication.

On October 15, 2004 the FDA announced that it would be requiring a “black box warning” on all antidepressants regarding their use in children and adolescents. This stronger warning applies to all antidepressants (the 9 listed above plus all tricyclic and MAO inhibitor antidepressants). Based on their analysis of the data, the FDA decided to strengthen safeguards for children and adolescents treated with antidepressants in view of the medication-induced risk of increased suicidal thinking or behavior. According to the FDA, the “black box warning” will also contain specific recommendations for monitoring of a patient as well as information to be provided to the patient and family. At this time the specific FDA language for the warning has not yet been made available.

II. Summary of Key Issues and Analysis of Key Data:

Pediatric depression is a real illness and treatment is effective. In the United States, depression is responsible for over 500,000 suicide attempts by children and adolescents each year. Untreated depression carries significant rates of impairment and risk.

Currently, fluoxetine (Prozac) is the only antidepressant approved (i.e. “labeled”) by the FDA for use in pediatric depression (i.e. children and adolescents). The prescribing of all other antidepressants in children and adolescents for any use is categorized as “off-label” use.

To date, only fluoxetine (Prozac) has been shown to be clinically effective with depressed adolescents in two (2) carefully designed research studies.

From the FDA’s review of the 24 SSRI antidepressant studies involving 4,400 children and adolescents, they concluded that all the SSRI (including fluoxetine) and other newer antidepressants can increase the risk of suicide-related thoughts and/or self-harming behavior in some children and adolescents (78 of 4,400 patients). The FDA analysis identified the average medication-induced risk to be 4% compared to 2% for a placebo. This means that statistically, 4 children and adolescents out of 100 patients treated might show increased suicidality due to the antidepressant medication. The medication-induced risk is greater when starting or adjusting the dose of these antidepressant medications.

In the 24 studies reviewed involving children and adolescents taking SSRI antidepressant medications, there were no deaths. Also, none of the patients with increased suicidal ideation or behavior went on to commit suicide.u New research in the treatment of adolescent depression (i.e. Treatment for Adolescents with Depression Study – TADS) demonstrates that the combination of therapy (cognitive behavioral therapy) and antidepressant medication (fluoxetine) results in successful treatment (71% of depressed adolescent patients responded positively to the combination treatment compared to 35% of patients on placebo).

In spite of the “black box warning”, the FDA has not taken a position that SSRI and other new antidepressants are contraindicated in children and adolescents. Therefore, these medications (9 listed above) can continue to be prescribed for children and adolescents if rational prescribing principles are followed.

III. Rational Prescribing Principles for Any Psychiatric Medication:

OMH recommends the following principles whenever any psychiatric medication is being prescribed for a child or adolescent:

Psychiatric medication(s) should not be prescribed until a thorough psychiatric assessment is conducted by a qualified professional.

Psychiatric medication(s) should rarely be used as the sole treatment modality or intervention for a child or adolescent with a mental disorder.

Selection of a specific psychiatric medication for a particular psychiatric or behavioral problem should be based on support from the scientific literature and evidence base (when it exists).

Each decision to use a psychiatric medication must be carefully individualized by the prescribing physician. The decision should be based on a discussion between the physician, parents and patient of the potential benefits and the potential risks (including side-effects) of using a particular medication as well as alternative treatments.

The risks associated with “non-treatment” must also be considered. Failure or refusal to treat significant psychiatric and behavioral problems in children and adolescents (including reluctance or failure to use medication) can also carry risk.

Prescribing physicians must work with the parents/guardians to carefully assess for response (or non-response) to treatment, and emergence of side-effects during the course of treatment with a medication. Regular communication between the physician and parents/guardians is essential. Symptoms and side-effects are best tracked using standardized rating scales or other quantifiable measures.

A decision to stop or change the dose of any psychiatric medication must involve a discussion between the psychiatrist or physician, patient and parents/guardians.

IV. Specific Recommendations re: SSRI and Other New Antidepressants and Depression:

OMH has the following specific recommendations regarding the use of the 9 newer (6 SSRI and 3 others) antidepressants in depressed children and adolescents:

Based on an evaluation of the current research evidence, first line treatments for moderate to severe depression in adolescents (ages 13-18 years) include the antidepressant fluoxetine, cognitive behavioral therapy (CBT), and the combination of fluoxetine and CBT. Interpersonal psychotherapy (IPT) has also been shown to be effective.

Note: In view of the limited availability of CBT and IPT in some clinical settings, other forms of psychotherapy may be considered. However, in spite of their widespread use in clinical practice, there is very limited research evidence that these other forms of psychotherapy are effective in depressed adolescents.

SSRI antidepressants can be prescribed for moderate to severe depression in adolescents (ages 13-18 years) since there is some research evidence of their clinical effectiveness.

Current evidence for the safety and efficacy of the SSRI antidepressants in children (under 13 years of age) is much weaker. Therefore, a clinical decision to use SSRI antidepressants for an individual child must be based on a careful evaluation of potential risk versus potential benefit.

Whenever antidepressants are prescribed, parents, families and patients should receive complete written information about the specific medication. The FDA will be defining the content of this information. The written information should include a list of suicidal symptoms, such as increased suicidal ideas or thoughts and self-harming behaviors. Parents/guardians should be advised to immediately contact the prescribing physician if suicidal ideation or self-harming behavior occurs.

For the first 4 weeks of treatment with SSRI antidepressants, patients should be followed weekly (in-person or by telephone) to monitor severity of depression, response to treatment and possible emergence of side-effects (including suicidal ideation, self-harming behavior). During the monitoring contacts, the physician should ask the patient and family specifically about any new or increased suicidal ideation or occurrence of self-harming behavior.

For weeks 5-8 of treatment (2nd month) of treatment with SSRI antidepressants, patients should be followed at least biweekly (preferably in-person) to monitor severity of depression, response to treatment and possible emergence of side-effects (including suicidal ideation, self-harming behavior).

For continuing treatment (3rd month and beyond) with SSRI antidepressants, patients should be followed at least monthly (in-person) to monitor severity of depression, response to treatment and possible emergence of side-effects (including suicidal ideation, self-harming behavior). Additional monitoring should be arranged as needed.

When adjusting doses (higher or lower) of SSRI antidepressants, patients should be followed weekly (in-person or by telephone) to monitor severity of depression, response to treatment and possible emergence of side-effects (including suicidal ideation, self-harming behavior) during the first month.

Patients and families should also be educated about the possible appearance of the following symptoms with these antidepressants: anxiety, agitation, panic attacks, insomnia, irritability; hostility/aggressiveness, impulsivity, restlessness (akathisia) and hypomania or mania. Parents/guardians should be advised to contact the prescribing physician when any of these symptoms occurs.

When starting an antidepressant, the prescribing physician should develop a “crisis/safety plan” with parents, families and patients with specific steps to follow so problems or concerns could be immediately communicated “after hours”.

Children and adolescents currently taking SSRI antidepressants should not suddenly stop their use or abruptly be taken off these antidepressant medications. Serious side effects can emerge (including suicidal ideation and self-harming behavior) with sudden discontinuation of these medications.

More careful research is needed to clarify the risk of suicidal behavior or thinking and the overall clinical effectiveness of antidepressant medications in depressed children and adolescents. Clinicians should continue to stay informed as new information on these issues becomes available from both research studies and the FDA.

The principles of practice and strategies for patient management contained in this advisory are not intended to define the standard of care, nor are they inclusive of all methods of care. The ultimate analysis and decision regarding the specific treatment of a particular child or adolescent patient must consider all the circumstances presented by the patient and his/her family and the diagnostic and treatment resources available.

Source: http://www.omh.state.ny.us/omhweb/advisories/programltr.htm NYS Office of Mental Health

This ‘Mental Health E-News’ posting is a service of the New York Ass’n of Psychiatric Rehabilitation Services, a statewide coalition of people who use and/or provide community mental health services dedicated to improving services and social conditions for people with psychiatric disabilities by promoting their recovery, rehabilitation and rights. To join our list, please click on the E-News Subscription button.