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Know The Risks...

Drugs That Appear To Increase The Risk Of Suicide...

The following articles deal with many drugs on which children with autism and those with other mental disorders are often placed... take note... most of these drugs were never tested on children... although, clearly, they are posing problems for adults too according to  articles posted on the Internet by both the FDA and the Associated Press - both dated March 22, 2004.   There are many, many parents posting "their story" on this issue of what drugs have done to their children.   I encourage you to do research in this area, to read what parents are saying and be informed as to the issues.

FDA Talk Paper, posted at: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html

FDA Issues Public Health Advisory on Cautions for Use of Antidepressants in Adults and Children

The Food and Drug Administration today issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

FDA has been closely reviewing the results of antidepressant studies in children, since June 2003, after an initial report on studies with paroxetine (Paxil), and subsequent reports on studies of other drugs, appeared to suggest an increased risk of suicidal thoughts and actions in the children given antidepressants. There were no suicides in any of the trials. On close examination of the initial reports, it was unclear whether certain behaviors reported in these studies represented actual suicide attempts, or other self-injurious behavior that was not suicide-related.

FDA has initiated a full review of these reported behaviors by experts in such evaluation. However, it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior. The agency is advising clinicians, patients, families and caregivers of adults and children that they should closely monitor all patients being placed on therapy with these drugs for worsening depression and suicidal thinking, which can occur during the early period of treatment. The agency is also advising that these patients be observed for certain behaviors that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania, and that physicians be particularly vigilant in patients who may have bipolar disorder.

FDA is asking manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Several of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the United States.

These interim actions follow recommendations made by FDA’s Psychopharmacologic Drugs and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees, which met on February 2, 2004. The advisory committee members advised FDA that the labeling should draw more attention to the need to monitor patients being treated with certain antidepressants.

FDA has previously noted (in Public Health Advisory and a Talk Paper T03-70 published Oct. 27, 2003) the possible finding of increased suicidal thinking or behavior, but emphasized that it was not clear that the drugs caused such events and additional analyses were being done to allow FDA to seek more definitive answers.

The Public Health Advisory containing the new label warnings and cautions is available online at http://www.fda.gov/cder/drug/antidepressants/default.htm.

Later this summer, FDA plans to update the Advisory Committees on the results of the expert analyses and its own analyses of the pediatric suicidality data.

This article is available at:  http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html

Below is the ASSOCIATED PRESS ARTICLE THAT APPEARED THE SAME DAY:  Suicide Warning Sought For Antidepressants by Lauran Neergaard. 

Suicide Warning Sought for Antidepressants
 

Mar 22, 3:06 PM (ET)

By LAURAN NEERGAARD

WASHINGTON (AP) - Doctors who prescribe some popular antidepressants should monitor their patients closely for warning signs of suicide, especially when they first start the pills or change a dose, the government warned Monday.

The Food and Drug Administration asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels.

The agency insists it's not yet clear whether the drugs actually spur suicide on occasion - or whether the underlying mental illness is to blame. But FDA bowed to pressure from anguished families who, at an emotional meeting last month, blamed the pills for their loved ones' suicides and pleaded for better warnings.

It's a difficult issue to sort out because depression itself can lead to suicide, and studies clearly show that antidepressants have helped many people recover from depression.

Still, until the question is settled, FDA's own scientific advisers had urged stronger warnings that certain antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.

Monday, FDA followed that recommendation, stressing that the most vulnerable time is when a patient starts therapy or changes the dose.

"We think this is good advice whether the drugs increase the risk or not," said FDA medical policy chief Dr. Robert Temple. "There's a reason people are put on therapy - their depression is worse or somebody's worried about it. Maybe that's what drives it (reports of suicides) or maybe it's the drugs. In either case, you really need to pay attention in the early days."

While FDA's investigation into the possible suicide link initially focused on children and teenagers, Monday's warning includes adults, too. The FDA had investigated reports of suicide among adult antidepressant users in the early 1990s and concluded there was no link - but on Monday revealed that it is reanalyzing that question.

The drugs of concern are newer generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro, Luvox, which are called SSRIs or SSRI-like drugs, and Remeron, Serzone and Wellbutrin, which operate differently.

Manufacturers didn't immediately say if they'd comply.

British health authorities sounded the alarm last year, saying long-suppressed research suggests serotonin-affecting antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Excepting only one drug, Prozac, that has been proven to alleviate pediatric depression, Britain declared the other six SSRIs or SSRI-like drugs unsuitable for depressed youth. Britain didn't mention the other three drugs listed in the U.S. notice.

FDA issued a caution on pediatric use last year but says it doesn't yet have proof the drugs are to blame. Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. Some 109 patients experienced one or more possibly suicide-related behaviors or attempts - but the studies varied dramatically in what was considered suicidal behavior. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding.

But critics flooded an FDA meeting last month demanding stronger action - and days later, the issue again made headlines when a 19-year-old woman taking part in a study of Eli Lilly & Co.'s experimental new antidepressant duloxetine hanged herself in a company-run facility.

Most antidepressant labels already contain some fine-print statement about suicide, usually that the possibility is inherent with depression.

FDA asked Monday for explicit explanations of worrisome behavior changes to be placed in bold print under the prominent "warnings" section of those labels: agitation, anxiety, irritability and recklessness. Doctors spotting those traits should consider prescribing a lower dose or stopping the drug, FDA said.

The drugs are used for many conditions other than depression; the warning applies regardless of the reason for use.

Critics welcomed the change but said suicide complaints first were raised many years ago.

"I'm just very sorry that it so long for them to act on this issue, because there's been so much tragedy that occurred," added Jennifer Tierney of Kernersville, N.C., who describes her daughter Jame as turning from a sweet, popular honor student into a raging loner after taking Effexor for migraines at age 14.

But psychiatrists caution that suicides have dropped as SSRI use has increased round the world.

"We do a disservice to a population of people who could benefit from these medications" by overreacting, said Dr. Bela Sood, chair of pediatric psychiatry at Virginia Commonwealth University.

Still, FDA's warning does alert doctors "who in a very lackadaisical way decide to put these kids on medications" to do a more thorough exam - and to tell parents what risks to watch for, Sood said.

Children in particular aren't good candidates for SSRIs if they're highly impulsive, angry or aggressive, she said. There also is a window period of risk just after pill use begins, before depression is really alleviated but when some patients experience more energy.

End Associated Press article by Lauran NEERGAARD

Note:  It is estimated that up to 40% of persons with schizophrenia attempt suicide, 10-15% complete.  :o(   There can be no denying that depression is very much associated with autism, schizophrenia and Alzheimer's and as such, I urge all to take these matters very, very seriously.   Personally, I am convinced these are the same disorder over the life spectrum... there are simply too many parallels among these disorders... not to mention the "very common ties in terms of "HISTORY OF THESE DISORDERS"!

Note:   The world's largest not-for-profit organization devoted to research on schizophrenia is called NARSAD:  The National Alliance For Research on Schizophrenia and DEPRESSION - because clearly - schizophrenia and depression are undeniably linked - as I believe are also autism, Alzheimer's and schizophrenia - for a whole lot more on this, I urge you to read Book 3!

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